- Question
- Is a mechanically expanded transcatheter aortic valve (Lotus) noninferior to a self-expanding valve (CoreValve) in high-risk patients with aortic stenosis?
- Design
- Randomized, open-label (unmasked), noninferiority trial with 2:1 allocation, enrolling 912 patients at 55 centers in North America, Europe and Australia; main follow-up at 1 year.
- Population
- Patients with severe symptomatic aortic stenosis at high or extreme surgical risk (mean age 82.8 years, 51% women, predicted mortality 6.8%).
- Intervention
- Transcatheter aortic valve replacement with the mechanically expanded Lotus valve (607 patients).
- Control
- Transcatheter aortic valve replacement with the self-expanding CoreValve/Evolut R valve (305 patients).
- Primary outcome
- Safety: 30-day composite of all-cause mortality, stroke, life-threatening or major bleeding, stage 2/3 acute kidney injury and major vascular complications. Effectiveness: 1-year composite of all-cause mortality, disabling stroke and moderate or greater paravalvular leak.
- Results
- The 30-day safety endpoint occurred in 20.3% with Lotus and 17.2% with CoreValve (difference 3.1%; P = .003 for noninferiority). The 1-year effectiveness endpoint occurred in 15.4% vs 25.5% (difference -10.1%; P<.001 for noninferiority), with significant superiority. Moderate or severe paravalvular leak at 1 year was 0.9% vs 6.8% (P < .001).
- Safety
- Lotus had more new pacemaker implants (35.5% vs 19.6%; P < .001) and valve thrombosis (1.5% vs 0%), but fewer repeat procedures (0.2% vs 2.0%), valve-in-valve deployments (0% vs 3.7%) and valve malpositioning (0% vs 2.7%).
- Conclusion
- In high-risk patients, the mechanically expanded valve was noninferior to the self-expanding valve on safety and effectiveness endpoints, with less paravalvular leak but more pacemaker implantation.
- Why it matters
- It showed that a repositionable, mechanically expanded valve was a viable TAVR alternative, reducing paravalvular leak at the cost of a higher need for pacemakers.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 15, 2026