Among high-risk female patients with severe aortic stenosis, TAVR reduced late mortality compared to SAVR (HR 0.67; 95% CI 0.44-1.00; p=0.049), whereas no survival benefit was seen in males.
RCT (n=699)
1:1
Does TAVR improve survival compared to SAVR in high-risk female patients with severe aortic stenosis?
In high-risk patients with severe aortic stenosis, TAVR may offer a survival advantage over SAVR specifically in female patients, particularly via transfemoral access.
Hazard Ratio: 0.67 (95% CI 0.44–1)
p-value: p=0.049
OBJECTIVES: This study sought to examine sex-specific differences in outcomes after surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis. BACKGROUND: The PARTNER (Placement of Aortic Transcatheter Valve) trial demonstrated similar 2-year survival with SAVR or TAVR for high-risk patients, but sex-specific outcomes are unknown. METHODS: In all, 699 patients (300 female) were randomly assigned 1:1 to either SAVR or TAVR with a balloon expandable pericardial tissue valve. Baseline characteristics and 2-year outcomes of TAVR versus SAVR were compared among males and females. RESULTS: Baseline characteristics differed between the sexes. Despite higher Society of Thoracic Surgeons mortality risk scores (11.9 vs. 11.6; p = 0.05), female patients had lower prevalence of coronary artery disease (64.4% vs. 83.7%), prior coronary artery bypass graft surgery (19.8% vs. 61.2%), peripheral vascular disease (36.4% vs. 46.9%), diabetes mellitus (35.6% vs. 45.6%), and elevated creatinine (11.7% vs. 23.9%). Among female patients, procedural mortality trended lower with TAVR versus SAVR (6.8% vs. 13.1%; p = 0.07) and was maintained throughout follow-up (hazard ratio HR: 0.67; 95% confidence interval CI: 0.44 to 1.00; p = 0.049), driven by the transfemoral arm (HR: 0.55; 95% CI: 0.32 to 0.93; p = 0.02). Among male patients, although procedural mortality was lower with TAVR (6% vs. 12.1%; p = 0.03), there was no overall survival benefit (HR: 1.15; 95% CI: 0.82 to 1.61; p = 0.42). CONCLUSIONS: In this retrospective subanalysis of high-risk, symptomatic aortic stenosis patients in the PARTNER trial, female subjects had lower late mortality with TAVR versus SAVR. This was especially true among patients suitable for transfemoral access and suggests that TAVR may be preferred over surgery for high-risk female patients. A randomized, controlled trial conducted specifically in female patients is necessary to properly study differences in mortality between treatment modalities. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).
Williams et al. (2014) conducted an RCT in Severe aortic stenosis (n=699). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on Late mortality (in female patients) (HR 0.67, 95% CI 0.44 to 1.00, p=0.049). Among high-risk female patients with severe aortic stenosis, TAVR reduced late mortality compared to SAVR (HR 0.67; 95% CI 0.44-1.00; p=0.049), whereas no survival benefit was seen in males.