Key Points:
- The TRI.FR trial found that tricuspid transcatheter edge-to-edge repair (T-TEER) together with optimal medical therapy significantly improved the clinical outcomes and reduced tricuspid regurgitation severity compared to optimal medical therapy alone.
- Patient-reported outcomes, including quality of life, were significantly better in the T-TEER group than in the control group.
- The trial underscores the importance of a multidisciplinary approach to treating tricuspid regurgitation, integrating T-TEER with guideline-directed medical management.
Long denoted the “Forgotten Valve,” the tricuspid valve has in recent years gained renewed interest. Traditionally, surgical treatment has been recommended for treatment of severe symptomatic tricuspid regurgitation (TR) or when the tricuspid annulus is found to be dilated prior to left heart surgery. More recently, a percutaneous tricuspid transcatheter edge-to-edge repair (T-TEER) option in the form of the TriClip was shown in the TRILUMINATE trial to be safe and effective at reducing TR by at least one grade but there remains a need for a trial comparing the TriClip to best medical therapy. In a breaking presentation at the 2024 ESC Congress today, Dr. Erwan Donal (Hospital of Rennes, France) and his team presented their study “TRI.FR: Multicentric Randomised Evaluation of the Transcatheter Edge-to-Edge Repair in the Treatment of Severe Isolated Secondary Tricuspid Regurgitation.”
The TRI.FR trial (NCT0464811) was an international, multicenter, prospective, randomized parallel, open label trial designed to compare T-TEER in addition to optimal medical therapy to optimal medical therapy alone for the treatment of functional TR (FTR). Key exclusion criteria included prior treatment with the MitraClip device in the prior 3 months, tricuspid valve anatomy unsuitable for TriClip implantation, cardiac rhythm device lead preventing appropriate placement of TriClip, left ventricular ejection fraction ≤35%. The primary outcome was the Milton Packer clinical composite score which classifies patients into one of three categories: improved, worsened, unchanged, based on aggregating functional evaluation using NYHA class, quality of life score via global patient assessment and a number of major cardiovascular events.
A total of 300 patients were enrolled from 24 centers in France and Belgium and randomized between T-TEER and optimal medical therapy. The mean age was 78 years and 54% were women. In total, 40% had been hospitalised for heart failure within 1 year before enrolment, and 15% had a cardiac implantable electronic device. Rates of the composite score endpoint were higher in the T-TEER group (74.1%) than in the control group (40.6%) in a statistically significant fashion (p<0.0001). After 1 year, the severity of TR significantly improved in the T-TEER group compared to the optimal medical therapy group (HR 0.73, 95% CI 0.68-0.78, p<0.0001). Patient-reported outcomes improved to a greater degree in the T-TEER group compared to the optimal medical therapy group, with the overall Kansas City Cardiomyopathy Questionnaire score at 1-year follow-up of 69.9 in the T-TEER group compared to 55.4 in the medical therapy group (p<0.0001).
Dr. Donal concluded by highlighting the importance of a multidisciplinary global approach to the treatment of TR: “We clearly showed the benefits of T-TEER as seen in the TRILUMINATE trial, by using T-TEER as part of a global approach and treating heart failure with guideline-directed medical management and follow-up. A key message of the TRI.FR trial is that implementing rigorous multidisciplinary medical management resulted in a low event rate, even in very ill patients with secondary TR.”