Shamir R Mehta1, David A Wood1, Robert F Storey1, Roxana Mehran1, Kevin R Bainey1, Helen Nguyen1, Brandi Meeks1, Giuseppe Di Pasquale1, Jose López-Sendón1, David P Faxon1, Laura Mauri1, Sunil V Rao1, Laurent Feldman1, P Gabriel Steg1, Álvaro Avezum1, Tej Sheth1, Natalia Pinilla-Echeverri1, Raul Moreno1, Gianluca Campo1, Benjamin Wrigley1, Sasko Kedev1, Andrew Sutton1, Richard Oliver1, Josep Rodés-Cabau1, Goran Stanković1, Robert Welsh1, Shahar Lavi1, Warren J Cantor1, Jia Wang1, Juliet Nakamya1, Shrikant I Bangdiwala1, John A Cairns1. 1. From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (S.R.M., H.N., B.M., T.S., N.P.-E., J.N., J.W., S.I.B.), the University of British Columbia, Vancouver (D.A.W., J.A.C.), the University of Alberta, Mazankowski Alberta Heart Institute, Edmonton (K.R.B., R.W.), Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City (J.R.-C.), the University of Western Ontario, London Health Sciences Centre, London (S.L.), and the University of Toronto, Toronto Southlake Regional Health Centre, Toronto (W.J.C.) - all in Canada; the Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield (R.F.S.), the Royal Wolverhampton Hospitals NHS Trust, Wolverhampton (B.W.), the University Clinic of Cardiology, South Tees Hospitals NHS Foundation Trust, Middlesbrough (A.S.), and Hull University Teaching Hospitals NHS Trust, Hull (R.O.) - all in the United Kingdom; the Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (R.M.); Ospedale Maggiore, Bologna (G.D.P.), the Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona (G.C.), and Maria Cecilia Hospital, GVM Care and Research, Cotignola (G.C.) - all in Italy; University Hospital La Paz, Madrid (J.L.-S., R.M.); Brigham and Women's Hospital and Harvard Medical School, Boston (D.P.F., L.M.); Duke University Medical Center, Durham, NC (S.V.R.); Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris (L.F., P.G.S.); Hospital Alemão Oswaldo Cruz, Instituto Dante Pazzanese de Cardiologia, São Paulo (A.A.); the University Clinic of Cardiology, University St. Cyril and Methodius, Skopje, Macedonia (S.K.); and the Clinical Center of Serbia, Belgrade (G.S.).
Abstract
BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS: We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS: At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P = 0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P<0.001). For both coprimary outcomes, the benefit of complete revascularization was consistently observed regardless of the intended timing of nonculprit-lesion PCI (P = 0.62 and P = 0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS: Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.).
RCT Entities:
BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS: We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS: At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P = 0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P<0.001). For both coprimary outcomes, the benefit of complete revascularization was consistently observed regardless of the intended timing of nonculprit-lesion PCI (P = 0.62 and P = 0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS: Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.).
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