Female sex was associated with a non-significant trend toward lower 4-year all-cause mortality post-TAVI compared to male sex (36.0% vs 39.7%; HR 0.87; 95% CI 0.75-1.02; p=0.0911).
Observational (n=1,694)
Yes
Does sex impact 4-year mortality in high-risk patients undergoing transfemoral TAVI with the SAPIEN 3 valve?
In a real-world cohort of high-risk patients undergoing TAVI with the SAPIEN 3 valve, sex was not an independent predictor of 4-year mortality after adjusting for baseline characteristics.
Hazard Ratio: 0.87 (95% CI 0.75–1.02)
Absolute Event Rate: 36% vs 39.7%
p-value: p=0.0911
OBJECTIVES: To investigate 4-year, post-transcatheter aortic valve implantation (TAVI) survival and predictors of survival by sex, in a real-world cohort that underwent transfemoral TAVI with SAPIEN 3 transcatheter heart valve. BACKGROUND: Previous TAVI investigations of first-generation devices demonstrated an early- to mid-term survival advantage in women compared with men. METHODS: SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) is a post-approval, multicentre, observational registry. Patients (N = 1,694, 49.2% women, age 81.7 ± 6.7 years) with severe aortic stenosis and high surgical risk (logistic EuroSCORE 17.8%) underwent TAVI between 2014 and 2015. Kaplan-Meier event estimates were used to determine mortality by sex. Predictors of overall mortality were identified using a cox multivariate proportional hazard model. RESULTS: At 4 years, women had lower all-cause mortality than men (36.0 vs 39.7%; p = .0911; HR: 0.87 95% CI: 0.75-1.02). No difference was observed for cardiac mortality between women 24.2% and men 24.7% (p = .76; HR: 0.97 95% CI: 0.79-1.19). When adjusted for baseline characteristics (age, height, weight, NYHA functional class, renal insufficiency, EuroScore, and tricuspid regurgitation), sex had no impact on mortality. CONCLUSIONS: In this large, real-world cohort, all-cause mortality trended lower in women than men at 4 years post TAVI; however, several baseline factors, but not sex, were predictors of mortality. No difference between sexes was observed for cardiovascular mortality.
Tarantini et al. (Fri,) conducted a observational in Severe aortic stenosis (n=1,694). Female sex vs. Male sex was evaluated on All-cause mortality (HR 0.87, 95% CI 0.75-1.02, p=0.0911). Female sex was associated with a non-significant trend toward lower 4-year all-cause mortality post-TAVI compared to male sex (36.0% vs 39.7%; HR 0.87; 95% CI 0.75-1.02; p=0.0911).