Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal - TRILUMINATE Pivotal
Contribution To Literature:
Highlighted text has been updated as of October 26, 2023.
The TRILUMINATE Pivotal trial showed that tricuspid valve TEER was effective and improved quality of life.
The goal of the trial was to evaluate percutaneous tricuspid valve transcatheter edge-to-edge repair (TEER) compared with medical therapy among patients with symptomatic severe tricuspid regurgitation.
Patients with symptomatic severe tricuspid regurgitation were randomized to tricuspid valve TEER (n = 175) vs. usual care (n = 175).
- Total number of enrollees: 350
- Duration of follow-up: 12 months
- Mean patient age: 78 years
- Percentage female: 56%
- Percentage with diabetes: 16%
- Symptomatic severe tricuspid regurgitation
- New York Heart Association class II, III, IVa symptoms
- Receiving stable guideline-directed medical therapy for heart failure for ≥30 days
- Intermediate or greater risk for mortality/morbidity with tricuspid valve surgery
- Indication for other valve intervention
- Severe pulmonary hypertension >70 mm Hg
- Left ventricular ejection fraction ≤20%
- Anatomy not suitable for TEER therapy
Other salient features/characteristics:
- Coaptation gap: 5.5 mm
- Tricuspid regurgitation severity: severe = 25%, massive = 21%, torrential = 51%
The primary outcome, hierarchical composite of death from any cause or tricuspid valve surgery; hospitalization for heart failure; and improvement in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months, had 11,348 wins in the TEER group versus 7,643 wins in the usual care group (win ratio = 1.48, p = 0.02).
- Tricuspid regurgitation of moderate or less severity at 30 days: 87.0% in the TEER group vs. 4.8% in the usual care group (p < 0.001)
- Change in KCCQ score from baseline to 12 months: 12.3 in the TEER group vs. 0.6 in the usual care group (p < 0.001)
- Mean increase in KCCQ score: 2 points when no change in tricuspid regurgitation (from baseline to 12 months), 6 points when 1 grade reduction in tricuspid regurgitation, and 18 points when ≥2 grade reduction in tricuspid regurgitation
- Major adverse events at 30 days: 1.7% in the TEER group
- Tricuspid-edge-to-edge transcatheter valve repair (T-TEER) vs. medical therapy was associated with a 10.4-point increase in KCCQ-overall summary score (KCCQ-OS) at 12 months
- Alive with a large improvement in health status (KCCQ-OS ≥20 points): 42% with T-TEER vs. 16% with medical therapy (p < 0.001)
- Alive and well (KCCQ-OS ≥60 points and no decline of >10 points): 75% with T-TEER vs. 46% with medical therapy (p < 0.001)
- Change in KCCQ-OS per 1 grade improvement in tricuspid regurgitation severity: 4.2 (p = 0.001)
- Death or heart failure hospitalization with 10-point increase in KCCQ-OS; hazard ratio 0.74 (p < 0.001)
Among patients with symptomatic severe tricuspid regurgitation, TEER was effective. This therapy improved tricuspid regurgitation to moderate or less severity in 87% of patients. Reduction in tricuspid regurgitation was associated with improvements in symptoms, functional status, and quality of life. The largest increase in KCCQ was observed among those with the largest reduction in tricuspid regurgitation. Exploratory analyses suggested that health status benefit of T-TEER may be explained by tricuspid regurgitation reduction. Improvement in health status was associated with reduction in 1-year mortality and heart failure hospitalization. Patients enrolled in this trial will be followed for 5 years.
Arnold SV, Goates S, Sorajja P, et al., on behalf of the TRILUMINATE Pivotal Trial Investigators. Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation: Results From the TRILUMINATE Pivotal Trial. J Am Coll Cardiol 2023;Oct 26:[Epub ahead of print].
Presented by Dr. Suzanne V. Arnold at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 26, 2023.
Presented by Dr. Paul Sorajja at the American College of Cardiology Annual Scientific Session (ACC.23/WCC), New Orleans, LA, March 4, 2023.
Keywords: Heart Valve Diseases, Structural Intervention, TCT23, Transcatheter Cardiovascular Therapeutics
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