Health Status Outcomes 7 Years After Transcatheter or Surgical Aortic Valve Replacement in Low-Surgical Risk Patients With Aortic Stenosis.

However, long-term data comparing the detailed health status outcomes of these 2 treatments are lacking.

然而，缺乏比较这两种治疗方法详细健康状况结果的长期数据。

The purpose of this study was to compare long-term health status outcomes between TAVR and SAVR in low-risk patients and explore heterogeneity of treatment effect.

本研究的目的是比较低风险患者中TAVR和SAVR的长期健康状况结果，并探讨治疗效果的异质性。

Methods

The PARTNER 3 (Placement of Aortic Transcatheter Valves) trial randomized patients with severe aortic stenosis and low surgical risk 1:1 to TAVR with a balloon-expandable valve vs SAVR.

PARTNER 3（经导管主动脉瓣膜植入）试验将低手术风险的重度主动脉瓣狭窄患者1:1随机分为经导管主动脉瓣置换术（使用球囊扩张瓣膜）与外科主动脉瓣置换术。

Health status was evaluated with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Short Form-36 Heath Survey at baseline and 1 month, 6 months, and annually from years 1 to 7.

健康状况通过堪萨斯城心肌病问卷（KCCQ）和36项健康调查（SF-36）在基线以及1个月、6个月以及从第1年到第7年的每年进行评估。

Between treatment group differences in health status scores over time were examined with mixed effects models for repeated measures adjusted for baseline.

使用混合效应模型重复测量方法，调整基线后，检查了随时间变化的治疗组间健康状况评分的差异。

Results

The analytic cohort included 943 patients enrolled in the PARTNER 3 trial who had baseline KCCQ assessments and underwent their assigned procedure (494 TAVR, 449 SAVR; mean age: 73.5 ± 5.9 years; 69.2% men; mean Society of Thoracic Surgeons-Predicted Risk of Mortality: 1.9% ± 0.6%; mean KCCQ-overall summary [KCCQ-OS] score: 70.9 ± 20.5).

分析队列包括943名参与PARTNER 3试验的患者，这些患者有基线KCCQ评估并接受了他们被分配的程序（494名TAVR，449名SAVR；平均年龄：73.5 ± 5.9岁；69.2%为男性；平均胸外科医师学会预测死亡风险：1.9% ± 0.6%；平均KCCQ总体摘要[KCCQ-OS]评分：70.9 ± 20.5）。

TAVR and SAVR both resulted in significant improvements in KCCQ and Short Form-36 Heath Survey summary scores relative to baseline through 7-year follow-up.

TAVR和SAVR都导致了与基线相比，KCCQ和36项健康调查摘要评分在7年随访期间有显著改善。

KCCQ-OS scores were substantially higher at 1 month after TAVR vs SAVR (mean treatment difference: +16.2 points; 95% CI: 14.3-18.1) and remained modestly higher through 2 years of follow-up (mean difference at 2 years: +1.9 points; 95% CI: 0.2-3.7), but there were no significant between-group differences in years 3-7.

TAVR术后1个月的KCCQ-OS评分显著高于SAVR（平均治疗差异：+16.2分；95%置信区间：14.3-18.1），并且在长达2年的随访期间保持适度的高分（2年时的平均差异：+1.9分；95%置信区间：0.2-3.7），但在第3-7年期间两组之间没有显著差异。

At 7 years, ∼60% of patients in both treatment groups had an excellent outcome (alive, KCCQ-OS ≥75; no KCCQ-OS decline ≥10 from baseline).

在7年时，两个治疗组中约60%的患者有极好的结果（存活，KCCQ-OS ≥75；与基线相比无KCCQ-OS下降≥10）。

Conclusions

Patients with severe aortic stenosis at low surgical risk had substantial improvement in patient-reported health status with either TAVR or SAVR that was sustained through 7 years.

低手术风险的严重主动脉瓣狭窄患者在接受TAVR或SAVR治疗后，患者报告的健康状况有显著改善，并且这种改善持续到7年。

Patients had earlier recovery with TAVR, but health status outcomes after 2 years were similar between treatment groups.

TAVR患者的恢复更早，但在2年后的健康状况结果在两个治疗组之间相似。

(PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis; NCT02675114).

PARTNER 3试验：在低风险主动脉瓣狭窄患者中使用SAPIEN 3经导管心脏瓣膜的安全性和有效性；NCT02675114。