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Slide 1 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary
Slide 2 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins
Slide 3 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS
Slide 4 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose
Slide 5 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads
Slide 6 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design
Slide 7 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN
Slide 8 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete
Slide 9 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate
Slide 10 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days)
Slide 11 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina
Slide 12 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back !
Slide 13 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy
Slide 14 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it?
Slide 15 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50%
Slide 16 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months
Slide 17 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11
Slide 18 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly
Slide 19 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7
Slide 20 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue
Slide 21 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005
Slide 22 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival
Slide 23 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG
Slide 24 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis
Slide 25 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators
Slide 26 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF
Slide 27 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF n=427 RESULTS
Slide 28 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF n=427 RESULTS Primary composite endpoint: Death and non-fatal re-AMI, CVA , Severe HF p= 0.78 p = 0.0009 p = 0.002 6 Months RESULTS Gr A N=142 R-LYSIS Gr B N=141 Conservative Gr C N=144 R-PCI 44 (31.0%) 42 (29.8%) 22 (15.3%)
Slide 29 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF n=427 RESULTS Primary composite endpoint: Death and non-fatal re-AMI, CVA , Severe HF p= 0.78 p = 0.0009 p = 0.002 6 Months RESULTS Gr A N=142 R-LYSIS Gr B N=141 Conservative Gr C N=144 R-PCI 44 (31.0%) 42 (29.8%) 22 (15.3%) Rank log p=0.004 RESULTS 6 months
Slide 30 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF n=427 RESULTS Primary composite endpoint: Death and non-fatal re-AMI, CVA , Severe HF p= 0.78 p = 0.0009 p = 0.002 6 Months RESULTS Gr A N=142 R-LYSIS Gr B N=141 Conservative Gr C N=144 R-PCI 44 (31.0%) 42 (29.8%) 22 (15.3%) Rank log p=0.004 RESULTS 6 months p=0.13 Mortality at 6 months
Slide 31 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF n=427 RESULTS Primary composite endpoint: Death and non-fatal re-AMI, CVA , Severe HF p= 0.78 p = 0.0009 p = 0.002 6 Months RESULTS Gr A N=142 R-LYSIS Gr B N=141 Conservative Gr C N=144 R-PCI 44 (31.0%) 42 (29.8%) 22 (15.3%) Rank log p=0.004 RESULTS 6 months p=0.13 Mortality at 6 months Hierarchical Analysis at 6 Months Death 12.7 (10.6) 12.8 (9.9) 6.3(5.6) Re AMI 10.6 8.5 2.1 CVA 0.7 0.7 2.1 Severe HF 7.0 7.8 4.9 Re-Lysis (A) Conservative (B) R-PCI (C) B v C p=0.06 A v B v C p=0.007
