The RHEIA trial, a dedicated study focusing on women with severe aortic stenosis, has revealed that transcatheter aortic valve implantation (TAVI) is more effective than surgical aortic valve replacement in reducing the risk of death, stroke, or rehospitalization. The late-breaking research, presented at ESC Congress 2024, marks a significant step forward in tailoring treatment strategies for this patient population.
Superior Outcomes with TAVI
The prospective, randomized RHEIA trial enrolled 443 women with severe symptomatic aortic stenosis across 48 sites in 12 European countries. Participants were randomized to undergo either TAVI with a third-generation balloon-expandable system via transfemoral access or surgical aortic valve replacement. The primary composite endpoint assessed all-cause mortality, stroke, and rehospitalization for valve- or procedure-related symptoms or worsening heart failure at one year.
The results indicated a significantly lower incidence of the primary composite endpoint in the TAVI group (8.9%) compared to the surgical group (15.6%), with a hazard ratio of 0.55 (95% CI: 0.34-0.88; p=0.03). This advantage was largely driven by a reduction in rehospitalizations, which occurred in 4.8% of TAVI patients versus 11.4% of surgical patients (p=0.02).
Additional Benefits and Considerations
Beyond the primary endpoint, TAVI demonstrated a lower incidence of new-onset atrial fibrillation at one year (3.3% vs. 28.8%; p<0.001) and a shorter median length of hospital stay (4 days vs. 9 days). However, TAVI was associated with higher rates of new permanent pacemaker implantation (8.8% vs. 2.9%; p=0.01) and mild paravalvular aortic regurgitation at one year (15.5% vs. 2.4%; p<0.001).
Professor Helene Eltchaninoff of the University Hospital of Rouen, France, a principal investigator of the trial, noted, "In this first dedicated randomised TAVI trial in women, we were able to confirm its superiority over surgery, particularly with respect to reducing rehospitalisations... our findings suggest that in women with severe symptomatic aortic stenosis, TAVI using balloon-expandable devices could be considered the preferred therapy."
Industry Reaction
Larry Wood, an Edwards corporate vice president and the company’s group president of TAVR and surgical structural heart, stated, “We are proud of this high-quality clinical research to inform patients’ decisions about the treatment of their heart valve failure.”
Medtronic also commented on the RHEIA results, emphasizing that studies have consistently linked TAVI with encouraging outcomes for women and other patients with small aortic annuli. The company said, “At Medtronic, we recognize the importance of clinical studies in helping to foster revolutionary change that advances medicine and patient care…We are committed to developing life-transforming technology that is grounded in sound evidence and appreciate the RHEIA Trial investigators for their work in advancing women’s cardiovascular health.”
Implications for Clinical Practice
The RHEIA trial provides compelling evidence supporting the use of TAVI as a preferred treatment option for women with severe symptomatic aortic stenosis. The reduction in rehospitalizations and shorter hospital stays associated with TAVI could lead to reduced healthcare resource utilization and improved patient outcomes. While longer-term follow-up data will be valuable, the current findings suggest a paradigm shift in the management of aortic stenosis in women.
