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接受PCI的心房颤动患者的出血预防研究
Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI


C. Michael Gibson ... 心脑血管疾病 • 2016.12.22
相关阅读
• 抗凝与抗血小板治疗在心房颤动与冠状动脉介入患者中的应用

心房颤动行经皮冠状动脉介入治疗患者优化抗栓治疗方案的探索
——PIONEER AF-PCI述评

 

王建安

浙江大学医学院附属第二医院

 

心房颤动行经皮冠状动脉介入治疗(PCI)或合并急性冠脉综合征(ACS)的患者在临床上并不少见,行PCI的患者中5%~8%有心房颤动,不同研究报道ACS患者中心房颤动发生率为2%~21% 1。STARS研究告诉我们,第一代支架置入术后阿司匹林加P2Y12抑制剂噻氯匹定(抵克立得)的双重抗血小板治疗(DAPT),在预防支架内血栓上要优于阿司匹林加华法林;而ACTIVE-W研究则告诉我们,华法林在预防心房颤动患者栓塞事件方面要优于阿司匹林加P2Y12抑制剂氯吡格雷2,3。这完全可以从病理生理机制上得到解释:高血流速度的动脉系统原位血栓形成主要为血小板激活所致,而慢血流速度的左房或静脉系统血栓形成主要为凝血机制激活导致。心房颤动行PCI或合并ACS的患者的CHADS2VASC评分至少为1分,有抗凝治疗指征,同时又需要DAPT,这样就有所谓的三联疗法。但是阿司匹林、氯吡格雷加华法林的三联疗法的出血风险较单药治疗显著增加3.7倍4。因此对这部分患者尚缺乏理想的、能够平衡缺血及出血风险的优化抗栓治疗方案。

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摘要


背景

在接受经皮冠状动脉介入(PCI)置入支架的心房颤动(房颤)患者中,采用标准抗凝治疗,即维生素K拮抗剂加P2Y12抑制剂和阿司匹林的双重抗血小板治疗(DAPT),可以减少血栓形成和降低卒中危险,但会增加出血危险。利伐沙班加一种或两种抗血小板药物抗凝的有效性和安全性尚未确定。

 

方法

我们随机分配2,124例接受PCI支架置入的非瓣膜性房颤参与者以1∶1∶1的比例接受以下3种治疗:小剂量利伐沙班(15 mg,每日1次)加一种P2Y12抑制剂治疗12个月(1组);极小剂量利伐沙班(2.5 mg,每日2次)加DAPT治疗1个月、6个月或12个月(2组);剂量调整的维生素K拮抗剂(每日1次)加DAPT治疗1个月、6个月或12个月的标准疗法(3组)。主要安全性结局为有临床意义的出血(根据心肌梗死溶栓[Thrombolysis in Myocardial Infarction,TIMI]标准判定的大出血或轻微出血,或需要医疗关注的出血)。

 

结果

在接受利伐沙班治疗的两组中,有临床意义的出血发生率低于标准疗法组(1组为16.8%,2组为18.0%,3组为26.7%;1组对3组的风险比为0.59;95%可信区间[CI]为0.47~0.76;P<0.001;2组对3组的风险比为0.63;95% CI为0.50~0.80;P<0.001)。心血管原因死亡、心肌梗死或卒中的发生率在三组中相似(Kaplan-Meier估计值,1组为6.5%,2组为5.6%,3组为6.0%;所有比较P值均无显著性)。

 

结论

在接受PCI支架置入的房颤参与者中,与给予维生素K拮抗剂加DAPT标准疗法1个月、6个月或12个月相比,给予小剂量利伐沙班加P2Y12抑制剂治疗12个月或极小剂量利伐沙班加DAPT治疗1个月、6个月或12个月与有临床意义的出血发生率较低相关。尽管观察到的宽可信区间减弱了任何关于疗效结论的确定性,但三组间具有相似的有效率(由杨森制药科学事务部[Janssen Scientific Affairs]和拜耳制药[Bayer Pharmaceuticals]资助;PIONEER AF-PCI在ClinicalTrials.gov注册号为NCT01830543)。





作者信息

C. Michael Gibson, M.D., Roxana Mehran, M.D., Christoph Bode, M.D., Jonathan Halperin, M.D., Freek W. Verheugt, M.D., Peter Wildgoose, Ph.D., Mary Birmingham, Pharm.D., Juliana Ianus, Ph.D., Paul Burton, M.D., Ph.D., Martin van Eickels, M.D., Serge Korjian, M.D., Yazan Daaboul, M.D., Gregory Y.H. Lip, M.D., Marc Cohen, M.D., Steen Husted, M.D., Eric D. Peterson, M.D., M.P.H., and Keith A. Fox, M.B., Ch.B.
From the Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston (C.M.G., S.K., Y.D.); the Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M., J.H.); Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg (C.B.), and Bayer Pharmaceuticals, Leverkusen (M.E.) — both in Germany; Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam (F.W.V.); Janssen Pharmaceuticals, Titusville (P.W., M.B., J.I., P.B.), and the Division of Cardiology, Newark Beth Israel Medical Center, Newark (M.C.) — both in New Jersey; University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, United Kingdom (G.Y.H.L.); Aarhus University Hospital, Medical Department, Hospital Unit West, Herning, Denmark (S.H.); Duke Clinical Research Institute, Durham, NC (E.D.P.); and the Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh (K.A.F.). Address reprint requests to Dr. Gibson at Harvard Medical School, Beth Israel Deaconess Medical Center, 330 Brookline Ave., Overland 540, Boston, MA 02215, or at mgibson@bidmc.harvard.edu.

 

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