Rubboli Andrea, Saia Francesco, Sciahbasi Alessandro, Bacchi-Reggiani Maria Letizia, Steffanon Luigi, Briguori Carlo, Calabrò Paolo, Palmieri Cataldo, Rizzi Andrea, Imperadore Ferdinando, Sangiorgi Giuseppe M, Valgimigli Marco, Carosio Giuseppe, Steffenino Giuseppe, Galvani Marcello, Di Pasquale Giuseppe, La Vecchia Luigi, Maggioni Aldo P, Bolognese Leonardo
Division of Cardiology, Laboratory of Interventional Cardiology, Ospedale Maggiore, Largo Nigrisoli 2, 40133 Bologna, Italy.
J Invasive Cardiol. 2014 Nov;26(11):563-9.
To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S).
The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined.
We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period.
Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases.
In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.
获取关于抗血栓治疗方案疗效和安全性的进一步且更具针对性的信息,这些方案包括华法林、阿司匹林和氯吡格雷的三联疗法(TT);华法林与单一抗血小板药物(阿司匹林或氯吡格雷)的双联疗法(DT);以及阿司匹林和氯吡格雷的双联抗血小板疗法(DAPT),用于接受经皮冠状动脉介入治疗并植入支架(PCI-S)的口服抗凝(OAC)患者。
TT、DT和DAPT在接受PCI-S的OAC患者中的真正疗效和安全性在很大程度上尚不明确。
我们分析了前瞻性多中心华法林与冠状动脉支架置入(WAR-STENT)注册研究(ClinicalTrials.gov标识符NCT00722319)的数据库,仅纳入出院后时期的数据。
在首次住院后存活出院的401例患者中,分别有339例(85%)、20例(5%)和42例(10%)接受了TT、DT和DAPT治疗。在平均368.3±22.8天的随访期间,三个治疗组的主要不良心血管事件(MACE,包括心血管死亡、心肌梗死、再次血管重建、支架血栓形成和血栓栓塞)、总出血、大出血以及MACE加总出血情况具有可比性。TT组大出血的绝对发生率为4%。大出血时实际正在进行的抗血栓治疗中,44%为TT,50%为DT,6%为DAPT。
在WAR-STENT注册研究中接受PCI-S的OAC患者的真实世界人群中,TT、DT和DAPT这三种抗血栓治疗方案显示出相当的疗效和安全性。由于存在若干局限性,我们的数据在反驳目前开具TT的建议方面不能被视为结论性的。需要进一步开展设计合理且规模合适的研究。