10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients.

However, long-term outcomes data are lacking for TAVR, particularly with newer-generation transcatheter heart valves.

然而，关于TAVR的长期结果数据特别是对于新一代经导管心脏瓣膜的长期结果数据仍然缺乏。

The purpose of this study was to compare 10-year outcomes of intermediate-risk patients who underwent TAVR with the third-generation, balloon-expandable SAPIEN 3 valve in the PARTNER 2 SAPIEN 3 Intermediate-risk Registry (P2S3i) with those who underwent surgery in the PARTNER 2A (P2A) randomized trial.

本研究旨在比较使用第三代球囊扩张型SAPIEN 3瓣膜在PARTNER 2 SAPIEN 3中危风险注册研究（P2S3i）中接受经导管主动脉瓣置换术（TAVR）的中危风险患者与在PARTNER 2A（P2A）随机试验中接受手术治疗患者的10年预后。

Methods

Intermediate-risk patients were enrolled in the P2A trial from 2011 through 2013 and in the P2S3i registry in 2014.

中危风险患者在2011年至2013年期间被纳入P2A试验，并在2014年被纳入P2S3i注册研究。

These prospective, multicenter studies used the same eligibility criteria and stratified patients based on suitability for transfemoral or transthoracic (transapical/transaortic) access.

这些前瞻性的多中心研究使用了相同的入选标准，并根据患者适合经股动脉或经胸（经心尖/经主动脉）途径进行了分层。

Ten-year outcomes were evaluated, including all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes.

评估了包括全因死亡率、主动脉瓣再次干预以及核心实验室判定的心脏超声结果在内的十年结果。

Patient reconsent was required at 5 years for extended 10-year follow-up, and vital status sweeps were implemented to improve data completeness for all-cause mortality.

在5年时需要患者重新同意以进行延长至10年的随访，并实施生命状态调查以提高全因死亡率数据的完整性。

To account for potential baseline differences and reduce confounding, P2S3i TAVR patients were propensity score-matched 1:1 to P2A surgical patients.

为了考虑潜在的基线差异并减少混杂因素，P2S3i TAVR患者与P2A手术患者进行了1:1的倾向得分匹配。

Results

Among 2,005 patients who received a valve, 1,069 underwent TAVR in P2S3i and 936 underwent surgery in P2A.

在接受瓣膜置换的2,005名患者中，有1,069名在P2S3i接受了经导管主动脉瓣置换术(TAVR)，936名在P2A接受了手术。

After propensity score matching (N = 783 patients in each group), baseline characteristics were similar between groups: mean age was approximately 82 years, 43% were female, and mean Society of Thoracic Surgeons score was 5.5%.

在倾向性评分匹配后（每组783名患者），两组的基线特征相似：平均年龄约为82岁，43%为女性，平均胸外科医师学会评分为5.5%。

At 10 years, all-cause mortality rate was 83.4% after TAVR and 82.3% after surgery, respectively (HR: 1.01 [95% CI: 0.91-1.13]; P = 0.82).

在10年时，经TAVR治疗后的全因死亡率为83.4%，手术治疗后的全因死亡率为82.3%（HR: 1.01 [95% 置信区间: 0.91-1.13]; P = 0.82）。

Aortic valve reintervention rates adjusted for competing mortality were 2.0% for TAVR and 1.9% for surgery (P = 0.47).

调整竞争性死亡率后，TAVR的主动脉瓣再次干预率为2.0%，手术的主动脉瓣再次干预率为1.9%（P = 0.47）。

Among 32 TAVR and 30 surgical patients with available echocardiographic data at 10 years, mean gradients were 11.0 mm Hg and 12.6 mm Hg, respectively.

在有10年随访的32例经导管主动脉瓣置换术（TAVR）和30例外科手术患者中，平均压力梯度分别为11.0毫米汞柱和12.6毫米汞柱。

Conclusions

At 10 years, TAVR with the SAPIEN 3 valve and surgery resulted in similar rates of mortality and aortic valve reintervention, and similar hemodynamics in intermediate-risk patients with symptomatic severe aortic stenosis.

在10年的随访中，使用SAPIEN 3瓣膜的经导管主动脉瓣置换术（TAVR）和外科手术在中危患者中导致的死亡率和主动脉瓣再次干预率相似，且在有症状的严重主动脉瓣狭窄患者中血流动力学相似。

This analysis highlights challenges associated with extended long-term follow-up of clinical trials, including differential loss to follow-up and the competing risk of mortality in elderly populations.

本分析强调了临床试验长期随访所面临的挑战，包括随访丢失的差异性以及老年人群中死亡的竞争风险。

(PARTNER 2A Trial; NCT01314313; PARTNER 2 SAPIEN 3 Intermediate-Risk Registry; NCT03222128).

（PARTNER 2A试验；NCT01314313；PARTNER 2 SAPIEN 3中危人群注册；NCT03222128）。