Takagi H, Hari Y, Nakashima K, Kuno T, Ando T
Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan.
Department of Cardiovascular Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
Neth Heart J. 2020 Jun;28(6):320-333. doi: 10.1007/s12471-020-01378-1.
To determine whether transcatheter aortic valve implantation (TAVI) improves early (30-day) and midterm (1-year) mortality compared with surgical aortic valve replacement (SAVR), we performed an updated meta-analysis of all the currently available randomised controlled trials (RCTs).
To identify all RCTs providing both 30-day and 1‑year mortality after TAVI versus SAVR, PubMed and ClinicalTrials.gov were searched up to and including July 2019. A risk difference (RD) and its 95% confidence interval were generated using data of prespecified outcomes in both the TAVI and SAVR groups. Study-specific estimates were pooled using inverse variance-weighted averages of RDs in the random-effects model.
We identified seven eligible high-quality RCTs including a total of 7631 as-treated patients. Pooled analyses demonstrated significantly lower 30-day (RD -0.60%; p = 0.046) and 1‑year all-cause mortality (RD -1.12%; p = 0.03) after TAVI than after SAVR. No funnel plot asymmetry was detected for 30-day and 1‑year mortality. Meta-regression analyses indicated that RDs of 30-day and 1‑year mortality between TAVI and SAVR were not modulated by mean Society of Thoracic Surgeons Predicted Risk of Mortality score. Bleeding complications at 30 days and 1 year and stage 2/3 acute kidney injury at 30 days were significantly less frequent after TAVI than after SAVR, whereas major vascular complications and new permanent pacemaker implantation at 30 days and 1 year were significantly more frequent after TAVI than after SAVR.
The best evidence from the present meta-analysis of all the currently available RCTs suggests that TAVI may reduce 30-day and 1‑year all-cause mortality compared with SAVR.
为了确定经导管主动脉瓣植入术（TAVI）与外科主动脉瓣置换术（SAVR）相比是否能改善早期（30天）和中期（1年）死亡率，我们对所有现有的随机对照试验（RCT）进行了更新的荟萃分析。
为了识别所有提供TAVI与SAVR术后30天和1年死亡率的RCT，检索了截至2019年7月的PubMed和ClinicalTrials.gov。使用TAVI组和SAVR组中预先设定结局的数据生成风险差异（RD）及其95%置信区间。在随机效应模型中，使用RD的逆方差加权平均值汇总各研究的估计值。
我们确定了7项符合条件的高质量RCT，共纳入7631例接受治疗的患者。汇总分析表明，TAVI术后30天（RD -0.60%；p = 0.046）和1年全因死亡率（RD -1.12%；p = 0.03）显著低于SAVR术后。未检测到30天和1年死亡率的漏斗图不对称性。荟萃回归分析表明，TAVI与SAVR之间30天和1年死亡率的RD不受胸外科医师协会平均预测死亡风险评分的影响。TAVI术后30天和1年的出血并发症以及30天的2/3期急性肾损伤的发生率显著低于SAVR术后，而TAVI术后30天和1年的主要血管并发症和新的永久性起搏器植入的发生率显著高于SAVR术后。
本次对所有现有RCT的荟萃分析的最佳证据表明，与SAVR相比，TAVI可能降低30天和1年全因死亡率。
