Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Cardiovasc Interv Ther. 2021 Jan;36(1):121-130. doi: 10.1007/s12928-020-00658-2. Epub 2020 Mar 13.
Two randomized control trials demonstrated that transcatheter aortic valve implantation was associated with 1-2 year clinical outcomes comparable or even superior to surgical aortic valve replacement (SAVR) in low surgical risk patients with severe aortic stenosis (AS). However, no previous study has reported the clinical outcomes after SAVR in Japanese patients with low surgical risk. From 3815 consecutive patients enrolled in the CURRENT AS registry, we retrieved 220 patients who underwent SAVR in reference to the inclusion and exclusion criteria of the PARTNER 3 trial. Age and surgical risk score in the current study population were comparable to those in the PARTNER 3 trial (Age: 75 years versus 74 years, and STS-PROM score: 2.3 versus 1.9). The cumulative incidence of a composite all-cause death or stroke was comparable between the current study population and the SAVR patients in the PARTNER 3 trial both at 30-day (2.3% versus 3.3%), and at 1-year (4.1% versus 4.9%). The clinical outcomes of SAVR in low surgical risk patients with severe AS selected from a real world Japanese registry according to the inclusion and exclusion criteria of the PARTNER 3 trial was favorable and numerically comparable to those of SAVR patients in the PARTNER 3 trial.
两项随机对照试验表明,在低手术风险的重度主动脉瓣狭窄(AS)患者中,经导管主动脉瓣植入术(TAVI)与外科主动脉瓣置换术(SAVR)相比,1-2 年的临床结局相当甚至更优。然而,以前没有研究报告过日本低手术风险患者接受 SAVR 后的临床结果。我们从 CURRENT AS 注册中心的 3815 例连续患者中,根据 PARTNER 3 试验的纳入和排除标准,检索到 220 例接受 SAVR 的患者。当前研究人群的年龄和手术风险评分与 PARTNER 3 试验相当(年龄:75 岁对 74 岁,STS-PROM 评分:2.3 对 1.9)。当前研究人群和 PARTNER 3 试验中 SAVR 患者的复合全因死亡或卒中的累积发生率在 30 天(2.3%对 3.3%)和 1 年(4.1%对 4.9%)时均相当。根据 PARTNER 3 试验的纳入和排除标准,从真实世界的日本注册中心中选择的低手术风险严重 AS 患者的 SAVR 临床结果良好,且在数值上与 PARTNER 3 试验中的 SAVR 患者相当。