bd Vincent Auriol, Institut de Cardiologie, Hôpital Pitié-Salpétrière, Paris, France.
Trials. 2013 Feb 21;14:56. doi: 10.1186/1745-6215-14-56.
Dual antiplatelet therapy with aspirin and thienopyridine is required after placement of coronary drug-eluting stents (DES) to prevent thrombotic complications. Current clinical guidelines recommend at least 6 to 12 months of treatment after a DES implantation, but it may be beneficial to apply dual antiplatelet therapy for a longer duration.
METHODS/DESIGN: The optimal dual antiplatelet therapy (OPTIDUAL) study aims to compare the benefits and risks of dual antiplatelet therapy applied for either 12 or 48 months. We will examine the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention with DES for the treatment of coronary lesions. The OPTIDUAL study is an open-label multicenter, randomized, national trial that will include 1,966 patients treated with DES. All patients will be treated with dual antiplatelet therapy for 12 months (+/- 3). Then, patients with no MACCE or major bleeding will be randomized to receive either 36 additional months of clopidogrel plus aspirin or aspirin only. The primary end-point is the combination of death from all causes, myocardial infarction, stroke and major bleeding. The secondary end points include the individual components of the primary end-point, stent thrombosis, repeat revascularization of the treated vessel and minor bleeding.
This randomized trial is designed to assess the benefits and safety of 12 versus 48 months of dual antiplatelet therapy in patients that receive a DES. We aim to determine whether substantial prolongation of clopidogrel (a thienopyridine) after DES implantation offers an advantage over its discontinuation.
ClinicalTrials.gov Identifier: NCT00822536.
在放置冠状动脉药物洗脱支架（DES）后，需要使用阿司匹林和噻吩吡啶进行双联抗血小板治疗，以预防血栓并发症。目前的临床指南建议在 DES 植入后至少进行 6 至 12 个月的治疗，但将双联抗血小板治疗延长更长时间可能会有益。
方法/设计：最佳双联抗血小板治疗（OPTIDUAL）研究旨在比较应用双联抗血小板治疗 12 个月或 48 个月的获益和风险。我们将检查接受经皮冠状动脉介入治疗（DES）治疗冠状动脉病变的患者主要不良心血管和脑血管事件（MACCE）的发生情况。OPTIDUAL 研究是一项开放标签、多中心、随机、全国性试验，将包括 1966 例接受 DES 治疗的患者。所有患者将接受双联抗血小板治疗 12 个月（+/-3）。然后，无 MACCE 或大出血的患者将被随机分为接受氯吡格雷加阿司匹林或阿司匹林加 36 个月的额外治疗。主要终点是所有原因导致的死亡、心肌梗死、卒中和大出血的组合。次要终点包括主要终点的各个组成部分、支架血栓形成、治疗血管的再次血运重建和轻度出血。
这项随机试验旨在评估接受 DES 的患者接受 12 个月与 48 个月双联抗血小板治疗的获益和安全性。我们旨在确定 DES 植入后氯吡格雷（噻吩吡啶）的延长使用是否优于停药。
ClinicalTrials.gov 标识符：NCT00822536。
