Hot Line: Dedicated trial in women demonstrates TAVI superiority
01 Sep 2024
As explained yesterday by Professor Hélène Eltchaninoff (University Hospital of Rouen – Rouen, France), data from subgroup analyses had suggested that transcatheter aortic valve implantation (TAVI) may be more effective than surgical replacement in female patients. The RHEIA trial compared the relative merits of the two methods in a women-only population.
In total, 443 women all-comers with severe symptomatic aortic stenosis, with any (except prohibitive) surgical risk status, were randomised to either TAVI with a third-generation balloon-expandable system using transfemoral access or surgical aortic valve replacement. The primary composite endpoint was all-cause mortality, stroke and rehospitalisation for valve- or procedure-related symptoms or worsening heart failure at 1 year.
The incidence of the primary endpoint was significantly lower with TAVI (8.9%) vs. surgery (15.6%; hazard ratio 0.55; 95% CI 0.34 to 0.88; p=0.03).
Both the non-inferiority and superiority of TAVI were demonstrated. The significant reduction in the primary endpoint was predominantly driven by a reduction in rehospitalisation for valve- or procedure-related symptoms or worsening heart failure, which occurred in 4.8% in the TAVI group and 11.4% in the surgical group (difference −6.6%; 95% CI −11.9% to −1.4%; p=0.02). There was no significant difference in all-cause mortality or stroke. TAVI was associated with a lower incidence of new-onset atrial fibrillation (3.3% vs. 28.8%; p<0.001) and shorter median length of index hospital stay (4 days vs. 9 days), but higher rates of new permanent pacemaker implantation (8.8% vs. 2.9%; p=0.01) and mild paravalvular aortic regurgitation at 1 year (15.5% vs. 2.4%; p<0.001).
“In this first dedicated randomised TAVI trial in women, we confirmed its superiority over surgery, particularly with respect to reducing rehospitalisations. The added benefit of shorter index hospitalisations meant that TAVI 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 Prof. Eltchaninoff.
