TAVI and SAVR showed similar 2-year rates of all-cause mortality or disabling stroke in both females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99) with intermediate-risk aortic stenosis.
RCT (n=1,660)
randomised
Yes
Does TAVI compared to SAVR result in different clinical outcomes or functional status improvements in men versus women with aortic stenosis at intermediate operative risk?
TAVI and SAVR are similarly effective and safe for both men and women at intermediate surgical risk, though functional status appears to improve most in women after TAVI.
p-value: p=0.90 (females), 0.99 (males)
AIMS: In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial. METHODS AND RESULTS: A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p<0.01) and were more frail. Men required more concomitant revascularisation (23% vs 16%). All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99); the difference between females and males was 10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI in females than in males. CONCLUSIONS: Aortic valve replacement, either by surgical or transcatheter approach, appears similarly effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov NCT01586910.
Mieghem et al. (2020) conducted an RCT in aortic stenosis at intermediate operative risk (n=1,660). Transcatheter aortic valve implantation (TAVI) vs. Surgical aortic valve replacement (SAVR) was evaluated on composite of all-cause mortality or disabling stroke at two years (p=0.90 (females), 0.99 (males)). TAVI and SAVR showed similar 2-year rates of all-cause mortality or disabling stroke in both females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99) with intermediate-risk aortic stenosis.