At the recent Transcatheter Therapeutics Scientific Sessions 2023, Dr. Kodali and investigators from the TRISCENDII Clinical Trial presented the six-month results for the first 150 patients enrolled in this important pivotal study. TRISCENDII is a large multicenter randomized trial comparing the safety and efficacy of transcatheter tricuspid valve replacement (TTVR, using the EVOQUE valve) combined with optimal medical therapy versus optimal medical therapy alone for patients with severe symptomatic tricuspid valve regurgitation. In this late-breaking landmark trial, the study achieved the co-primary effectiveness endpoints at 6 months, demonstrating the superiority of TTVR to medical therapy alone.
Notably, at 6 months, 98.8% of treated patients achieved < moderate tricuspid regurgitation (93.8% of < mild tricuspid regurgitation). Correspondingly, there were substantial improvements in the New York Heart Association Class, quality of life, and 6-minute walk test of patients treated with the EVOQUE valve in combination with medical therapy. At 30 days, major adverse event rate was 27.4%, and this was driven primarily by bleeding. The 1-year outcomes for the complete cohort of 400 patients are highly anticipated, and it is expected that the US FDA will convene in early calendar year 2024 to review the current data for both transcatheter tricuspid valve edge-to-edge repair and replacement.
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