Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
University of Missouri-Kansas City, Kansas City.
JAMA Cardiol. 2021 Jan 1;6(1):97-101. doi: 10.1001/jamacardio.2020.4397.
In the CoreValve High-Risk Trial, patients with severe symptomatic aortic stenosis had similar clinical outcomes with transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) over 5 years of follow-up, with mortality rates of more than 50% in both groups.
To describe the long-term health status of surviving patients randomized to self-expanding TAVR vs SAVR.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included patients at high surgical risk with severe aortic stenosis who completed a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and were randomized to either self-expanding TAVR or SAVR from 45 US clinical sites. Patients were enrolled from February 2011 to September 2012. Analysis began May 2018 and ended June 2020.
Change in KCCQ and the 12-Item Short-Form Health Survey over 5 years, as assessed by repeated-measures analysis of covariance. Because there were significant interactions between access site and treatment for 1-month health status outcomes, all analyses were stratified by access site (iliofemoral or noniliofemoral).
Of 713 patients, 377 (53%) were men, and the mean (SD) age was 83 (7) years. Prior to treatment, the mean (SD) KCCQ overall summary score (range, 0-100; higher score indicated better health status) was 47 (23), indicating substantial health status impairment. Among surviving patients, the KCCQ overall summary score increased significantly in both groups with greater early benefit with iliofemoral TAVR than SAVR (1-month difference, 16.8 points; 95% CI, 12.4-21.2). However, this early treatment difference between TAVR and SAVR was no longer apparent by 6 months, and there was no significant difference in health status between groups thereafter. At 5 years, 44% (134 of 305) of patients who underwent iliofemoral TAVR and 39% (105 of 266) who underwent SAVR were alive in this high-risk elderly cohort. Among surviving patients for whom health status data were available, 61% (48 of 79) in the TAVR group and 65% (46 of 71) in the SAVR group had KCCQ overall summary score more than 60 (P = .61). In the noniliofemoral cohort, there were no significant health status differences at any time between TAVR and SAVR. Results were similar for individual KCCQ domains and the Short-Form Health Survey.
In high-risk patients with severe symptomatic aortic stenosis, there was an early health status benefit with self-expanding iliofemoral TAVR vs SAVR but no difference between groups in long-term health status. Although mortality at 5 years was high in this population, the majority of surviving patients continued to report reasonable health status.
ClinicalTrials.gov Identifier: NCT01240902.
在 CoreValve 高危试验中，严重症状性主动脉狭窄患者接受经导管主动脉瓣置换术（TAVR）与外科主动脉瓣置换术（SAVR）治疗，5 年随访期间的临床结局相似，两组死亡率均超过 50%。
描述随机分配至自膨式 TAVR 与 SAVR 的存活患者的长期健康状况。
设计、地点和参与者：这是一项随机临床试验，纳入了来自美国 45 个临床站点的高危手术严重主动脉狭窄患者，他们在基线时完成了堪萨斯城心肌病问卷（KCCQ），并随机分配至自膨式 TAVR 或 SAVR 组。患者于 2011 年 2 月至 2012 年 9 月期间入组。分析于 2018 年 5 月开始，2020 年 6 月结束。
使用重复测量协方差分析评估 5 年内 KCCQ 和 12 项简短健康调查的变化。由于 1 个月健康状况结局的入路和治疗之间存在显著交互作用，所有分析均按入路（股髂或非股髂）分层。
在 713 例患者中，377 例（53%）为男性，平均（SD）年龄为 83（7）岁。治疗前，KCCQ 总体综合评分（范围，0-100；评分越高表示健康状况越好）的平均（SD）为 47（23），表明健康状况严重受损。在存活患者中，两组的 KCCQ 总体综合评分均显著增加，股髂 TAVR 早期获益大于 SAVR（1 个月差异，16.8 分；95%CI，12.4-21.2）。然而，TAVR 和 SAVR 之间的这种早期治疗差异在 6 个月时不再明显，此后两组之间的健康状况没有显著差异。5 年时，44%（134/305）接受股髂 TAVR 的患者和 39%（105/266）接受 SAVR 的患者在这一高危老年队列中存活。在有健康状况数据的存活患者中，61%（48/79）的 TAVR 组和 65%（46/71）的 SAVR 组的 KCCQ 总体综合评分超过 60（P=0.61）。在非股髂组中，TAVR 和 SAVR 之间在任何时间点均无显著健康状况差异。单个 KCCQ 域和简短健康调查的结果相似。
在高危严重症状性主动脉狭窄患者中，与 SAVR 相比，经股髂自膨式 TAVR 早期有健康状况获益，但两组的长期健康状况无差异。尽管该人群的 5 年死亡率较高，但大多数存活患者仍继续报告合理的健康状况。
ClinicalTrials.gov 标识符：NCT01240902。
