BACKGROUND There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).

中文翻译：

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经导管或外科主动脉瓣置换术的五年结果。

背景 对于重度主动脉瓣狭窄和中等手术风险的患者，与手术主动脉瓣置换术相比，经导管主动脉瓣置换术 (TAVR) 后的长期临床结果和生物瓣膜功能的数据很少。方法 我们在 57 个中心招募了 2032 名患有严重、有症状主动脉瓣狭窄的中危患者。根据打算经股动脉或经胸腔入路（分别为 76.3% 和 23.7%）对患者进行分层，并随机分配接受 TAVR 或手术置换。临床、超声心动图和健康状况结果被随访 5 年。主要终点是全因死亡或致残性中风。结果 5 年时，TAVR 组和手术组之间全因死亡或致残性中风的发生率没有显着差异（分别为 47.9% 和 43.4%；风险比为 1.09；95% 置信区间 [CI] ，0.95 至 1.25；P = 0.21）。经股动脉入路队列的结果相似（分别为 44.5% 和 42.0%；风险比为 1.02；95% CI，0.87 至 1.20），但 TAVR 后死亡或致残性卒中的发生率高于经胸腔手术后- 访问队列（59.3% vs. 48.3%；风险比，1.32；95% CI，1.02 至 1.71）。5 年时，TAVR 组中至少有轻度瓣周主动脉瓣关闭不全的患者多于手术组（33.3% vs. 6.3%）。TAVR 后重复住院的频率比手术后更高（33.3% 比 25.2%），主动脉瓣再干预也是如此（3.2% 比 0.8%）。TAVR 和手术 5 年时健康状况的改善相似。结论 在处于中等手术风险的主动脉瓣狭窄患者中，与主动脉瓣置换术相比，TAVR 术后 5 年死亡或致残性中风的发生率没有显着差异。（由 Edwards Lifesciences 资助；PARTNER 2 ClinicalTrials.gov 编号，NCT01314313。）。