WOEST结果可指导PCI患者的抗血栓治疗
科罗拉多州斯诺马斯——关于如何在接受经皮冠状动脉血管重建伴支架置入、需要使用口服抗凝药物的急性冠脉综合征患者中管理抗血栓治疗,近期一项随机试验——WOEST——向临床医生提供了重要的新指导
美国心脏病学会(ACC)候任主席、哈佛医学院布里格姆妇女医院临床心脏科主任Patrick T. O’Gara医生在斯诺马斯心血管会议上评论称:“我认为这是去年心血管领域最重要的试验之一。”
WOEST是一项荷兰/比利时的多中心、随机、开放标记研究,在这项研究中,573例此类患者被分为三联抗血栓治疗组(在华法林的基础上加用氯吡咯雷和阿司匹林)和二联治疗组(华法林加氯吡咯雷)。
该研究的主要终点是支架置入术后1年内的出血率。结果显示,二联治疗组的出血率为19.4%,而三联治疗组为44.4%,即较不积极的抗血栓治疗使出血率相对降低了64%。二联治疗组有3.9%的患者在随访期间至少需要1次输血,而三联治疗组的这一比例为9.5%(Lancet 2013;381:1107-15)。
“三联治疗与二联治疗相比,出血风险增加2倍以上,这一结果并不令人意外。让我吃惊的是,在次要终点方面——死亡/心肌梗死/卒中/靶血管重建/支架血栓,也是三联治疗组更高。”
事实上,三联治疗组的这一复合终点发生率为17.6%,而二联治疗组仅为11.1%,后者的相对风险降低了40%。
“这项研究提示,在置入支架后使用氯吡咯雷和一种维生素K拮抗剂不仅更安全,而且实际上可能比三联抗血栓治疗更有效。当然,这一点还有待进一步研究证实,而且本项研究的样本量相对较小,不过它已为将来的试验设置了标准,而且已经能对临床决策产生一定影响了。我认为,该研究提示,在PCI(经皮冠状动脉介入治疗)后使用氯吡咯雷加华法林是一种适用性较强的策略,尤其是对于那些复发卒中风险相对较低的患者。”
作为ACC/美国心脏协会(AHA)STEMI指南编撰委员会的主席,O’Gara医生表示该委员会将在今年春季的2013年版指南修订会议上详细探讨WOEST。
WOEST获得了荷兰和比利时研究基金会的资助。O’Gara医生报告称无相关利益冲突。
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By: BRUCE JANCIN, Cardiology News Digital Network
SNOWMASS, COLO. – A recent randomized trial provides physicians with important new guidance on how to manage antithrombotic therapy in patients requiring oral anticoagulation who develop an acute coronary syndrome and undergo percutaneous coronary revascularization with stent implantation.
"I think this is one of the most important trials in cardiology published last year. I think it has to rank in the top five," Dr. Patrick T. O’Gara commented at the Annual Cardiovascular Conference at Snowmass.
The trial is WOEST, a Dutch/Belgian multicenter, randomized, open-label study in which 573 such patients were assigned to triple antithrombotic therapy with clopidogrel and aspirin on top of their background warfarin, or to dual therapy with warfarin and clopidogrel.
The primary outcome was the rate of bleeding during the first year following stent implantation. The rate was 19.4% in patients on double therapy and 44.4% in those on triple therapy, for a highly significant 64% reduction in relative risk favoring the less aggressive antithrombotic strategy. At least one blood transfusion was required during the follow-up period by 3.9% of patients receiving dual therapy, compared with 9.5% of patients on triple therapy (Lancet 2013;381:1107-15).
"The more than twofold excess risk of bleeding in patients treated with triple versus double antithrombotic therapy is not a surprise. What was a surprise in this particular study was that a secondary endpoint of death/MI/stroke/target vessel revascularization/stent thrombosis was also higher in the triple-therapy group," said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.
Indeed, the rate of this composite endpoint was 17.6% with triple therapy, compared with 11.1% with double therapy, for a 40% relative risk reduction.
"This study implies that the use of clopidogrel and a vitamin K antagonist is not only safer but actually might be more efficacious than a strategy of triple antithrombotic therapy following stent deployment," observed Dr. O’Gara, the American College of Cardiology (ACC) president-elect.
"Obviously this will need to be validated in other groups, and the sample size here is relatively small at under 600 patients, but this study has set the standard against which we need to design future trials and begin to make some clinical decisions. I think this gives us a great deal of cover with the use of clopidogrel plus warfarin after PCI [percutaneous coronary intervention] in patients, particularly in those in whom you think the risk of recurrent stroke is relatively low," according to the cardiologist.
Dr. O’Gara, who chairs the ACC/American Heart Association STEMI Guideline Writing Committee, predicted the committee will take a close look at WOEST when it meets this spring to adjudicate revisions in the 2013 guidelines.
WOEST was funded by Dutch and Belgian research foundations. Dr. O’Gara reported having no financial conflicts.
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