Key Points:
- There have been limited data examining the safety and efficacy of transcatheter tricuspid repair systems.
- In the TRILUMINATE study, Tri-Clip was compared against medical therapy in patients with severe symptomatic TR.
- Tri-Clip implantation reduced severity of TR and improved quality of life. Tri-Clip was safe and resulted in only a 1.7% rate of major adverse events.
Tricuspid regurgitation (TR) is associated with considerable symptom burden and morbidity, and many patients with severe TR do not qualify for surgical intervention. While several transcatheter tricuspid therapies have been developed, there has yet to be a large-scale RCT evaluating their safety and efficacy. In a breaking presentation at the 2023 ACC Conference today, Dr. Paul Sorajja (Minneapolis Heart Institute) and his team presented their study: “A Landmark Randomized Clinical Trial of Transcatheter Repair for Tricuspid Regurgitation,” or the TRILUMINATE trial.
The TRILUMINATE pivotal study (NCT03904147) was a multi-center randomized clinical trial conducted across 75 sites in the USA, Canada and Europe which evaluated the effects of the TriClip system in patients with TR. The inclusion criteria comprised any adults with severe symptomatic TR on stable GDMT for at least a 1 month and at least an intermediate risk of mortality/morbidity with tricuspid valve surgery. The exclusion criteria included: indication for another valve intervention, severe pulmonary hypertension, LVEF <20%, or unsuitable anatomy.
A total of 350 patients were randomized. The average age was 78, and 55% were women. 57% were NYHA III or IV at baseline. 75% of participants had massive or torrential TR. The primary outcome was composite of mortality or tricuspid valve surgery, heart failure hospitalizations, and quality of life improvement ≥15 points assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), evaluated at 12 months in a hierarchical fashion using the Finkelstein-Schoenfeld methodology. Secondary endpoints hierarchically included a) freedom from major adverse events (MAE) after procedure attempt (femoral vein puncture) at 30 days (Device group only), b) change in KCCQ at 12 months (superiority of Device vs. Control), c) TR Reduction to moderate or less at 30-day post procedure (superiority of Device vs. Control), and d) change in 6MWD at 12 months (superiority of Device vs. Control) 15-year MACE (CV mortality, AMI, and revascularization). For the primary endpoint, TriClip therapy demonstrated superiority to medical therapy largely driven by improvement in KCCQ (Win ratio, 1.48 (1.06, 2.13), p=0.02). At 30 days, 87% of Tri-Clip patients no longer had severe TR (p<0.0001 relative to control). On individual component analysis, there was no significant difference in HF hospitalization, mortality or TV surgery. On secondary endpoint analysis, patients receiving Tri-Clip had improved freedom from MAE through 30 Days post procedure and change in KCCQ from baseline to 12 months (p<0.001). Tri-Clip therapy was safe, with only a 1.7% rate of MAE.
When discussing the clinical implications of the study at ACC, Dr. Sorajia stated: “TRILUMINATE Pivotal is a pioneering study as the first RCT in this unique population of patients with severe TR. The TriClip device was highly effective in reducing TR and led to significant improvements in quality of life at one year, without the high procedural risk often associated with tricuspid surgery…with the excellent benefit-to-risk profile of the TriClip system, a historically untreated population will have a treatment option to improve their quality of life.”