Valvular & structural heart diseaseRandomised controlled trial
Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial
- Randomised controlled trial
Authors' conclusion
At the 2-year follow-up, tricuspid TEER appeared safe, significantly reduced tricuspid regurgitation severity, and decreased rates of heart failure hospitalization compared with medical therapy alone.
Study context
- Population
- Patients with severe, symptomatic tricuspid regurgitation
- Participants
- 572 patients
- Comparison
- Tricuspid transcatheter edge-to-edge repair (TEER) + medical therapy vs medical therapy alone
- Primary endpoint
- Recurrent HF hospitalization; freedom from all-cause mortality, tricuspid valve surgery and tricuspid valve intervention after treatment visit (prespecified 2-year end points)
- Follow-up
- 2 years
Primary result
Recurrent HF hospitalization (annualized rate) · through 2 years
Hazard ratio
0.72
P = 0.02
By group
As reported in the abstract
Further findings
Freedom from all-cause mortality, tricuspid valve surgery and tricuspid valve intervention · 2 years · intention-to-treat
P < 0.0001
- Freedom from all-cause mortality, tricuspid valve surgery and tricuspid valve intervention: driven by tricuspid valve intervention in control patients crossing over to device (3.8% vs 61.5%)
All-cause mortality and tricuspid valve surgery · 2 years
- All-cause mortality similar between groups (device vs control)
- 17.9% vs 17.1%
- Tricuspid valve surgery similar between groups (device vs control)
- 2.3% vs 4.3%
Moderate or less tricuspid regurgitation (device group) · 2 years
- Moderate or less TR in the device group
- 84%
Original publication
Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial. Circulation. Published 30 March 2025. doi:10.1161/circulationaha.125.074536
Summarised from the published abstract; every number is checked against it