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球扩式瓣膜经导管主动脉瓣置换术用于低风险患者
Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients


Michael J. Mack ... 心脑血管疾病 • 2019.05.02
相关阅读
• 经导管主动脉瓣置换术治疗无手术指征的严重主动脉瓣狭窄 • 外科或经导管主动脉瓣置换术治疗中危患者 • 对于外科手术中危的重度主动脉瓣狭窄患者应选用TAVR还是外科手术?

摘要


背景

在手术死亡风险中或高的主动脉瓣狭窄患者中,经导管主动脉瓣置换术(TAVR)和外科主动脉瓣置换术的主要结局相似。两种手术在低风险患者中的比较尚无充分证据。

 

方法

我们将手术风险低的重度主动脉瓣狭窄患者随机分组,分别接受经股动脉入路球扩式瓣膜TAVR或接受外科手术。主要终点是1年时死亡、卒中或再次住院构成的复合终点。在实际治疗人群(as-treated population)中进行了非劣效性检验(预设界值为6个百分点)和优效性检验。

 

结果

1,000例患者在71个中心接受了随机分组。患者平均年龄为73岁,美国胸外科医师学会(Society of Thoracic Surgeons)平均风险评分为1.9%(评分范围是0~100%,较高评分表明术后30日内较高死亡风险)。TAVR组1年时主要复合终点发生率的Kaplan-Meier估计值显著低于外科手术组(8.5% vs. 15.1%;绝对差异,-6.6个百分点;95%置信区间[CI],-10.8~-2.5;非劣效性P<0.001;风险比,0.54;95% CI,0.37~0.79;优效性P=0.001)。30日时,与外科手术相比,TAVR使患者达到较低的卒中发生率(P=0.02)、较低的死亡或卒中发生率(P=0.01)以及较低的新发心房颤动发生率(P<0.001)。30日时,与外科手术相比,TAVR还使患者达到较短的首次住院时间(P<0.001),以及较低的不良结局(死亡或堪萨斯城心肌病问卷[Kansas City Cardiomyopathy Questionnaire]评分低)发生风险(P<0.001)。在主要血管并发症、植入新的永久性起搏器或者中或重度瓣周反流方面无显著组间差异。

 

结论

在手术风险低的重度主动脉瓣狭窄患者中,TAVR组1年时复合终点(死亡、卒中或再次住院)的发生率显著低于外科手术组(由爱德华生命科学公司[Edwards Lifesciences]资助;PARTNER 3在ClinicalTrials.gov注册号为NCT02675114)。





作者信息

Michael J. Mack, M.D., Martin B. Leon, M.D., Vinod H. Thourani, M.D., Raj Makkar, M.D., Susheel K. Kodali, M.D., Mark Russo, M.D., Samir R. Kapadia, M.D., S. Chris Malaisrie, M.D., David J. Cohen, M.D., Philippe Pibarot, D.V.M., Ph.D., Jonathon Leipsic, M.D., Rebecca T. Hahn, M.D., Philipp Blanke, M.D., Mathew R. Williams, M.D., James M. McCabe, M.D., David L. Brown, M.D., Vasilis Babaliaros, M.D., Scott Goldman, M.D., Wilson Y. Szeto, M.D., Philippe Genereux, M.D., Ashish Pershad, M.D., Stuart J. Pocock, Ph.D., Maria C. Alu, M.S., John G. Webb, M.D., and Craig R. Smith, M.D. for the PARTNER 3 Investigators*
From Baylor Scott and White Health, Plano, TX (M.J.M., D.L.B.); Columbia University Irving Medical Center and New York–Presbyterian Hospital (M.B.L., S.K.K., R.T.H., M.C.A., C.R.S.) and New York University Langone Medical Center (M.R.W.) — both in New York; Medstar Heart and Vascular Institute, Georgetown University, Washington, DC (V.H.T.); Cedars–Sinai Heart Institute, Los Angeles (R.M.); Robert Wood Johnson Medical School, Rutgers University, New Brunswick (M.R.), and Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown (P.G.) — both in New Jersey; Cleveland Clinic, Cleveland (S.R.K.); Feinberg School of Medicine, Northwestern University, Chicago (S.C.M.); Saint Luke’s Mid America Heart Institute, Kansas City, MO (D.J.C.); Quebec Heart and Lung Institute, Laval University, Quebec, QC (P.P.), and St. Paul’s Hospital, University of British Columbia, Vancouver (J.L., P.B., J.G.W.) — both in Canada; University of Washington, Seattle (J.M.M.); Emory University Hospital, Atlanta (V.B.); Lankenau Medical Center, Wynnewood (S.G.), and the Hospital of the University of Pennsylvania, Philadelphia (W.Y.S.) — both in Pennsylvania; Banner University Medical Center, Phoenix, AZ (A.P.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.). Address reprint requests to Dr. Mack at Baylor Scott and White Health Heart Hospital–Plano, 1100 Allied Dr., Plano, TX 75093, or at michael.mack@bswhealth.org. *A complete list of the PARTNER 3 Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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