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Women with severe aortic stenosis (AS)
face a higher risk of mortality than men
of the same age.1
Medtronic has invested in the first-ever randomized, head-to-head trial comparing Evolut™ TAVI and SAPIEN™* TAVI systems in patients with small aortic annuli. This patient population is predominantly women, who are often underrepresented and understudied in clinical trials.2
Adapted from: Ana C. Iribarren et al. (2022)11 and Snir, A. D. et al. (2021)12
Significantly less BVD†
with Evolut™ TAVI
vs. SAPIEN™* TAVI in small annulus patients.‡,1
p < 0.001
Calculated from 1 as inverse adj. OR of 1.49 for men to receive AVR, from 7 as OR of 0.65 for women to receive AVR, from 8 as HR of 0.68 for women to receive AVR, from 9 as HR of 0.88 for women to undergo AVR and from 10 as HR of 0.8 for women to receive AVR
Valve performance as defined as freedom from bioprosthetic valve dysfunction (BVD) through 24 months. BVD is defined as a composite including any of the following: hemodynamic structural valve dysfunction (mean gradient ≥ 20 mmHg), non-structural valve dysfunction (severe prothesis-patient mismatch or ≥ moderate aortic regurgitation), clinical thrombosis, endocarditis, and aortic valve reintervention.
In patients with small annuli (area ≤ 430 mm2 ) in all-comers trial, consisting of majority low surgical risk participants (52.1%)
1. Tribouilloy C, et al. Excess Mortality and Undertreatment of Women With Severe Aortic Stenosis. J Am Heart Assoc. 2021 Jan 5;10(1):e018816. doi: 10.1161/JAHA.120.018816. Epub 2020 Dec 29. PMID: 33372529; PMCID: PMC7955469.
2. Herrmann H, et al. SMART 2 Year Data Update. Presented at CRT; March 2025.
3. Chaker Z, Badhwar V, Alqahtani F, Aljohani S, Zack CJ, Holmes DR, Rihal CS, Alkhouli M. Sex differences in the utilization and outcomes of surgical aortic valve replacement for severe aortic stenosis. J Am Heart Assoc 2017;6.
4. Cote N, Clavel MA. Sex differences in the pathophysiology, diagnosis, and management of aortic stenosis. Cardiol Clin 2020;38:129138.
5. Vahanian, A. et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur. Hear. J. 43, ehab395- (2021).
6. Bach D et al., Prevalence, referral patterns, testing, and surgery in aortic valve disease: leaving women and elderly patients behind? J. Heart Valve Dis 16 (2007) 362–369.
7. Rice CT, Barnett S, O’Connell SP, et al. Impact of gender, ethnicity and social deprivation on access to surgical or transcatheter aortic valve replacement in aortic stenosis: a retrospective database study in England. Open Heart 2023;10:e002373. doi:10.1136/ openhrt-2023-002373
8. Paquin, A., Annabi, M. S., Bienjonetti-Boudreau, D., Pibarot, P. & Clavel, M. A. Increased mortality and intervention delay in female patients with severe aortic stenosis and reduced ejection fraction undergoing aortic valve replacement. Can. J. Cardiol. 37, e2 (2021).
9. David Bienjonetti-Boudreau, Marie-Ange Fleury, Martine Voisine, Amélie Paquin, Isabelle Chouinard, Mathieu Tailleur, Raphael Duval, Pierre-Olivier Magnan, Jonathan Beaudoin, Erwan Salaun, Marie-Annick Clavel, Impact of sex on the management and outcome of aortic stenosis patients, European Heart Journal, Volume 42, Issue 27, 14 July 2021, Pages 2683–2691, https://doi.org/10.1093/eurheartj/ehab243
10. Lowenstern A, et al. Sex disparities in patients with symptomatic severe aortic stenosis. Am Heart J. 2021 Jul;237:116-126. doi: 10.1016/j.ahj.2021.01.021. Epub 2021 Mar 17. PMID: 33722584
11. Ana C. Iribarren, et al., Sex differences in aortic stenosis: Identification of knowledge gaps for sex-specific personalized medicine, American Heart Journal Plus: Cardiology Research and Practice, Volume 21,2022,100197,ISSN 2666-6022, https://doi.org/10.1016/j.ahjo.2022.100197
12. Snir, A. D. et al. Prevalence and Outcomes of Low‐Gradient Severe Aortic Stenosis—From the National Echo Database of Australia. J. Am. Hear. Assoc. 10, e021126 (2021).
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