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用于冠状动脉疾病的药物洗脱支架或裸金属支架

Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease.

作者信息

Bønaa Kaare H, Mannsverk Jan, Wiseth Rune, Aaberge Lars, Myreng Yngvar, Nygård Ottar, Nilsen Dennis W, Kløw Nils-Einar, Uchto Michael, Trovik Thor, Bendz Bjørn, Stavnes Sindre, Bjørnerheim Reidar, Larsen Alf-Inge, Slette Morten, Steigen Terje, Jakobsen Ole J, Bleie Øyvind, Fossum Eigil, Hanssen Tove A, Dahl-Eriksen Øystein, Njølstad Inger, Rasmussen Knut, Wilsgaard Tom, Nordrehaug Jan E

机构信息

From the Department of Community Medicine (K.H.B., I.N., T.W.) and the Department of Clinical Medicine (T.S., T.A.H., K.R.), University of Tromsø-the Arctic University of Norway, and the Department of Cardiology, University Hospital of North Norway (J.M., T.T., T.S., T.A.H., Ø.D.-E., K.R.), Tromsø, the Departments of Public Health and General Medicine (K.H.B.) and Circulation and Medical Imaging (R.W.), Norwegian University of Science and Technology, and the Clinic for Heart Disease, St. Olav's University Hospital (K.H.B., R.W., M.S.), Trondheim, the Departments of Cardiology (L.A., B.B., E.F.), Radiology, (N.-E.K.), and Heart Disease (R.B.), Oslo University Hospital, and the Faculty of Medicine, University of Oslo (N.-E.K., B.B.), Oslo, the Department of Cardiology, Feiring Heart Clinic, Feiring (Y.M., S.S.), the Department of Heart Disease, Haukeland University Hospital (O.N., Ø.B.), and the Department of Clinical Science, University of Bergen (O.N., D.W.N., A.-I.L., J.E.N.), Bergen, the Department of Cardiology, Stavanger University Hospital, Stavanger (D.W.N., A.-I.L., J.E.N.), and the Department of Medicine, Sørlandet Hospital, Arendal (M.U., O.J.J.) - all in Norway.

出版信息

N Engl J Med. 2016 Sep 29;375(13):1242-52. doi: 10.1056/NEJMoa1607991. Epub 2016 Aug 29.

DOI:10.1056/NEJMoa1607991

PMID:27572953

Abstract

BACKGROUND

Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life.

METHODS

We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of either contemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life.

RESULTS

At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups.

CONCLUSIONS

In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).

摘要

背景

关于当代药物洗脱支架与当代裸金属支架对死亡率、心肌梗死、再次血管重建、支架血栓形成率及生活质量的长期影响，现有数据有限。

方法

我们将9013例患有稳定或不稳定冠状动脉疾病的患者随机分配，使其接受经皮冠状动脉介入治疗（PCI），植入当代药物洗脱支架或裸金属支架。在接受药物洗脱支架的组中，96%的患者接受了依维莫司洗脱支架或佐他莫司洗脱支架。主要结局是在中位随访5年后，任何原因导致的死亡与非致命性自发性心肌梗死的复合结局。次要结局包括再次血管重建、支架血栓形成及生活质量。

结果

在6年时，接受药物洗脱支架组的主要结局发生率为16.6%，接受裸金属支架组为17.1%（风险比，0.98；95%置信区间[CI]，0.88至1.09；P = 0.66）。主要结局的各组成部分在组间无显著差异。接受药物洗脱支架组的任何再次血管重建6年发生率为16.5%，接受裸金属支架组为19.8%（风险比，0.76；95%CI，0.69至0.85；P<0.001）；明确的支架血栓形成率分别为0.8%和1.2%（P = 0.0498）。两组间生活质量指标无显著差异。