Tricuspid Transcatheter Edge-to-Edge Repair Plus Optimized Medical Therapy efficacious in Severe Symptomatic Tricuspid Regurgitation: Study
A new trial found that tricuspid transcatheter edge-to-edge repair (T-TEER) and optimized medical therapy (OMT) enhanced the composite clinical outcomes at 12 months in individuals with symptomatic tricuspid regurgitation. The trial results were published in the journal JAMA Network.
Individuals with tricuspid regurgitation often experience reduced quality of life and poor survival rates due to decreased cardiac output and frequent manifestations of heart failure. Owing to the history of regurgitation, surgery is rarely performed, which leaves the option of medical management. Previous research has shown that Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a safe and effective therapy for reducing tricuspid regurgitation. As it has demonstrated the benefits of lowering the regurgitation rates and improving quality of life, researchers from France conducted a study to evaluate T-TEER combined with optimized medical therapy (OMT) vs OMT alone in patients with severe, symptomatic tricuspid regurgitation.
An investigator-initiated prospective, randomized clinical trial was carried out at 24 centers in France and Belgium. Patients were randomized 1:1 to receive T-TEER + OMT or OMT alone. The primary outcome was a composite clinical endpoint at 1 year comprising a change in New York Heart Association class (NYHA), change in patient global assessment (PGA), or occurrence of major cardiovascular events. Tricuspid regurgitation severity was the first of 6 secondary outcomes evaluated in a hierarchical closed-testing procedure. This included the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, patient global assessment, and a composite outcome of all-cause death, tricuspid valve surgery, KCCQ score improvement, or time to hospitalization for heart failure.
Findings:
- Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women), 152 were allocated to T-TEER + OMT and 148 to OMT alone.
- At 1 year, 109 patients (74.1%) in the T-TEER + OMT group had an improved composite score compared with 58 patients (40.6%) in the OMT-alone group.
- Massive or torrential tricuspid regurgitation was found in 6.8% of patients in the T-TEER + OMT group and 53.5% of those in the OMT-alone group (P < .001).
- Mean overall KCCQ summary score at 1 year was 69.9 (SD, 25.5) for the T-TEER + OMT group and 55.4 (SD, 28.8) for the OMT-alone group (P < .001).
- The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) (P < .001).
Thus, the study concluded that the combination of T-TEER + OMT enhanced composite clinical outcomes like the NYHA class, PGA, and major cardiovascular events in 1 year. This has significantly reduced tricuspid regurgitation and hence can be used as an effective intervention option for treating it.
Further reading: Donal E, Dreyfus J, Leurent G, et al. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. JAMA. Published online November 27, 2024. doi:10.1001/jama.2024.21189.
