Five-Year Health Status After Self-expanding Transcatheter or Surgical Aortic Valve Replacement in High-risk Patients With Severe Aortic Stenosis.

IMPORTANCE

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.

OBJECTIVE

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.

MAIN OUTCOMES AND MEASURES

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).

RESULTS

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.

CONCLUSIONS AND RELEVANCE

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.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01240902.