Harvard Clinical Research Institute, Boston VA Healthcare System, Boston, Massachusetts, USA.
J Am Coll Cardiol. 2012 Aug 7;60(6):548-58. doi: 10.1016/j.jacc.2012.03.075. Epub 2012 Jul 18.
This study sought to compare health status and quality-of-life outcomes for patients with severe aortic stenosis (AS) and high surgical risk treated with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR).
For high-risk patients with severe AS, TAVR has been shown to result in similar 12-month survival but differing adverse events compared with AVR.
We evaluated the health status of 628 patients with severe, symptomatic AS at high risk of surgical complications who were randomized to either TAVR or AVR in the PARTNER Trial. Health status was assessed at baseline and 1, 6, and 12 months using the Kansas City Cardiomyopathy Questionnaire, the Short Form-12, and the EuroQol-5D.
The primary outcome, the Kansas City Cardiomyopathy Questionnaire summary score, improved more rapidly with TAVR, but was similar for the 2 groups at 6 and 12 months. However, there was a significant interaction between the benefit of TAVR and access site (transapical vs. transfemoral). Patients eligible for transfemoral TAVR demonstrated significant health status benefits with TAVR versus AVR at 1 month (difference, 9.9 points; 95% confidence interval: 4.9 to 14.9; p < 0.001), whereas patients treated via the TA approach demonstrated no benefits with TAVR compared with AVR at any time point. Results for Kansas City Cardiomyopathy Questionnaire subscales and generic measures demonstrated similar patterns.
In high-risk patients with severe AS, health status improved substantially between baseline and 1 year after either TAVR or AVR. TAVR via the transfemoral, but not the transapical route, was associated with a short-term advantage compared with surgery. (Placement of AoRTic TraNscathetER Valve [PARTNER] trial; NCT00530894).
本研究旨在比较经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术（AVR）治疗高危重度主动脉瓣狭窄（AS）患者的健康状况和生活质量结局。
对于高危重度 AS 患者，TAVR 与 AVR 相比，12 个月生存率相似，但不良事件不同。
我们评估了 PARTNER 试验中 628 例高危、有症状的重度 AS 患者的健康状况，这些患者随机接受 TAVR 或 AVR 治疗。使用堪萨斯城心肌病问卷、SF-12 量表和 EQ-5D 在基线、1、6 和 12 个月评估健康状况。
主要结局，堪萨斯城心肌病问卷综合评分，TAVR 改善更快，但两组在 6 和 12 个月时相似。然而，TAVR 的获益与入路（经心尖 vs. 经股）之间存在显著的交互作用。适合经股 TAVR 的患者，TAVR 与 AVR 相比，在 1 个月时具有显著的健康状况获益（差值为 9.9 分；95%置信区间：4.9 至 14.9；p<0.001），而经 TA 入路治疗的患者在任何时间点均未从 TAVR 中获益。堪萨斯城心肌病问卷亚量表和通用测量的结果显示出相似的模式。
在高危重度 AS 患者中，TAVR 或 AVR 治疗后，健康状况在基线和 1 年内均有显著改善。经股 TAVR（而非经心尖 TAVR）与手术相比，具有短期优势。（Placement of AoRTic TraNscathetER Valve [PARTNER] trial；NCT00530894）。
