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.).
N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.
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.
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.
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).
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.).
在 ST 段抬高型心肌梗死(STEMI)患者中,经皮冠状动脉介入治疗(PCI)罪犯病变可降低心血管死亡或心肌梗死的风险。但 PCI 非罪犯病变是否进一步降低此类事件的风险尚不清楚。
我们随机分配接受成功罪犯病变 PCI 的 STEMI 伴多支血管病变患者,一组采用 PCI 完全血运重建策略治疗有意义的非罪犯病变,另一组不进一步血运重建。随机分组根据非罪犯病变 PCI 的预期时机(在指数住院期间或之后)分层。主要复合终点为心血管死亡或心肌梗死;次要复合终点为心血管死亡、心肌梗死或缺血驱动的血运重建。
中位随访 3 年期间,完全血运重建组 2016 例患者中有 158 例(7.8%)发生主要复合终点事件,而罪犯病变 PCI 组 2025 例患者中有 213 例(10.5%)发生(风险比 0.74;95%置信区间 0.60 至 0.91;P=0.004)。完全血运重建组中 179 例(8.9%)发生次要复合终点事件,而罪犯病变 PCI 组中 339 例(16.7%)发生(风险比 0.51;95%置信区间 0.43 至 0.61;P<0.001)。对于主要复合终点,无论非罪犯病变 PCI 的预期时机如何,完全血运重建的获益均一致(首次和次要主要复合终点的交互 P 值分别为 0.62 和 0.27)。
在 STEMI 伴多支血管病变患者中,与仅罪犯病变 PCI 相比,完全血运重建可降低心血管死亡或心肌梗死风险,以及心血管死亡、心肌梗死或缺血驱动的血运重建风险。(由加拿大卫生研究院和其他机构资助;COMPLETE 临床试验.gov 编号,NCT01740479。)