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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
Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation


Vincent J. Nijenhuis ... 心脑血管疾病 • 2020.04.30
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摘要


背景

经导管主动脉瓣植入术(TAVI)后单独抗凝或抗凝联合抗血小板药的作用尚未经过充分研究。

 

方法

我们在因适当适应证接受口服抗凝治疗的TAVI患者中对氯吡格雷开展了一项随机试验。我们在TAVI术前以1∶1的比例将患者随机分组,一组不接受氯吡格雷治疗,另一组接受氯吡格雷治疗3个月。两项主要结局是12个月期间的全部出血和手术不相关出血。手术相关出血的定义为出血学术研究联合会(Bleeding Academic Research Consortium)4型重度出血,因此穿刺部位的大多数出血被视为手术不相关出血。两项次要结局分别是由12个月时的心血管原因死亡、手术不相关出血、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),我们对两项次要结局均进行了非劣效性(非劣效性界值,7.5个百分点)和优效性检验。

 

结果

接受单独口服抗凝治疗的157例患者中的34例(21.7%)和接受口服抗凝+氯吡格雷治疗的156例患者中的54例(34.6%)发生了出血(危险比,0.63;95%置信区间[CI],0.43~0.90;P=0.01);大多数出血事件发生在TAVI入路部位。两组分别有34例患者(21.7%)和53例患者(34.0%)发生了手术不相关出血(危险比,0.64;95% CI,0.44~0.92;P=0.02)。大多数出血发生在第一个月,属于小出血。接受单独口服抗凝治疗的49例患者(31.2%)和接受口服抗凝+氯吡格雷治疗的71例患者(45.5%)发生了次要复合结局1事件(差异,-14.3个百分点;非劣效性95% CI,-25.0~-3.6;危险比,0.69;优效性95% CI,0.51~0.92)。分别有21例患者(13.4%)和27例患者(17.3%)发生了次要复合结局2事件(差异,-3.9个百分点;非劣效性95% CI,-11.9~4.0;危险比,0.77;优效性95% CI,0.46~1.31)。

 

结论

在接受口服抗凝治疗的TAVI患者中,单独口服抗凝组在1个月或1年期间的严重出血发生率低于口服抗凝+氯吡格雷治疗组(由荷兰健康研究和开发组织[Netherlands Organization for Health Research and Development]资助,POPular TAVI的EU临床试验注册系统注册号为2013-003125-28,在ClinicalTrials.gov注册号为NCT02247128)。





作者信息

Vincent J. Nijenhuis, M.D., Jorn Brouwer, 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 (V.J.N., J. Brouwer, 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 Centers, Location AMC, Amsterdam (R.D., J. Baan), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H.), the Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute, Maastricht (W.H., L.V., A.W.J.H.), 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.), the Department of Cardiology, Onze Lieve Vrouwe Hospital (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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