Randomised controlled trial
Transcatheter Repair for Patients with Tricuspid Regurgitation
- Randomised controlled trial
- prospective
- multicentre (65 centres, US, Canada, Europe)
- 1:1 randomisation
Authors' conclusion
Tricuspid TEER was safe for patients with severe tricuspid regurgitation, reduced the severity of tricuspid regurgitation, and was associated with an improvement in quality of life.
Study context
- Population
- Patients with symptomatic severe tricuspid regurgitation
- Participants
- 350 patients
- Comparison
- Tricuspid transcatheter edge-to-edge repair (TEER) vs medical therapy
- TEERn = 175
- Controln = 175reference
- Primary endpoint
- Hierarchical composite:
- Death from any cause or tricuspid-valve surgery
- HF hospitalisation
- Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement ≥15 points
- Follow-up
- 1 year
Primary result
Hierarchical composite primary end point
Win ratio
1.48
95% CI 1.06–2.13
P = 0.02
TEER vs Control
win ratio 1.48 (95% CI 1.06–2.13); P = 0.02
As reported in the abstract
Further findings
Change in KCCQ score
P < 0.001
Tricuspid regurgitation no greater than moderate · 30 days
P < 0.001
Death or tricuspid-valve surgery; HF hospitalisation
- Did not appear to differ between the groups
Safety
- Freedom from major adverse events (patients who underwent TEER) · 30 days
- 98.3%
Original publication
Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. Published 4 March 2023. doi:10.1056/nejmoa2300525
Summarised from the published abstract; every number is checked against it