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经导管主动脉瓣置换术与外科主动脉瓣置换术术后结局的时间和手术风险相关的荟萃分析。

Meta-analysis of Temporal and Surgical Risk Dependent Associations With Outcomes After Transcatheter Versus Surgical Aortic Valve Implantation.

机构信息

Department of Medicine, West Virginia University, Morgantown, West Virginia.

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.

出版信息

Am J Cardiol. 2019 Nov 15;124(10):1608-1614. doi: 10.1016/j.amjcard.2019.07.066. Epub 2019 Aug 22.

Abstract

Temporal and surgical risk dependent associations with clinical outcomes in patients receiving transcatheter versus surgical aortic valve implantation (TAVI vs SAVI) are uncertain. In this meta-analysis, 7 randomized controlled trials (7,771 patients) were included to investigate trends in outcomes in TAVI versus SAVI up to 5 years, and variation in outcomes with respect to low-, intermediate-, and high-surgical risk of the patients up to 1 year. Estimates were calculated as random effects hazard ratios (HRs) with 95% confidence intervals (CI). All-cause mortality was similar in TAVI and SAVI at 30 days (HR 0.81, 95% CI 0.55 to 1.21, p = 0.31), 1 year (HR 0.97, 95% CI 0.89 to 1.06, p = 0.49), 2 years (HR 0.96, 95 CI 0.85 to 1.09, p = 0.54), and 5 years (HR 1.04, 95% CI 0.89 to 1.21, p = 0.62). Cardiac mortality, myocardial infarction and stroke were similar in both interventions up to 5 years. TAVI was associated with lower risk of atrial fibrillation, but higher risk of vascular complications, pacemaker implantation, and paravalvular leak up to 5 years. The lower risks of major bleeding and acute kidney injury with TAVI versus SAVI were limited to 1 and 2 years, respectively. Compared with SAVI, TAVI was superior in reducing all-cause mortality in low surgical risk patients at 30 days only, whereas TAVI was noninferior to SAVI in intermediate- and high-risk patients at 30 days and across all risks at 1 year. In conclusion, TAVI was noninferior to SAVI in terms of mortality, myocardial infarction, and stroke up to 5 years. TAVI improved survival versus SAVI in low-risk patients at 30 days.

摘要

在接受经导管主动脉瓣置换术(TAVI)与外科主动脉瓣置换术(SAVI)的患者中,时间和手术风险相关的临床结局关联尚不确定。在这项荟萃分析中,纳入了 7 项随机对照试验(7771 名患者),旨在调查 TAVI 与 SAVI 相比,在 5 年内的结局趋势,以及在 1 年内,患者的低、中、高手术风险与结局的变化关系。采用随机效应风险比(HR)和 95%置信区间(CI)进行评估。TAVI 与 SAVI 在 30 天(HR 0.81,95%CI 0.55 至 1.21,p=0.31)、1 年(HR 0.97,95%CI 0.89 至 1.06,p=0.49)、2 年(HR 0.96,95%CI 0.85 至 1.09,p=0.54)和 5 年(HR 1.04,95%CI 0.89 至 1.21,p=0.62)时的全因死亡率相似。两种干预措施在 5 年内的心脏死亡率、心肌梗死和中风发生率相似。TAVI 与较低的心房颤动风险相关,但与血管并发症、起搏器植入和瓣周漏相关的风险较高,持续至 5 年。与 SAVI 相比,TAVI 在 1 年和 2 年时分别降低了大出血和急性肾损伤的风险。与 SAVI 相比,TAVI 在 30 天时仅降低了低手术风险患者的全因死亡率,而在 30 天时和 1 年时,TAVI 在中危和高危患者中不劣于 SAVI。总之,在 5 年内,TAVI 在死亡率、心肌梗死和中风方面不劣于 SAVI。在 30 天时,TAVI 与 SAVI 相比,改善了低危患者的生存。

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