Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation
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Discussion
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Implication
Randomized trial demonstrates improved clinical outcomes with transcatheter edge-to-edge repair in severe tricuspid regurgitation, indicating substantial benefits over medical therapy alone.
Key Points
- To evaluate the efficacy and clinical outcomes of transcatheter edge-to-edge repair added to optimized medical therapy versus medical therapy alone in patients with severe, symptomatic tricuspid regurgitation.
- Investigator-initiated, multicenter, randomized (1:1) clinical trial conducted at 24 centers across France and Belgium with 1-year follow-up (ClinicalTrials.gov: NCT04646811).
- Randomized 300 adult patients with severe, symptomatic tricuspid regurgitation to transcatheter edge-to-edge repair plus optimized medical therapy (n=152) or medical therapy alone (n=148).
- Evaluated a primary composite clinical endpoint at 1 year consisting of change in New York Heart Association functional class, patient global assessment, or major cardiovascular events.
- At 1 year, 74.1% of patients (109/147) in the repair group achieved primary composite clinical score improvement compared with 40.6% (58/143) in the medical therapy alone group.
- Massive or torrential tricuspid regurgitation persisted in 6.8% of patients in the repair group versus 53.5% receiving medical therapy alone (P < .001).
- Repair significantly improved mean 1-year Kansas City Cardiomyopathy Questionnaire summary scores (69.9 vs 55.4; P < .001), yielding a win ratio of 2.06 (95% CI, 1.38-3.08; P < .001) for hierarchical composite outcomes.
Cite This Study
Donal et al. (2024) studied this question.