*TAVI with SAPIEN 3 and SAPIEN 3 Ultra was proven superior to surgery on the composite primary endpoint of death, stroke and rehospitalisation at 1 year in female patients.
Eltchaninoff H et al. RHEIA – Transcatheter versus surgical aortic valve replacement in women with severe aortic stenosis. Presented at ESC Congress, 30 August–2 September 2024, London, UK.
Recent data have demonstrated that, compared with men, women have a lower risk of death after TAVI but a higher risk of death after sAVR.1 In addition, compared with men, women experienced fewer complications with TAVI than sAVR, as seen in the PARTNER 3 Trial at 1 and 5 years.1,2
However, women were under-represented in those trials, and they were not designed to assess the benefits for women specifically.1,2 Data from a dedicated randomised trial evaluating the difference in outcomes in women are needed.
The first woman-only randomised controlled trial in severe symptomatic aortic stenosis (sSAS).3 This investigator-initiated, multicentre, international trial demonstrates the superiority of TAVI with the SAPIEN 3 platform over sAVR in female patients with sSAS for the primary endpoint of all-cause mortality, stroke and rehospitalisation at 1 year.
The primary endpoint demonstrated the superiority of TAVI with the SAPIEN 3 platform over sAVR in female patients’ at 1 year
Secondary endpoint analysis reaffirmed the low pacemaker rate for the Edwards SAPIEN 3/SAPIEN 3 Ultra valve in TAVI patients.
| TAVI, n (%) (N=215) | sAVR, n (%) (N=205) | p-value | |
|---|---|---|---|
| New permanent pacemaker | 19 (8.8) | 6 (2.9) | 0.01 |
| New onset atrial fibrillation | 7 (3.3) | 59 (28.8) | <0.001 |
Excellent haemodynamic performance at 1 year for the SAPIEN 3 platform, with very low rates of paravalvular leak.
Index hospital stay, median:
TAVI: 4.0 days
sAVR: 9.0 days
Valve dysfuction at 1 year (VARC-2)
TAVI: 0.5% (n = 215)
sAVR: 0% (n=205)
Discharged to home or self-care facility:
TAVI: 90.2%
sAVR: 49.8%
Valve reintervention at 1 year
TAVI: 0.9% (n = 215)
sAVR: 0% (n=205)
A rapid and sustained improvement in quality of life was seen after TAVI with the SAPIEN 3 platform, with a significantly larger improvement in KCCQ-OS score, even at 1 year.
+20.7 ± 1.1 points
+18.2 ± 1.2 points
KCCQ-OS: Kansas City Cardiomyopathy Questionnaire - Overall Score
In women with sSAS, TAVI using the Edwards SAPIEN 3 or SAPIEN 3 Ultra valve is superior to sAVR for the primary endpoint of all-cause mortality, stroke or rehospitalisation at 1 year.
These data provide the first specific randomised evidence to inform the choice of treatment in women with sSAS, reinforcing the platform’s consistent lifetime management results.
Click here to see the full results
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References:
1. Mack MJ, Leon MB, Thourani VH et al. Transcatheter aortic valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380: 1695–705.
2. Mack MJ, Leon MB, Thourani VH et al. Transcatheter aortic valve replacement in low-risk patients at five years. N Engl J Med. 2023; 389: 1949–60.
3. Eltchaninoff H, Bonaros N, Prendergast B et al. Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial). Am Heart J. 2020; 228: 27–35.
4. Scotti A, Sturla M, Costa G et al. Evolut PRO and SAPIEN ULTRA performance in small aortic annuli: The OPERA-TAVI Registry. J Am Coll Cardiol Intv. 2024; 17: 681–692.
5. Okuno T, Tomii D, Lanz J et al. 5-year outcomes with self-expanding vs balloon-expandable transcatheter aortic valve replacement in patients with small annuli. JACC Cardiovasc Interv. 2023; 16: 429–440.
6. Hase H, Yoshijima N, Yanagisawa R et al. Transcatheter aortic valve replacement with Evolut R versus SAPIEN 3 in Japanese patients with a small aortic annulus: The OCEAN-TAVI registry. Catheter Cardiovasc Interv. 2021; 97: E875–86.
Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).
PP--EU-8846 v3.0
