Peter R Sinnaeve1, Paul W Armstrong1, Anthony H Gershlick1, Patrick Goldstein1, Robert Wilcox1, Yves Lambert1, Thierry Danays1, Louis Soulat1, Sigrun Halvorsen1, Fernando Rosell Ortiz1, Katleen Vandenberghe1, Anne Regelin1, Erich Bluhmki1, Kris Bogaerts1, Frans Van de Werf2. 1. From the Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium (P.R.S., K.V., F.V.d.W.); The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (Canadian VIGOUR Centre), University of Alberta, Edmonton, Canada (P.W.A); NIHR, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, Leicester, United Kingdom (A.H.G.); Emergency Department and SAMU, Lille University Hospital, Lille, France (P.G.); the Department of Cardiovascular Medicine, University of Nottingham, Nottingham, United Kingdom (R.W.); Centre Hospitalier de Versailles, SAMU 78 and Mobile Intensive Care Unit, Versailles, France (Y.L.); Boehringer Ingelheim, Reims, France (T.D.); Centre Hospitalier Châteauroux, SAMU/SMUR/Urgences, Châteauroux, France (L.S.); the Department of Cardiology, Oslo University Hospital Ulleval, Oslo, Norway (S.H.); Empresa Pública de Emergencias Sanitarias, Almería, Spain (F.R.O.); Clinical Trials Unit, University Medical Center Freiburg, Freiburg, Germany (A.R.); Boehringer Ingelheim, Biberach, Germany (E.B.); and the Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium (K.B.). 2. From the Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium (P.R.S., K.V., F.V.d.W.); The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (Canadian VIGOUR Centre), University of Alberta, Edmonton, Canada (P.W.A); NIHR, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, Leicester, United Kingdom (A.H.G.); Emergency Department and SAMU, Lille University Hospital, Lille, France (P.G.); the Department of Cardiovascular Medicine, University of Nottingham, Nottingham, United Kingdom (R.W.); Centre Hospitalier de Versailles, SAMU 78 and Mobile Intensive Care Unit, Versailles, France (Y.L.); Boehringer Ingelheim, Reims, France (T.D.); Centre Hospitalier Châteauroux, SAMU/SMUR/Urgences, Châteauroux, France (L.S.); the Department of Cardiology, Oslo University Hospital Ulleval, Oslo, Norway (S.H.); Empresa Pública de Emergencias Sanitarias, Almería, Spain (F.R.O.); Clinical Trials Unit, University Medical Center Freiburg, Freiburg, Germany (A.R.); Boehringer Ingelheim, Biberach, Germany (E.B.); and the Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium (K.B.). frans.vandewerf@med.kuleuven.be.
Abstract
BACKGROUND: In the Strategic Reperfusion Early After Myocardial Infarction (STREAM) trial, a pharmaco-invasive (PI) strategy was compared with primary percutaneous coronary intervention (pPCI) in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset but unable to undergo pPCI within 1 hour. At 30 days, the PI approach was associated with a nominally but nonstatistically significant lower incidence of the composite primary end point of death, shock, congestive heart failure, and reinfarction when compared with pPCI. The aim of the present study was to determine the effect of these strategies on 1-year mortality. METHODS AND RESULTS:Vital status at 1 year was available in 936 of 944 (99.2%) and 941 of 948 (99.3%) patients in the PI and pPCI arm, respectively. At 1 year, all-cause mortality rates (6.7% versus 5.9%) were similar for PI and pPCI-treated patients (P=0.49; risk ratio, 1.13; 95% confidence interval, 0.79-1.62). Cardiac mortality rates were similar as well (4.0% versus 4.1%, P=0.93; risk ratio, 0.98; 95% confidence interval, 0.62-1.54). Overall, only 34 patients died between day 30 and 1 year, 20 in the PI arm and 14 in the pPCI arm, of whom 20 died of noncardiac reasons (13 in the PI and 7 in the pPCI arm). There was no significant difference in 1-year all-cause mortality between the 2 groups among the prespecified key subgroups. CONCLUSIONS: At 1 year, mortality rates in the PI and pPCI arms were similar in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset and unable to undergo pPCI within 1 hour. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00623623.
RCT Entities:
BACKGROUND: In the Strategic Reperfusion Early After Myocardial Infarction (STREAM) trial, a pharmaco-invasive (PI) strategy was compared with primary percutaneous coronary intervention (pPCI) in ST-segment-elevation myocardial infarctionpatients presenting within 3 hours after symptom onset but unable to undergo pPCI within 1 hour. At 30 days, the PI approach was associated with a nominally but nonstatistically significant lower incidence of the composite primary end point of death, shock, congestive heart failure, and reinfarction when compared with pPCI. The aim of the present study was to determine the effect of these strategies on 1-year mortality. METHODS AND RESULTS: Vital status at 1 year was available in 936 of 944 (99.2%) and 941 of 948 (99.3%) patients in the PI and pPCI arm, respectively. At 1 year, all-cause mortality rates (6.7% versus 5.9%) were similar for PI and pPCI-treated patients (P=0.49; risk ratio, 1.13; 95% confidence interval, 0.79-1.62). Cardiac mortality rates were similar as well (4.0% versus 4.1%, P=0.93; risk ratio, 0.98; 95% confidence interval, 0.62-1.54). Overall, only 34 patients died between day 30 and 1 year, 20 in the PI arm and 14 in the pPCI arm, of whom 20 died of noncardiac reasons (13 in the PI and 7 in the pPCI arm). There was no significant difference in 1-year all-cause mortality between the 2 groups among the prespecified key subgroups. CONCLUSIONS: At 1 year, mortality rates in the PI and pPCI arms were similar in ST-segment-elevation myocardial infarctionpatients presenting within 3 hours after symptom onset and unable to undergo pPCI within 1 hour. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00623623.
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