TAVI superior to surgery in women with aortic stenosis

In women with severe symptomatic aortic stenosis (AS), transcatheter aortic valve implantation (TAVI) is superior to conventional surgery in terms of reducing death, stroke, and rehospitalization at 1 year, according to the RHEIA* trial presented at ESC 2024.

At 1-year follow-up, the incidence of the primary composite endpoint of all-cause mortality, stroke, and rehospitalization was significantly lower in the TAVI arm than in the surgery arm (8.9 percent vs 15.6 percent; hazard ratio [HR], 0.55). This resulted in an absolute event rate difference of -6.8 percent (p<0.001 for noninferiority and p=0.034 for superiority). [ESC 2024, Hot Line Session 5]

“The RHEIA trial demonstrated not only the noninferiority of TAVI but [also] its superiority over surgery for improving outcomes,” said principal investigator Professor Hélène Eltchaninoff from the University Hospital of Rouen, France.

This investigator-initiated, prospective RHEIA trial recruited 443 women (mean age 73 years) all-comers with severe symptomatic AS from 48 sites across 12 countries. The participants were randomized in a 1:1 ratio to undergo TAVI using the SAPIEN 3/SAPIEN 3 Ultra valve (n=221) or surgery with any commercially available surgical valve (n=222). The study’s primary composite endpoint was all-cause mortality, stroke, and rehospitalization for valve- or procedure-related symptoms or worsening heart failure at 1 year.

Upon assessing the individual components of the primary composite endpoint, it was determined that the significant reduction in the primary endpoint observed with TAVI was primarily due to the reduction in rehospitalization for valve- or procedure-related symptoms or worsening heart failure (4.8 percent vs 11.4 percent; difference, -6.6 percent; p=0.02) compared with surgery.

The rates of all-cause mortality (0.9 percent vs 2 percent) and stroke (3.3 percent vs 3 percent) did not significantly differ between the two groups.

Regarding key secondary endpoints, the incidence of new-onset atrial fibrillation was significantly lower with TAVI than with surgery at 1 year (3.3 percent vs 28.8 percent; difference, -25.5 percent; p<0.001). However, a higher rate of new permanent pacemaker implantation was observed after TAVI (8.8 percent vs 2.9 percent; difference, 5.9 percent; p=0.01).

TAVI patients were more likely to be discharged home (90.2 percent vs 49.8 percent) with a shorter median hospital stay of 4 vs 9 days. “[This] added benefit of shorter index hospitalizations meant that TAVI treatment was able to reduce healthcare resource utilization,” Eltchaninoff noted.

Additionally, those who underwent TAVI recovered faster, as shown by improvement in KCCQ**-overall summary score at 1 year (difference, 20.64 vs 18.43 points), than those who had surgery.

“Limited data suggest that transcatheter, as compared with surgical, aortic valve replacement may be more effective in female than male patients,” said Eltchaninoff. “[Now,] in this first dedicated randomized TAVI trial in women, we were able to confirm its superiority over surgery, particularly with respect to reducing rehospitalizations,” said Eltchaninoff.

“Although we acknowledge the short postintervention interval and longer follow-up will be useful, our findings suggest that in women with severe symptomatic AS, TAVI using balloon-expandable devices could be considered the preferred therapy,” Eltchaninoff noted.