Department of Medicine, West Virginia University, Morgantown, West Virginia.
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
Am J Cardiol. 2019 Nov 15;124(10):1608-1614. doi: 10.1016/j.amjcard.2019.07.066. Epub 2019 Aug 22.
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.
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。