Two-year Outcomes of Transcatheter Edge-to-edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Trial.

Abstract

Background: One-year outcomes of the TRILUMINATE Pivotal trial found that transcatheter edge-to-edge repair (TEER) for the treatment of severe, symptomatic tricuspid regurgitation (TR) improved quality-of-life compared with medical therapy alone with similar rates of mortality and heart failure hospitalization (HFH). However, additional follow-up is necessary to determine prolonged benefits of tricuspid TEER.

Methods: A total of 572 patients with severe, symptomatic TR were randomized to either tricuspid TEER+medical therapy (Device) or medical therapy alone (Control). Two-year prespecified endpoints were (1) recurrent HFH and (2) freedom from all-cause mortality, tricuspid valve surgery and tricuspid valve intervention post treatment visit, assessed in the intention-to-treat population.

Results: The annualized rate of recurrent heart failure hospitalizations through 2 years was significantly lower with tricuspid TEER compared with Control (0.19 vs 0.26 events/patient-year, p=0.02; joint frailty model hazard ratio 0.72, one-sided upper confidence limit of 0.93, p=0.02). Freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention through 2 years was significantly higher with tricuspid TEER compared with Control (77.6% vs 29.3%, p<0.0001) driven by more tricuspid valve intervention in control patients crossing over to device treatment (3.8% vs. 61.5%). Rates of all-cause mortality (17.9% vs. 17.1%) and tricuspid valve surgery (2.3% vs. 4.3%) were similar between groups. Moderate-or-less TR was present in 84% at 2 years in the Device group.

Conclusions: At 2-year follow-up, tricuspid TEER appears safe, significantly reduced TR severity, and decreased rates of HFH compared with medical therapy alone.