比伐卢定与肝素单药治疗心肌梗死的比较。
Bivalirudin versus Heparin Monotherapy in Myocardial Infarction.
机构信息
From the Department of Cardiology, Clinical Sciences, Lund University, Lund (D.E., P.B., A.L., T.T., M.G., F.S., S.K.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (E.O., D.I., T.R., O.A.), the Department of Cardiology, Faculty of Health, Örebro University, Örebro (O.F., T.K., L.Z.), the Department of Cardiology, Danderyd Hospital (R.L.), and the Department of Cardiology, Karolinska University Hospital (L.H.), Karolinska Institutet, the Department of Cardiology, Capio St. Görans Hospital (J.J., P.L.), and the Department of Cardiology, Södersjukhuset AB (M.A.), Stockholm, PCI-Unit at Karlstad Hospital, Karlstad (M.D.), the Department of Cardiology, Mälarsjukhuset, Eskilstuna (M.H.), the Department of Cardiology, Linköping University Hospital, Linköping (E.S.), the Department of Cardiology, Helsingborg Lasarett, Helsingborg (H. Wagner), the Department of Cardiology, Halmstad Hospital, Halmstad (P.H.), the Department of Cardiology, Falun Hospital, Falun (I.S.), the Department of Cardiology, Skaraborgs Hospital, Skövde (J.S.), the Department of Internal Medicine, Västmanlands Sjukhus, Västerås (P.G.), the Department of Cardiology, Södra Älvsborgs Sjukhus, Borås (L.R.), the Department of Cardiology, Sunderby Sjukhus, Luleå (J.H.), the Department of Cardiology, Kristianstad Hospital, Kristianstad (H. Wikström), the Department of Cardiology, Östersund Hospital, Östersund (A.U.), the Department of Cardiology, Sundsvall Hospital, Sundsvall (B. Lindvall), the Department of Cardiology, Umeå University, Umeå (J.A., P.E.), and the Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala (O.Ö., B. Lagerqvist, C.H., L.W., S.J.) - all in Sweden.
出版信息
N Engl J Med. 2017 Sep 21;377(12):1132-1142. doi: 10.1056/NEJMoa1706443. Epub 2017 Aug 27.
BACKGROUND
The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors.
METHODS
In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up.
RESULTS
A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76).
CONCLUSIONS
Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy. (Funded by the Swedish Heart-Lung Foundation and others; VALIDATE-SWEDEHEART ClinicalTrialsRegister.eu number, 2012-005260-10 ; ClinicalTrials.gov number, NCT02311231 .).
背景
根据目前的实践，在接受经皮冠状动脉介入治疗（PCI）的急性心肌梗死患者中，各种抗凝策略的相对疗效尚不清楚，目前的实践包括使用桡动脉入路进行 PCI 以及使用强效 P2Y 抑制剂而不计划使用糖蛋白 IIb/IIIa 抑制剂。
方法
在这项多中心、随机、基于注册、开放性临床试验中，我们招募了接受 PCI 治疗且正在接受强效 P2Y 抑制剂（替卡格雷、普拉格雷或坎格瑞洛）治疗且不计划使用糖蛋白 IIb/IIIa 抑制剂的 ST 段抬高型心肌梗死（STEMI）或非 ST 段抬高型心肌梗死（NSTEMI）患者。患者被随机分配在 PCI 期间接受比伐卢定或肝素治疗，PCI 主要采用桡动脉入路。主要终点是 180 天随访期间任何原因导致的死亡、心肌梗死或大出血的复合终点。
结果
共有 6006 名患者（3005 名 STEMI 患者和 3001 名 NSTEMI 患者）入组该试验。在 180 天时，在比伐卢定组中，12.3%（369/3004）的患者发生了主要终点事件，在肝素组中，12.8%（383/3002）的患者发生了主要终点事件（风险比，0.96；95%置信区间 [CI]，0.83 至 1.10；P=0.54）。结果在 STEMI 患者和 NSTEMI 患者以及其他主要亚组中一致。比伐卢定组中有 2.0%的患者发生心肌梗死，肝素组中有 2.4%（风险比，0.84；95%CI，0.60 至 1.19；P=0.33），大出血分别为 8.6%和 8.6%（风险比，1.00；95%CI，0.84 至 1.19；P=0.98），明确的支架血栓形成分别为 0.4%和 0.7%（风险比，0.54；95%CI，0.27 至 1.10；P=0.09），死亡分别为 2.9%和 2.8%（风险比，1.05；95%CI，0.78 至 1.41；P=0.76）。
结论
在接受心肌梗死 PCI 治疗的患者中，接受比伐卢定治疗的患者与接受肝素单药治疗的患者的任何原因导致的死亡、心肌梗死或大出血复合终点发生率没有降低。（由瑞典心肺基金会和其他机构资助；VALIDATE-SWEDEHEART 临床试验注册处.eu 编号，2012-005260-10；ClinicalTrials.gov 编号，NCT02311231）。
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