10-Year Randomized Outcomes of Transcatheter or Surgical Aortic Valve Replacement in Intermediate-Risk Aortic Stenosis.

Our goal was to compare 10-year clinical and echocardiographic outcomes after balloon-expandable TAVR or surgery in intermediate-risk surgical patients in the PARTNER 2A randomized trial.

我们的目标是在PARTNER 2A随机试验中，比较中等风险外科手术患者在球囊扩张TAVR或手术后10年的临床和超声心动图结果。

Methods

Between 2011 and 2013, patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized at 57 centers to TAVR with the balloon-expandable SAPIEN XT system (Edwards Lifesciences) or to surgery.

在2011年至2013年间，中等手术风险的严重、有症状主动脉瓣狭窄患者在57个中心被随机分配接受球囊扩张式SAPIEN XT系统（爱德华兹生命科学公司）的经导管主动脉瓣置换术（TAVR）或接受外科手术。

Randomization was stratified by anatomical suitability for transfemoral (TF) or transthoracic (transapical/transaortic [TA/TAo]) access.

随机分组是根据患者解剖结构适合经股动脉（TF）或经胸（经心尖/经主动脉[TA/TAo]）途径进行分层。

Ten-year outcomes were evaluated in the valve implant population and included all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes.

在瓣膜植入人群中评估了10年的结果，包括全因死亡率、主动脉瓣再干预和核心实验室审核的超声心动图结果。

To obtain 10-year data, patient reconsent at 5 years was required, and vital status sweeps were implemented to improve data completeness for all-cause mortality.

为了获得10年的数据，需要在5年时重新获得患者的同意，并实施生命状态调查以提高全因死亡率数据的完整性。

Results

Among 1,910 randomized patients who received a valve, 974 underwent TAVR (TF: 749/974 [76.9%]) and 936 had surgery.

在1,910名接受瓣膜植入的随机患者中，974人接受了经导管主动脉瓣置换术（TF: 749/974 [76.9%]），936人接受了手术。

Mean patient age was 81.6 years, 45.4% were women, and the mean Society of Thoracic Surgeons score was 5.8%.

患者的平均年龄为81.6岁，45.4%为女性，平均的胸外科医师学会评分为5.8%。

At 10 years, vital status was available for 881 of 974 patients (90.5%) and 838 of 936 patients (89.5%).

在10年时，974名患者中有881名（90.5%）和936名患者中有838名（89.5%）的生存状态是已知的。

All-cause 10-year mortality with vital status sweeps was 86.1% after TAVR and 82.8% after surgery (HR: 1.13; 95% CI: 1.02-1.25; P = 0.02).

在有生存状态记录的情况下，TAVR术后10年全因死亡率为86.1%，手术后为82.8%（HR: 1.13; 95% 置信区间: 1.02-1.25; P = 0.02）。

When stratified by access route, rates of all-cause mortality for TAVR and surgery in the TF group were similar (83.9% vs 82.1%, respectively; P = 0.27), whereas mortality was higher for TAVR in the TA/TAo group (93.2% vs 85.1%; P < 0.01; P for interaction = 0.03).

当按入路方式分层时，经股动脉（TF）组中TAVR和手术的全因死亡率相似（分别为83.9%和82.1%；P = 0.27），而在经锁骨下动脉（TA）/经升主动脉（TAo）组中，TAVR的死亡率更高（93.2%对85.1%；P < 0.01；交互作用P = 0.03）。

Cumulative incidencerates of aortic valve reintervention at 10 years were 6.3% for TAVR and 1.6% for surgery (P < 0.001).

10年时，主动脉瓣膜再次干预的累积发生率为TAVR组6.3%，手术组1.6%（P < 0.001）。

Of the 24 TAVR and 35 surgical patients with available echocardiographic data at 10 years, mean gradients were 12.6 mm Hg and 12.7 mm Hg, respectively.

在有10年随访的24例经导管主动脉瓣置换术(TAVR)和35例外科手术患者中，平均压力梯度分别为12.6毫米汞柱和12.7毫米汞柱。

Conclusions

At the 10-year follow-up, TAVR in intermediate-risk patients with the SAPIEN XT prosthesis compared with surgery was associated with lower survival rates, with differences predominantly observed in the TA/TAo access cohort.

在10年的随访中，与外科手术相比，使用SAPIEN XT瓣膜的中危患者经导管主动脉瓣置换术(TAVR)的生存率较低，差异主要在TA/TAo入路队列中观察到。

TAVR with the XT valve was also associated with significantly higher rates of aortic valve reintervention.

使用XT瓣膜的经导管主动脉瓣置换术（TAVR）也与显著更高的主动脉瓣再次干预率相关。

(PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk [PII A]; NCT01314313).

（PARTNER II试验：放置主动脉跨腔体瓣膜II - XT中高风险 [PII A]; NCT01314313）。