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心力衰竭患者的经导管二尖瓣修复术
Transcatheter Mitral-Valve Repair in Patients with Heart Failure


Gregg W. Stone ... 心脑血管疾病 • 2018.12.13
相关阅读
• 2017心脏瓣膜病治疗方案要点更新 • 治疗心力衰竭,经导管二尖瓣修复术优于药物治疗

摘要


背景

因左心室功能障碍出现二尖瓣反流的心力衰竭患者预后不良。经导管二尖瓣修复术可能改善这些患者的临床结局。

 

方法

在美国和加拿大的78家研究中心,我们纳入了虽然接受指南指导的最大剂量药物治疗,但仍有症状,患中至重度或重度继发性二尖瓣反流的心力衰竭患者。我们将患者随机分组,接受经导管二尖瓣修复术+药物治疗(器械组)或单独药物治疗(对照组)。主要疗效终点为24个月随访期间的所有因心力衰竭住院治疗。主要安全性终点为12个月时无器械相关并发症;将这一终点的发生率与预设客观性能目标88.0%进行了比较。

 

结果

在本试验纳入的614例患者中,302例被分配至器械组,312例被分配至对照组。在器械组和对照组中,24个月内所有因心力衰竭住院治疗的年发生率分别为35.8%/患者-年和67.9%/患者-年(风险比,0.53;95%置信区间[CI],0.40~0.70;P<0.001)。12个月时无器械相关并发症的比例为96.6%(95% CI下限,94.8%;与性能目标的比较,P<0.001)。在器械组和对照组中,24个月内的全因死亡率分别为29.1%和46.1%(风险比,0.62;95% CI,0.46~0.82;P<0.001)。

 

结论

在虽然接受指南指导的最大剂量药物治疗,但仍有症状,患中至重度或重度继发性二尖瓣反流的心力衰竭患者中,在24个月随访期间,与单独药物治疗相比,经导管二尖瓣修复术获得了较低的心力衰竭住院率和全因死亡率。无器械相关并发症的比例超过预设的安全性阈值(由雅培资助;COAPT在ClinicalTrials.gov注册号为NCT01626079)。





作者信息

Gregg W. Stone, M.D., JoAnn Lindenfeld, M.D., William T. Abraham, M.D., Saibal Kar, M.D., D. Scott Lim, M.D., Jacob M. Mishell, M.D., Brian Whisenant, M.D., Paul A. Grayburn, M.D., Michael Rinaldi, M.D., Samir R. Kapadia, M.D., Vivek Rajagopal, M.D., Ian J. Sarembock, M.B., Ch.B., M.D., Andreas Brieke, M.D., Steven O. Marx, M.D., David J. Cohen, M.D., Neil J. Weissman, M.D., and Michael J. Mack, M.D. for the COAPT Investigators*
From New York–Presbyterian Hospital and the Cardiovascular Research Foundation (G.W.S.) and Columbia University Medical Center (G.W.S., S.O.M.), New York; Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville (J.L.); the Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart and Lung Research Institute, Ohio State University, Columbus (W.T.A.), the Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland (S.R.K.), and Christ Hospital, Cincinnati (I.J.S.) — all in Ohio; Smidt Heart Institute, Cedars–Sinai Medical Center, Los Angeles (S.K.), and Kaiser Permanente–San Francisco Hospital, San Francisco (J.M.M.) — both in California; the Division of Cardiology, University of Virginia, Charlottesville (D.S.L.); Intermountain Medical Center, Murray, UT (B.W.); Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas (P.A.G.), and Baylor Scott and White Heart Hospital Plano, Plano (M.J.M.) — both in Texas; Carolinas Medical Center, Charlotte, NC (M.R.); Piedmont Hospital, Atlanta (V.R.); University of Colorado Hospital, Aurora (A.B.); Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City School of Medicine, Kansas City (D.J.C.); and MedStar Health Research Institute, Hyattsville, MD (N.J.W.). Address reprint requests to Dr. Stone at Columbia University Medical Center, Cardiovascular Research Foundation, 1700 Broadway, 8th Fl., New York, NY 10019, or at gs2184@columbia.edu. *A list of investigators, institutions, and research organizations participating in the COAPT trial is provided in the Supplementary Appendix, available at NEJM.org.

 

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