RHEIA Trial of Women With Severe Aortic Stenosis Compares TAVR Versus Surgery

September 16, 2024—The European Society of Cardiology announced the presentation of the RHEIA trial showing that transcatheter aortic valve implantation/replacement (TAVI/TAVR) was superior to surgical aortic valve replacement for reducing death, stroke, or rehospitalization in women with severe aortic stenosis suggesting that TAVR with the balloon-expandable devices used in the trial could be considered the preferred option to treat women with severe aortic stenosis.

The findings were presented in a Hot Line session at the ESC Congress 2024 held August 30 to September 2 in London, United Kingdom.

According to the ESC press release, the prospective RHEIA trial recruited women all-comers with severe symptomatic aortic stenosis, with any (except prohibitive) surgical risk status, from 48 sites in 12 countries across Europe. In total, 443 patients (mean age, 73 years) were enrolled. The mean Society of Thoracic Surgeons risk score was 2.1%-2.2%. 

The patients were randomized 1:1 to undergo either TAVR with a third-generation balloon-expandable system using transfemoral access or surgical aortic valve replacement and were followed up for 1 year.

The primary composite endpoint was all-cause mortality, stroke, and rehospitalization for valve- or procedure-related symptoms or worsening heart failure at 1 year.

As summarized in the ESC press release, the incidence of the primary composite endpoint was significantly lower in the TAVR group (8.9%) versus the surgical group at 1 year (8.9% vs 15.6%; hazard ratio [HR] 0.55; 95% confidence interval [CI], 0.34 to 0.88; P = .03). The absolute event rate difference between the groups was −6.8% and the upper bound of the two-sided 95% CI met the criteria for both noninferiority and superiority.

The ESC press release noted that the significant reduction in the primary endpoint was predominantly driven by a reduction in rehospitalization for valve- or procedure-related symptoms or worsening heart failure, which occurred in 4.8% in the TAVR group and 11.4% in the surgical group (difference −6.6%; 95% CI, −11.9% to −1.4%; P = .02). There was no significant difference in all-cause mortality or stroke.

Additionally, the investigators found that TAVR was associated with a lower incidence of new-onset atrial fibrillation compared to surgery at 1 year (3.3% vs 28.8%; P < .001) and shorter median length of index hospital stay (4 vs 9 days), but higher rates of new permanent pacemaker implantation (8.8% vs 2.9%; P = .01) and mild paravalvular aortic regurgitation at 1 year (15.5% vs 2.4%; P < .001), stated the ESC.

One of the RHEIA trial principal investigators, Professor Helene Eltchaninoff, MD, of the University Hospital of Rouen in Rouen, France, discussed the findings in the ESC press release.

“Limited data suggest that transcatheter—as compared with surgical—aortic valve replacement may be more effective in female than male patients,” commented Prof. Eltchaninoff in the press release. “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 versus surgical replacement in women all-comers with severe symptomatic aortic stenosis. The RHEIA trial demonstrated not only the noninferiority 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 hospitalizations meant that TAVI treatment was able to reduce healthcare resource utilization.

“Although we acknowledge the short postintervention 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.”