Payam Dehghani1, Warren J Cantor2, Jia Wang3,4, David A Wood5, Robert F Storey6, Roxana Mehran7, Kevin R Bainey8, Robert C Welsh8, Josep Rodés-Cabau9, Sunil Rao10, Shahar Lavi11, James L Velianou3, Madhu K Natarajan3,4, Antonios Ziakas12, Vincenzo Guiducci13, Francisco Fernández-Avilés14, John A Cairns5, Shamir R Mehta3,4. 1. Prairie Vascular Research Network, University of Saskatchewan, Regina, Canada (P.D.). 2. Toronto Southlake Regional Health Centre, University of Toronto, Ontario, Canada (W.J.C.). 3. Hamilton Health Sciences, McMaster University, Ontario, Canada (J.W., J.L.V., M.K.N., S.R.M.). 4. Population Health Research Institute, Hamilton, Ontario, Canada (J.W., M.K.N., S.R.M.). 5. Centre for Cardiovascular Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Canada (D.A.W., J.A.C.). 6. Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, United Kingdom (R.F.S.). 7. The Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.). 8. Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (K.R.B., R.C.W.). 9. Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada (J.R.-C.). 10. Duke University Medical Center, Durham, NC (S.R.). 11. London Health Sciences Centre, University of Western Ontario, Canada (S.L.). 12. AHEPA University Hospital, Aristotle University of Thessaloniki, Greece (A.Z.). 13. Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy (V.G.). 14. Hospital General Universitario Gregorio Marañon, Madrid, Spain (F.F.-A.).
Abstract
BACKGROUND: The COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI) demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular events in patients with ST-segment-elevation myocardial infarction and multivessel coronary artery disease. It is unclear whether consistent benefit is observed in patients undergoing a pharmacoinvasive strategy compared with primary PCI. METHODS: Following culprit lesion PCI, 4041 patients with ST-segment-elevation myocardial infarction and multivessel coronary artery disease were randomized to either routine nonculprit lesion PCI or culprit lesion only PCI. In a prespecified analysis, we determined the treatment effect in 303 patients undergoing a pharmacoinvasive strategy versus 3738 patients undergoingprimary PCI on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. RESULTS: The first coprimary was reduced with complete revascularization both in the patients undergoing a pharmacoinvasive strategy (2.1%/y versus 4.7%/y, hazard ratio, 0.45 [95% CI, 0.21-0.97]) and in patients undergoing primary PCI (2.7%/y versus 3.6%/y, hazard ratio, 0.77 [95% CI, 0.62-0.95]; interaction P=0.18). The second coprimary outcome was reduced with complete revascularization in patients undergoing a pharmacoinvasive strategy (2.3%/y versus 8.5%/y, hazard ratio, 0.28 [95% CI, 0.14-0.56]), and in patients undergoing primary PCI (3.2%/y versus 6.0%/y, hazard ratio, 0.53 [95% CI, 0.44-0.64], interaction P=0.07). CONCLUSIONS: Among patients with ST-segment-elevation myocardial infarction and multivessel disease, complete revascularization withmultivessel PCI consistently reduces major cardiovascular events in patients undergoing an initial pharmacoinvasive strategy as well as in those undergoing primary PCI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01740479.
RCT Entities:
BACKGROUND: The COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multi-Vessel Disease After Early PCI for STEMI) demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular events in patients with ST-segment-elevation myocardial infarction and multivessel coronary artery disease. It is unclear whether consistent benefit is observed in patients undergoing a pharmacoinvasive strategy compared with primary PCI. METHODS: Following culprit lesion PCI, 4041 patients with ST-segment-elevation myocardial infarction and multivessel coronary artery disease were randomized to either routine nonculprit lesion PCI or culprit lesion only PCI. In a prespecified analysis, we determined the treatment effect in 303 patients undergoing a pharmacoinvasive strategy versus 3738 patients undergoing primary PCI on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. RESULTS: The first coprimary was reduced with complete revascularization both in the patients undergoing a pharmacoinvasive strategy (2.1%/y versus 4.7%/y, hazard ratio, 0.45 [95% CI, 0.21-0.97]) and in patients undergoing primary PCI (2.7%/y versus 3.6%/y, hazard ratio, 0.77 [95% CI, 0.62-0.95]; interaction P=0.18). The second coprimary outcome was reduced with complete revascularization in patients undergoing a pharmacoinvasive strategy (2.3%/y versus 8.5%/y, hazard ratio, 0.28 [95% CI, 0.14-0.56]), and in patients undergoing primary PCI (3.2%/y versus 6.0%/y, hazard ratio, 0.53 [95% CI, 0.44-0.64], interaction P=0.07). CONCLUSIONS: Among patients with ST-segment-elevation myocardial infarction and multivessel disease, complete revascularization with multivessel PCI consistently reduces major cardiovascular events in patients undergoing an initial pharmacoinvasive strategy as well as in those undergoing primary PCI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01740479.