Department of Cardiology, INSELSPITAL, Bern University Hospital, University of Bern, Bern 3010, Switzerland.
Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.
Eur Heart J. 2016 Dec 14;37(47):3503-3512. doi: 10.1093/eurheartj/ehw225. Epub 2016 Jul 7.
In view of the currently available evidence from randomized trials, we aimed to compare the collective safety and efficacy of transcatheter aortic valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the spectrum of risk and in important subgroups.
Trials comparing TAVI vs. SAVR were identified through Medline, Embase, and Cochrane databases. The primary outcome was death from any cause at 2 years. We performed random-effects meta-analyses to combine the available evidence and to evaluate the effect in different subgroups. This systematic review and meta-analysis is registered with PROSPERO (CRD42016037273). We identified four eligible trials including 3806 participants, who were randomly assigned to undergo TAVI (n = 1898) or SAVR (n = 1908). For the primary outcome of death from any cause, TAVI when compared with SAVR was associated with a significant 13% relative risk reduction [hazard ratio (95% CI): 0.87 (0.76-0.99); P = 0.038] with homogeneity across all trials irrespective of TAVI device (P = 0.306) and baseline risk (P = 0.610). In subgroup analyses, TAVI showed a robust survival benefit over SAVR for patients undergoing transfemoral access [0.80 (0.69-0.93); P = 0.004], but not transthoracic access [1.17 (0.88-1.56); P = 0.293] (P = 0.024) and in female [0.68 (0.50-0.91); P = 0.010], but not male patients [0.99 (0.77-1.28); P = 0.952] (P = 0.050). Secondary outcomes of kidney injury, new-onset atrial fibrillation, and major bleeding favoured TAVI, while major vascular complications, incidence of permanent pacemaker implantation, and paravalvular regurgitation favoured SAVR.
Compared with SAVR, TAVI is associated with a significant survival benefit throughout 2 years of follow-up. Importantly, this superiority is observed irrespective of the TAVI device across the spectrum of intermediate and high-risk patients, and is particularly pronounced among patients undergoing transfemoral TAVI and in females.
鉴于目前随机试验的证据，我们旨在比较经导管主动脉瓣置换术（TAVI）与外科主动脉瓣置换术（SAVR）在整个风险谱中和重要亚组中的总体安全性和疗效。
通过 Medline、Embase 和 Cochrane 数据库确定了比较 TAVI 与 SAVR 的试验。主要结局为 2 年时的任何原因死亡。我们进行了随机效应荟萃分析，以合并现有证据并评估不同亚组中的效果。本系统评价和荟萃分析已在 PROSPERO（CRD42016037273）注册。我们确定了四项符合条件的试验，共纳入 3806 名参与者，随机分配接受 TAVI（n = 1898）或 SAVR（n = 1908）。对于任何原因死亡的主要结局，与 SAVR 相比，TAVI 与显著降低 13%的相对风险相关[风险比（95%CI）：0.87（0.76-0.99）；P = 0.038]，且所有试验均具有同质性，无论 TAVI 装置如何（P = 0.306）和基线风险如何（P = 0.610）。在亚组分析中，经股动脉入路的患者中，TAVI 显示出比 SAVR 更可靠的生存获益[0.80（0.69-0.93）；P = 0.004]，但经胸入路的患者中则不然[1.17（0.88-1.56）；P = 0.293]（P = 0.024），女性患者中如此[0.68（0.50-0.91）；P = 0.010]，但男性患者中则不然[0.99（0.77-1.28）；P = 0.952]（P = 0.050）。次要结局的肾脏损伤、新发心房颤动和大出血有利于 TAVI，而主要血管并发症、永久性起搏器植入和瓣周漏则有利于 SAVR。
与 SAVR 相比，TAVI 在 2 年随访期间与显著的生存获益相关。重要的是，这种优势在整个中高危患者的范围内无论 TAVI 装置如何均存在，且在经股动脉 TAVI 患者和女性中更为显著。