Slide 32 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF n=427 RESULTS Primary composite endpoint: Death and non-fatal re-AMI, CVA , Severe HF p= 0.78 p = 0.0009 p = 0.002 6 Months RESULTS Gr A N=142 R-LYSIS Gr B N=141 Conservative Gr C N=144 R-PCI 44 (31.0%) 42 (29.8%) 22 (15.3%) Rank log p=0.004 RESULTS 6 months p=0.13 Mortality at 6 months Hierarchical Analysis at 6 Months Death 12.7 (10.6) 12.8 (9.9) 6.3(5.6) Re AMI 10.6 8.5 2.1 CVA 0.7 0.7 2.1 Severe HF 7.0 7.8 4.9 Re-Lysis (A) Conservative (B) R-PCI (C) B v C p=0.06 A v B v C p=0.007 MAJOR MINOR ( > 3g/dl) ( 2g/dl -3 g/dl) 5 15 20 10 OVERT Bld No OVERT Bld OVERT Bld No OVERT Bld 4.9 2.1 18.7 3.5 8.5 8.4 22/27 (82%) sheath % <0.0003 Bleeding Outcomes 9/9 (100%) sheath 15.5 6.2 3.5 3.5 15.6 10.4 ns Lysis C RPCI Lysis C RPCI Lysis C RPCI Lysis C RPCI Fatal Bleeding complications Rescue: 0 Conservative: 3 Repeat Thrombolysis: 5
Slide 33 - London 27/1/2005 TRIAL VIGNETTES Andreas Baumbach Bristol Heart Institute Bristol Royal Infirmary Revascularisation in ACS ICTUS MERLIN REACT 4mins 4mins 4mins Tony’s Comments 15mins ICTUS Comparison of an early invasive with a selective invasive strategy in pts presenting with Trop positive ACS ESC Hotline-II Robbert J de Winter MD PhD FESC Academic Medical Center Department of Cardiology University of Amsterdam No financial interests to disclose Design Inclusion criteria Anginal symptoms at rest < 24 hours Troponin T concentration  0.03 ng/L And one of the following: Documented history of coronary artery disease Ischemic changes on the ECG ST-segment depression  0.05 mV Transient ST‑segment elevation T-wave changes  0.2 mV in two contiguous leads NSTE-ACS Trop T pos Death, MI, or ACS Abciximab during all PCI procedures Selective invasive Early invasive Aspirin Enoxaparin Clopidogrel Statins CAG Medical Rx PCI / CABG Medical Rx CAG / PCI / CABG ETT Chest pain - 24 hrs Random. 0 hrs Refractory angina - + 24-48 hrs 1 year Design Study design 1o endpoint: Death, MI*, Rehospitalization for ACS Power: Early invasive strategy superior Endpoint reduction from 28% to 21% 80% power Sample size: 2 x 600 patients Design Statistics *Peak CK-MB > 1 x ULN; serial sampling every 6 hrs In patients with elevated CK-MB at randomization, at least 50% decrease with subsequent rise > 1 x ULN Results Results 42 participating Dutch centers, 12 intervention centers 1201 patients randomized between July 2001- August 2003 Early invasive: 604 patients Selective invasive: 597 patients One year follow-up (August 20th 2004), 98% complete 100 200 300 20% 40% 60% 80% 100% 73% 47% Time (days) Results Revascularization over time Early invasive: 97% CAG Selective invasive: 67% CAG Highest Angio/Revascularisation Rate 10% 20% 30% 100 200 300 Death, MI, Rehospitalization for ACS 21.7% 20.4% Results Relative Risk: 1.06 95% CI: 0.85 – 1.32 P = 0.59 Time (days) Events at one year Death New or recurrent MI Rehosp. for ACS Primary endpoint P-value 0.86 0.006 0.017 0.59 2.2 14.6 7.0 21.7 Early invasive (%) 2.0 9.4 10.9 20.4 Selective invasive (%) Results 1.07 1.55 0.63 1.06 Relative Risk No difference in Angina Conclusion An early invasive strategy was not superior to a selective invasive strategy for NSTE-ACS Use of active risk stratification, and liberal use of coronary angiography is a good treatment option The treadmill is back ! MERLIN Comparison of Rescue angioplasty for failed thrombolysis with a conservative strategy MERLIN Mark de