2025Valve diseaseIntervention400 patients

TRISCEND II

Therapy group: Transcatheter tricuspid valve · Therapy: Transcatheter tricuspid valve replacement (EVOQUE) plus medical therapy vs medical therapy alone

In symptomatic severe tricuspid regurgitation, transcatheter valve replacement plus medical therapy improved the hierarchical composite outcome versus medical therapy alone, driven mainly by quality of life and functional class.

Published in N Engl J Med (2025)

Question: Does transcatheter tricuspid-valve replacement added to medical therapy improve outcomes compared with medical therapy alone in patients with severe symptomatic tricuspid regurgitation?
Design: International, multicenter, 2:1 randomized, open-label (per the registry) trial enrolling 400 patients, with the main assessment at 1 year.
Population: Patients with severe symptomatic tricuspid regurgitation.
Intervention: Transcatheter tricuspid-valve replacement with the EVOQUE system plus medical therapy (267 patients).
Control: Medical therapy alone (133 patients).
Primary outcome: Hierarchical composite analyzed with a win ratio: death from any cause, right ventricular assist device implantation or heart transplantation, postindex tricuspid-valve intervention, heart-failure hospitalization, and improvements in KCCQ-OS (≄10 points), NYHA class (≄1 class) and 6-minute walk distance (≄30 m).
Results: At 1 year, the win ratio favoring valve replacement was 2.02 (95% CI 1.56 to 2.62; P<0.001). Improvement in KCCQ-OS was the component with the largest difference (23.1% vs. 6.0% of wins), whereas all-cause death showed 14.8% vs. 12.5%.
Safety: Severe bleeding occurred in 15.4% of the valve-replacement group and 5.3% of controls (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001).
Conclusion: Transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven mainly by improvements in symptoms and quality of life.
Why it matters: It provided randomized evidence that percutaneous replacement of the tricuspid valve can improve how patients with severe tricuspid regurgitation feel and function, at the cost of more bleeding and pacemaker need. It opened a therapeutic option for a valve disease historically undertreated.

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 14, 2026

Sources

Original publication on PubMed (PMID 39475399) ↗Transcatheter Valve Replacement in Severe Tricuspid Regurgitation.
Journal article (DOI) ↗
ClinicalTrials.gov record (NCT04482062) ↗

Videos explaining it

TCT 2025: Insights from the TRISCEND Study and TRISCEND II Trial

PCR · PCR ↗3:51Video page

Source: PCR · YouTube
Date: 30 Oct 2025
Audio: English
Subtitles: MultilingualYouTube
Audio transl.: Unconfirmed · check ⚙YouTube

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