TRISCEND II
Trial question
What is the role of transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
76.0% female
24.0% male
N = 392
392 patients (296 female, 96 male).
Inclusion criteria: patients with severe symptomatic tricuspid regurgitation.
Key exclusion criteria: tricuspid valve anatomic contraindications; need for emergent or urgent surgery or any planned cardiac surgery within next 12 months; hemodynamic instability; refractory HF requiring advanced intervention.
Interventions
N=259 valve replacement (transcatheter tricuspid valve replacement and medical therapy).
N=133 medical therapy (medical therapy alone).
Primary outcome
A hierarchical composite of death, implantation of right ventricular assist device or heart transplantation, postindex tricuspid valve intervention, hospitalization for heart failure, improvement in Kansas City Cardiomyopathy Questionnaire overall summary of ≥ 10 points, improvement in New York Heart Association functional class of ≥ 1 point, improvement of at least 30 minutes on 6 minutes walk distance at 1 year
62.1%
30.7%
62.1 %
46.6 %
31.1 %
15.5 %
0.0 %
Valve
replacement
Medical
therapy
Significant
increase ▲
NNT = 3
Significant increase in a hierarchical composite of death, implantation of RV assist device or heart transplantation, postindex tricuspid valve intervention, hospitalization for HF, improvement in Kansas City Cardiomyopathy Questionnaire overall summary of ≥ 10 points, improvement in NYHA functional class of ≥ 1 point, improvement of at least 30 minutes on the 6 minutes walk distance at 1 year (62.1% vs. 30.7%; WR 2.02, 95% CI 1.56 to 2.62).
Secondary outcomes
Significant increase in tricuspid regurgitation reduction to ≤ moderate at 6 months (98.8% vs. 21.6%; AD 77.1%, 95% CI 31.35 to 122.85).
Safety outcomes
No significant differences in death from any cause, death from cardiovascular cause.
Significant differences in severe bleeding at 1 year (15.4% vs. 5.3%), arrhythmia and conduction disorder resulting in permanent pacing (17.8% vs. 2.3%).
Conclusion
In patients with severe symptomatic tricuspid regurgitation, valve replacement was superior to medical therapy with respect to a hierarchical composite of death, implantation of RV assist device or heart transplantation, postindex tricuspid valve intervention, hospitalization for HF, improvement in Kansas City Cardiomyopathy Questionnaire overall summary of ≥ 10 points, improvement in NYHA functional class of ≥ 1 point, improvement of at least 30 minutes on the 6 minutes walk distance at 1 year.
Reference
Rebecca T Hahn, Raj Makkar, Vinod H Thourani et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025 Jan 9;392(2):115-126.
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