Belder The James Cook University Hospital Middlesbrough Is rescue angioplasty worth it? MERLIN METHODS Inclusion Criteria STEMI and evidence of “failure to reperfuse” Presentation to hospital within 10 hours of symptoms “Failure to reperfuse” at 60 min ECG: Failure of the ST segment elevation in the worst lead to have resolved by 50% Endpoints Primary end point: 30 day all cause mortality Secondary endpoints: i) 30 day composite of death, reinfarction, stroke, heart failure, unplanned revascularisation ii) Left ventricular function at 30 days assessed by the RWMI. iii) Further analysis at 6, 12, 24, 36 months MERLIN Results: 30 days p=0.7 p=0.02 P=0.7 P=0.3 P=0.03 P=0.0004 P=0.3 Sutton AGC, Campbell PG, Graham R et al. JACC 2004;44:287-96 9.8 11 MERLIN Results in the elderly 30 day Kaplan-Meier survival curve 0 10 20 30 0 25 50 75 100 % Days Conservative Rescue p=0.7 30 day Kaplan-Meier event free survival curve 0 10 20 30 0 25 50 75 100 Days % p=0.02 Conservative Rescue MERLIN – 1yr event free survival p=0.005 MERLIN – 1yr survival Conclusion No early mortality benefit Less urgent revascularisations At 1 yr there is no mortality benefit for a strategy of rescue angioplasty based on the 60 mins ECG REACT Comparison of Rescue angioplasty, repeat thrombolysis and conservative treatment for failed thrombolysis Steering Committee A.H.Gershlick (PI) M de Belder H Swanton R.Wilcox K Abrams David de Bono Data & Safety End Point Committee Kim Fox J. Birkhead M. Bland J.Hampton S Davies Trial Co-Ordinators/ Monitors Sarah Hughes Amanda Stephens-Lloyd Independent Statistician Suzanne Stevens/ Alan Skene Dr N Uren Dr A de Belder Dr J Davis Dr M Pitt Dr F Alamgir Dr A Banning Dr A Baumbach Dr MF Shiu Dr B Vallance Dr P Schofield Dr K Dawkins Prof P Weissberg Dr R Henderson Dr E Leatham Dr M Malekian Dr M Millar-Craig Dr S Redwood Dr S Odemuyiwa Dr P Walker Dr E Lee Dr K Oldroyd Dr D O'Neill Dr N Curzen Dr S Hood Dr D Hackett Dr C Lawson Dr H Swanton Dr R Foale Dr W Penny Dr D Smith Dr I Squire Dr I Hudson Dr M.Norell All Investigators REACT (REscue Angioplasty v Conservative treatment or repeat Thrombolysis) ECG 90 min post (any) thrombolytic ST < 50 % resolution (with or without pain) CONSENT & RANDOMISE (IF PCI possible within 12hrs of CP) Conservative 2 nd thrombolytic Coronary Angio 24 iv heparin Acelerated tPA or +/- PCI Reteplase P. End point: 6/12 ~death/re-infarction/CVA / severe HF n=427 RESULTS Primary composite endpoint: Death and non-fatal re-AMI, CVA , Severe HF p= 0.78 p = 0.0009 p = 0.002 6 Months RESULTS Gr A N=142 R-LYSIS Gr B N=141 Conservative Gr C N=144 R-PCI 44 (31.0%) 42 (29.8%) 22 (15.3%) Rank log p=0.004 RESULTS 6 months p=0.13 Mortality at 6 months Hierarchical Analysis at 6 Months Death 12.7 (10.6) 12.8 (9.9) 6.3(5.6) Re AMI 10.6 8.5 2.1 CVA 0.7 0.7 2.1 Severe HF 7.0 7.8 4.9 Re-Lysis (A) Conservative (B) R-PCI (C) B v C p=0.06 A v B v C p=0.007 MAJOR MINOR ( > 3g/dl) ( 2g/dl -3 g/dl) 5 15 20 10 OVERT Bld No OVERT Bld OVERT Bld No OVERT Bld 4.9 2.1 18.7 3.5 8.5 8.4 22/27 (82%) sheath % <0.0003 Bleeding Outcomes 9/9 (100%) sheath 15.5 6.2 3.5 3.5 15.6 10.4 ns Lysis C RPCI Lysis C RPCI Lysis C RPCI Lysis C RPCI Fatal Bleeding complications Rescue: 0 Conservative: 3 Repeat Thrombolysis: 5 Conclusion REACT shows a clear benefit of rescue angioplasty for failed thrombolysis Comparison with MERLIN will be important Forget Re-thrombolysis !