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经导管主动脉瓣植入术后阿司匹林联合与不联合氯吡格雷的比较
Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation


Jorn Brouwer ... 心脑血管疾病 • 2020.10.08
相关阅读
• 经导管主动脉瓣植入术后应用和不应用氯吡格雷的抗凝治疗比较 • 经导管主动脉瓣置换术后应用利伐沙班的对照试验

TAVI后抗栓治疗的奥卡姆剃刀定律

 

叶晓峰,赵强*

上海交通大学医学院附属瑞金医院心血管外科

*通讯作者

 

TAVI后单抗优于双抗的进一步证实

本质上讲,POPular TAVI1的结果符合药理学逻辑。就出血事件而言,单药抗血小板治疗组(SAPT,即持续单用阿司匹林80~100 mg/d治疗)要显著少于双联抗血小板治疗组(DAPT,即阿司匹林80~100 mg/d+氯吡格雷75 mg/d治疗3个月,随后持续单用阿司匹林80~100 mg/d治疗)1

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摘要


背景

无长期抗凝治疗适应证的患者接受经导管主动脉瓣植入术(TAVI)后,单药和双联抗血小板治疗对出血和血栓栓塞事件的影响尚未经过充分研究。

 

方法

在一项随机对照试验中,我们将正在接受TAVI且并无长期抗凝治疗适应证的患者以1∶1比例随机分组,两组分别接受为期3个月的阿司匹林单药治疗或阿司匹林联合氯吡格雷治疗。两项主要结局是12个月期间的所有出血(包括小出血、大出血,以及危及生命或致残性出血)和非手术相关出血。TAVI穿刺部位的大部分出血被视为非手术相关出血。两项次要结局是1年时由心血管原因死亡、非手术相关出血、卒中或心肌梗死构成的复合结局(次要复合结局1),以及由心血管原因死亡、缺血性卒中或心肌梗死构成的复合结局(次要复合结局2),两项结局依次进行非劣效性(非劣效性界值,7.5个百分点)和优效性检验。

 

结果

共计331例患者被分配接受阿司匹林单药治疗,334例患者被分配接受阿司匹林联合氯吡格雷治疗。阿司匹林组和阿司匹林联合氯吡格雷组分别有50例患者(15.1%)和89例患者(26.6%)发生了出血事件(危险比,0.57;95%置信区间[CI],0.42~0.77;P=0.001)。两组分别有50例患者(15.1%)和83例患者(24.9%)发生了非手术相关出血(危险比,0.61;95% CI,0.44~0.83;P=0.005)。阿司匹林组和阿司匹林联合氯吡格雷组分别有76例患者(23.0%)和104例患者(31.1%)发生了次要复合结局1事件(差异,-8.2个百分点;非劣效性的95% CI,-14.9~-1.5;P<0.001;危险比,0.74;优效性的95% CI,0.57~0.95;P=0.04)。两组分别有32例患者(9.7%)和33例患者(9.9%)发生了次要复合结局2事件(差异,-0.2个百分点;非劣效性的95% CI,-4.7~4.3;P=0.004;危险比,0.98;优效性的95% CI,0.62~1.55;P=0.93)。两组分别有44例患者(13.3%)和32例患者(9.6%)在试验期间接受了口服抗凝治疗。

 

结论

在接受TAVI治疗且无口服抗凝治疗适应证患者中,为期3个月的阿司匹林单药治疗与阿司匹林联合氯吡格雷治疗相比,1年时前者出血发生率和复合结局(出血或血栓栓塞事件)发生率均显著较低(由荷兰卫生研究与发展组织[Netherlands Organization for Health Research and Development]资助,POPular TAVI在欧盟临床试验注册系统[EU Clinical Trials Register]注册号为2013-003125-28,在ClinicalTrials.gov注册号为NCT02247128)。





作者信息

Jorn Brouwer, M.D., Vincent J. Nijenhuis, M.D., Ronak Delewi, M.D., Ph.D., Renicus S. Hermanides, M.D., Ph.D., Wouter Holvoet, M.D., Christophe L.F. Dubois, M.D., Ph.D., Peter Frambach, M.D., Bernard De Bruyne, M.D., Ph.D., Gert K. van Houwelingen, M.D., Jan A.S. Van Der Heyden, M.D., Ph.D., Petr Toušek, M.D., Ph.D., Frank van der Kley, M.D., Ian Buysschaert, M.D., Ph.D., Carl E. Schotborgh, M.D., Bert Ferdinande, M.D., Pim van der Harst, M.D., Ph.D., John Roosen, M.D., Joyce Peper, M.Sc., Frederick W.F. Thielen, M.Sc., Leo Veenstra, M.D., Dean R.P.P. Chan Pin Yin, M.D., Martin J. Swaans, M.D., Ph.D., Benno J.W.M. Rensing, M.D., Ph.D., Arnoud W.J. van ’t Hof, M.D., Ph.D., Leo Timmers, M.D., Ph.D., Johannes C. Kelder, M.D., Ph.D., Pieter R. Stella, M.D., Ph.D., Jan Baan, M.D., Ph.D., and Jurriën M. ten Berg, M.D., Ph.D.
From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (J. Brouwer, V.J.N., J.P., D.R.P.P.C.P.Y., M.J.S., B.J.W.M.R., L.T., J.C.K., J.M.B.), the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center (W.H., L.V., A.W.J.H.) and the Cardiovascular Research Institute Maastricht (A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Medisch Spectrum Twente, Enschede (G.K.H.), the Department of Cardiology, Leiden University Medical Center, Leiden (F.K.), the Department of Cardiology, Haga Hospital, The Hague (C.E.S.), the Department of Cardiology, University Medical Center Groningen, Groningen (P.H.), Erasmus School of Health Policy and Management, Erasmus University, Rotterdam (F.W.F.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen (A.W.J.H.), and the Department of Cardiology, Division of Heart and Lungs, University Medical Center Utrecht, Utrecht University, Utrecht (P.R.S.) — all in the Netherlands; the Department of Cardiology, University Hospital Leuven, Leuven (C.L.F.D.), Cardiovascular Center Aalst, Onze Lieve Vrouwe Clinic (B.D.B.), and the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (I.B.), Aalst, the Department of Cardiology, Sint-Jan Hospital, Brugge (J.A.S.V.D.H.), the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.), and the Department of Cardiology, Imelda Hospital, Bonheiden (J.R.) — all in Belgium; the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg, Luxembourg (P.F.); and the Department of Cardiology, University Hospital Královské Vinohrady and Third Medical Faculty, Charles University, Prague, Czech Republic (P.T.). Address reprint requests to Dr. ten Berg at St. Antonius Hospital, Koekoekslaan 1, 3435CM, Nieuwegein, the Netherlands, or at jurtenberg@gmail.com.

 

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