Valvular & structural heart diseaseRandomised controlled trial
Transcatheter Valve Replacement in Severe Tricuspid Regurgitation
- Randomised controlled trial
- international
- multicentre
- 2:1 randomisation
Authors' conclusion
For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life.
Study context
- Population
- Patients with severe symptomatic tricuspid regurgitation
- Participants
- 400 patients
- Comparison
- Valve replacement vs Control
- Valve replacementn = 267
- Controln = 133reference
- Primary endpoint
- Hierarchical composite (win ratio): all-cause death, RV assist device or heart transplantation, postindex tricuspid-valve intervention, HF hospitalization, Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) improvement ≥10 points, New York Heart Association (NYHA) improvement ≥1 class, 6-minute walk distance improvement ≥30 m
- Follow-up
- 1 year
Primary result
As reported in the abstract
Win ratio
2.02
95% CI 1.56–2.62
P < 0.001
Valve replacement vs Control
win ratio 2.02 (95% CI 1.56–2.62); P < 0.001
Further findings
Wins by hierarchy component (patient pairs)
All-cause death
Postindex tricuspid-valve intervention
KCCQ-OS improvement
NYHA class
6-minute walk distance
Annualized HF hospitalization
Safety
Severe bleeding
P = 0.003
New permanent pacemaker
P < 0.001
Original publication
Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. Published 30 October 2024. doi:10.1056/nejmoa2401918
Summarised from the published abstract; every number is checked against it