Transcatheter tricuspid valve repair added to medical therapy reduced mortality and heart failure hospitalization in high-risk patients with symptomatic severe tricuspid regurgitation in the randomized
TRIC-I-HF trial.
Severe tricuspid regurgitation can cause enlargement of the right side of the heart and is associated with fatigue, dyspnea, fluid overload, and increased mortality. TRIC-I-HF enrolled patients with advanced disease and an increased risk of future heart failure events, defined by a heart failure hospitalization during the previous year, cardiorenal syndrome, or evidence of cardiohepatic syndrome.
The study randomized 360 patients at 29 high-volume heart valve centers in Germany: 237 to transcatheter repair plus medical therapy and 123 to medical therapy alone. Mean age was 80.3 years, and 56.4% were women. Of the patients who underwent an intervention, 98% were treated with tricuspid transcatheter edge-to-edge repair.
At 1 year, the first primary endpoint—a composite of all-cause mortality, heart failure hospitalization, and failure to achieve quality-of-life improvement—favored transcatheter repair, with a win ratio of 2.42 (P<.001). At 3 years, freedom from the co-primary endpoint of all-cause death or heart failure hospitalization was 52.4% with repair and 21.0% with medical therapy alone (hazard ratio, 0.40; P<.001). The difference reflected reductions in both all-cause mortality and heart failure hospitalization.
The investigators described the early and pronounced separation of the event curves as evidence of an immediate and sustained benefit in this advanced population. The results may be used to inform future guidelines.