Transcatheter vs. surgical aortic valve replacement in women: the RHEIA trial.

Summary

In a women-only, multicenter randomized trial, TAVI reduced the 1-year composite of death, stroke, or rehospitalization compared with surgery (8.9% vs 15.6%), meeting non-inferiority and achieving superiority. All-cause death (0.9% vs 2.0%) and rehospitalization (5.8% vs 11.4%) were lower with TAVI, while stroke rates were similar.

Key Findings

• Primary composite endpoint at 1 year: 8.9% with TAVI vs 15.6% with surgery; TAVI met non-inferiority and achieved superiority.
• All-cause mortality: 0.9% (TAVI) vs 2.0% (surgery); rehospitalization: 5.8% vs 11.4%; stroke: 3.3% vs 3.0%.
• Randomized across 48 European centers; mean age 73 years; low surgical risk (STS ~2.1%).

Clinical Implications

For women with severe aortic stenosis and low surgical risk, TAVI should be strongly considered as a first-line strategy given superior 1-year composite outcomes and reduced rehospitalization.

Limitations

• As-treated analysis rather than strict intention-to-treat may bias estimates
• Follow-up limited to 1 year; longer-term durability and valve-related outcomes pending

Future Directions

Extend follow-up to 5–10 years to assess valve durability, structural valve deterioration, pacemaker rates, and quality-of-life; evaluate outcomes across broader surgical risk profiles.