Tricuspid-Valve Intervention in Heart Failure

BACKGROUND: The effect of transcatheter tricuspid-valve repair on clinical outcomes, including death and hospitalization for heart failure, in patients with severe tricuspid regurgitation remains uncertain. METHODS: We randomly assigned patients with symptomatic severe tricuspid regurgitation and an increased risk of future heart-failure events in a 2:1 ratio to tricuspid-valve repair plus medical therapy (tricuspid-repair group) or medical therapy alone (medical-therapy group). The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year, assessed by win ratio. If the between-group difference was significant, a second primary end point would be tested: a composite of death from any cause or hospitalization for heart failure through 3 years. RESULTS: A total of 360 patients underwent randomization (237 patients were assigned to the tricuspid-repair group and 123 to the medical-therapy group). The mean (±SD) age of the patients was 80.3±6.4 years, and 56.4% were women. The win ratio for the first primary end point was 2.42 (95% confidence interval [CI], 1.76 to 3.33; P