Treating severe aortic stenosis: TAVI superior to SAVR in female patients
Transcatheter aortic valve implantation (TAVI) has been observed as being superior to surgical aortic valve replacement (SAVR) for reducing mortality rate, stroke occurrence and rehospitalization in a large female patient cohort with severe aortic stenosis.
Results from the Randomized Research in Women All-Comers with Aortic Stenosis (RHEIA) trial were recently presented at the European Society of Cardiology Congress 2024 (30 August–2 September, London, UK). The findings indicate that TAVI is a better option for female patients than SAVR in terms of all-cause mortality, stroke incidence and rehospitalization.
Currently, the prognosis for patients with severe aortic stenosis is typically 1–2 years once symptoms begin. Earlier subgroup analyses from larger trials have hinted that TAVI may be more effective in female than male patients, however, these insights remained unconfirmed till the dedicated RHEIA trial
The recent RHEIA trial involved 443 female patients from 12 different European countries. All patients involved were classified as having severe symptomatic aortic stenosis, where patients with high surgical risk were excluded. Patients were randomly assigned to partake in either TAVI or SAVR and were all followed up with after 1 year.
At follow-up, a composite primary endpoint of all-cause mortality, stroke incidence and rehospitalization for valve- or procedure-related symptoms or worsening heart failure were measured. This composite measure was observed as being significantly lower in the TAVI group of the trial compared to the SAVR group.
TAVR vs SAVR for patients with aortic stenosis: long-term outcomes
Researchers compared TAVR to outcomes in patients who underwent SAVR, the gold standard for treating severe aortic stenosis.
The significant reduction in the primary endpoint of the TAVI group was mainly driven by a reduction in rehospitalisation for valve- or procedure-related symptoms or worsening heart failure. TAVI was also associated with a lower incident rate of new-onset atrial fibrillation than SAVR at 1 year and a shorter median length of index hospital stays. However, patients in the TAVI group had higher rates of new permanent pacemaker implantation and mild paravalvular aortic regurgitation at 1 year.
Helene Eltchaninoff, one of the principal investigators (Rouen University Hospital, France) remarked, “Limited data suggest that transcatheter, as compared with SAVR may be more effective in female than male patients. As most evidence is derived from subgroup analyses of large trials, we conducted a dedicated randomized trial to compare the safety and efficacy of TAVI vs. surgical replacement in women all-comers with severe symptomatic aortic stenosis. The RHEIA trial demonstrated not only the non-inferiority of TAVI but its superiority over surgery for improving outcomes, particularly reducing rehospitalizations.”
“In this first dedicated randomized TAVI trial in women, we were able to confirm its superiority over surgery, particularly with respect to reducing rehospitalizations. The added benefit of shorter index hospitalisations meant that TAVI treatment was able to reduce healthcare resource utilisation. Although we acknowledge the short post-intervention interval and longer follow-up will be useful, our findings suggest that in women with severe symptomatic aortic stenosis, TAVI using balloon-expandable devices could be considered the preferred therapy,” concluded Eltchaninoff.
