Key Points:
- The RHEIA trial found that TAVI was superior to surgical aortic valve replacement (SAVR) in women with severe aortic stenosis, significantly reducing the composite endpoint of all-cause mortality, stroke, and rehospitalization for valve-related symptoms or worsening heart failure.
- The reduction in the primary endpoint was primarily driven by a significant decrease in rehospitalizations for valve- or procedure-related symptoms in the TAVI group compared to the SAVR group.
- TAVI demonstrated clear advantages over SAVR, suggesting that TAVI could be the preferred therapy for women with severe symptomatic aortic stenosis.
Aortic stenosis (AS) is prevalent in elderly populations, with a growing incidence expected particularly among women due to their longer life expectancy. Recent evidence has pointed towards gender differences in outcomes between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR), with some signal towards increased risk of adverse outcomes after SAVR. In a breaking presentation at the 2024 ESC Congress today, Dr. Eltchaninoff (University Hospital of Rouen, France) and her team presented their study “RHEIA: Transcatheter versus Surgical Aortic Valve Replacement in Women with Severe Aortic Stenosis” (NCT04160130) comparing the safety and efficacy of TAVI versus SAVR in women with severe symptomatic AS irrespective of surgical risk.
The RHEIA trial was an international, multicenter, prospective randomized, parallel-controlled, open-label trial of female patients with severe AS designed to compare the use of a third-generation balloon-expandable TAVI to SAVR. The trial enrolled females patients with severe AS as defined by high aortic valve gradients or low gradient severe AS with confirmation by dobutamine stress echocardiography and/or aortic valve calcium score in addition to evidence of symptoms as defined by NYHA Functional Class ≥ II or symptoms on exercise testing. Key exclusion criteria included acute myocardial infarction 30 days prior to randomization, unicuspid/bicuspid/non-calcified aortic valve, severe aortic regurgitation, any concomitant valve requiring intervention, and complex coronary artery disease. The primary outcome was a composite clinical safety/efficacy endpoint comprising all-cause mortality, stroke, and re-hospitalization for valve or procedure-related symptoms or worsening heart failure at 1-year post-procedure.
A total of 443 patients were enrolled with a mean age of 73 patients. The mean Society of Thoracic Surgeons risk score was 2.1-2.2%. The incidence of the primary composite endpoint was significantly lower in the TAVI group compared to the SAVR group (8.9% vs. 15.6%, hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.34-0.88, p=0.03) and criteria was met for both non-inferiority and superiority. The difference in primary endpoints was driven primarily by a reduction in rehospitalization for valve- or procedure-related symptoms or worsening heart failure (4.8% in the TAVI group vs. 11.4% in the SAVR group, absolute difference of -6.6%, 95% CI: -11.9% to -1.4%, p=0.02). TAVI was associated with a lower incidence of new-onset atrial fibrillation than surgery at 1 year (3.3% vs. 28.8%; p<0.001) and shorter median length of index hospital stay (4 days vs. 9 days), but notably, TAVI was associated with higher rates of new permanent pacemaker implantation compared to the SAVR group (8.8% vs. 2.9%, p=0.01).
Dr. Eltchaninoff concluded: “In this first dedicated randomized TAVI trial in women, we were able to confirm its superiority over surgery, particularly with respect to reducing rehospitalizations. 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.”
