Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University.
Division of Cardiology, Kokura Memorial Hospital.
Circ J. 2020 Apr 24;84(5):806-814. doi: 10.1253/circj.CJ-19-0951. Epub 2020 Feb 1.
There are no data comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) outcomes in real clinical practice in Japan.
We combined 2 independent registries, the K-TAVI Registry (a 6-center prospective registry of consecutive patients who underwent TAVI) and the CURRENT AS Registry (a large, 27-center registry of 3,815 consecutive patients with severe aortic stenosis [AS]). In the K-TAVI Registry, 338 patients underwent TAVI with SAPIEN XT balloon-expandable valves from October 2013 to January 2016, whereas in the CURRENT AS Registry 237 patients with severe AS underwent SAVR from January 2003 to December 2011. Propensity score matching was conducted, with final cohort comprising 306 patients. The cumulative 2-year incidence of all-cause death and heart failure (HF) hospitalization did not differ significantly between the TAVI and SAVR groups (13.7% vs. 12.4% [P=0.81] and 7.9% vs 3.9% [P=0.13], respectively). After adjusting for residual confounders, there were no significant differences between the TAVI and SAVR groups in the risk for all-cause death (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.35-1.58; P=0.43) or HF hospitalization (HR 1.27; 95% CI 0.40-4.59; P=0.69).
These findings from 2 independent Japanese registries suggest that the 2-year risk of all-cause mortality and HF does not differ significantly between TAVI and SAVR groups in real-world practice in Japan.
在日本的实际临床实践中,尚无比较经导管主动脉瓣植入术(TAVI)与外科主动脉瓣置换术(SAVR)结果的相关数据。
我们合并了 2 个独立的注册中心,即 K-TAVI 注册中心(一个连续接受 TAVI 治疗的 6 个中心前瞻性注册中心)和 CURRENT AS 注册中心(一个包含 3815 例严重主动脉瓣狭窄患者的大型 27 个中心注册中心)。在 K-TAVI 注册中心,2013 年 10 月至 2016 年 1 月期间,338 例患者使用 SAPIEN XT 球囊扩张瓣膜进行 TAVI,而在 CURRENT AS 注册中心,2003 年 1 月至 2011 年 12 月期间,237 例严重 AS 患者接受 SAVR。进行倾向评分匹配后,最终纳入 306 例患者。两组全因死亡和心力衰竭(HF)住院的 2 年累积发生率无显著差异(13.7%比 12.4%[P=0.81]和 7.9%比 3.9%[P=0.13])。调整残余混杂因素后,TAVI 组与 SAVR 组之间全因死亡(风险比[HR]0.74;95%置信区间[CI]0.35-1.58;P=0.43)或 HF 住院(HR 1.27;95%CI 0.40-4.59;P=0.69)的风险无显著差异。
来自这 2 个日本独立注册中心的研究结果表明,在日本的真实世界实践中,TAVI 与 SAVR 组的 2 年全因死亡率和 HF 风险无显著差异。