Sardar Partha, Kundu Amartya, Chatterjee Saurav, Feldman Dmitriy N, Owan Theophilus, Kakouros Nikolaos, Nairooz Ramez, Pape Linda A, Feldman Ted, Dawn Abbott J, Elmariah Sammy
Division of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.
Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
Catheter Cardiovasc Interv. 2017 Sep 1;90(3):504-515. doi: 10.1002/ccd.27041. Epub 2017 Apr 11.
We performed a meta-analysis to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) in intermediate-risk patients.
TAVR is an established treatment option in high-risk patients with severe aortic valve stenosis (AS). There are fewer data regarding efficacy of TAVR in intermediate-risk patients.
Databases were searched through April 30, 2016 for studies that compared TAVR with SAVR for the treatment of intermediate-risk patients with severe AS. We calculated summary risk ratios (RRs) and 95% confidence intervals (CIs) with the random-effects model.
The analysis included 4,601 patients from 7 studies (2 randomized and 5 observational). There was no significant difference in all-cause mortality between the two groups after mean follow-up of 1.15 years [14.7% with TAVR vs 15.4% with SAVR; RR 0.93; 95% CI 0.77-1.12]. TAVR resulted in lower rates of acute kidney injury [number needed to treat (NNT) = 26], major bleeding (NNT = 4), and atrial-fibrillation (NNT = 6), but higher rates of major vascular complications [number needed to harm (NNH)= 18], and moderate/severe aortic regurgitation (NNH = 13). The rate of permanent-pacemaker implantation was significantly higher with TAVR in observational studies (RR 2.31; 95% CI 1.22-2.81), but not in RCTs (RR 1.21; 95% CI 0.93-1.56). No significant difference in the rate of stroke or myocardial infarction was observed.
Our analysis of mid-term results showed that TAVR has similar clinical efficacy to SAVR in intermediate-risk patients with severe AS, and can be a suitable alternative to surgical valve replacement. © 2017 Wiley Periodicals, Inc.
我们进行了一项荟萃分析，以评估经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术（SAVR）相比，在中度风险患者中的疗效和安全性。
TAVR是重度主动脉瓣狭窄（AS）高危患者的既定治疗选择。关于TAVR在中度风险患者中的疗效数据较少。
检索截至2016年4月30日的数据库，查找比较TAVR与SAVR治疗中度风险重度AS患者的研究。我们采用随机效应模型计算汇总风险比（RRs）和95%置信区间（CIs）。
分析纳入了来自7项研究（2项随机对照试验和5项观察性研究）的4601例患者。平均随访1.15年后，两组全因死亡率无显著差异[接受TAVR的患者为14.7%，接受SAVR的患者为15.4%；RR 0.93；95% CI 0.77 - 1.12]。TAVR导致急性肾损伤发生率较低[需治疗人数（NNT）= 26]、大出血发生率较低（NNT = 4）和心房颤动发生率较低（NNT = 6），但主要血管并发症发生率较高[需伤害人数（NNH）= 18]，以及中度/重度主动脉瓣关闭不全发生率较高（NNH = 13）。在观察性研究中，TAVR的永久起搏器植入率显著更高（RR 2.31；95% CI 1.22 - 2.81），但在随机对照试验中并非如此（RR 1.21；95% CI 0.93 - 1.56）。未观察到卒中或心肌梗死发生率的显著差异。
我们对中期结果的分析表明，在中度风险重度AS患者中，TAVR与SAVR具有相似的临床疗效，并且可以作为外科瓣膜置换的合适替代方案。© 2017威利期刊公司。
