TRI-FR (2-Year)
Transcatheter Tricuspid Edge-to-Edge Repair vs Medical Therapy for Severe Tricuspid Regurgitation: 2-Year Outcomes
Presented by Erwan Donal — CHU Rennes
Subspecialty: Valvular
Published in ACC.26 Late-Breaking
Key Result
T-TEER for severe TR reduced the primary endpoint from 35% to 20% at 2 years, with 40% fewer HF hospitalizations. No crossover in the control group — first unconfounded long-term T-TEER outcomes.
What did this trial find?
The TRI-FR trial's 2-year results showed that T-TEER for severe tricuspid regurgitation reduced the primary composite endpoint from 35% to 20% and HF hospitalizations by 40% (14% vs 23%), with no crossover in the control group—providing the first unconfounded long-term T-TEER outcomes. While 1-year results had shown quality-of-life benefits without hard endpoint separation, the 2-year data now demonstrate meaningful reductions in clinical events. There is some debate from the 1-year presentation about soft vs. hard endpoints, and the lack of blinding remains a noted limitation.
Why does this trial matter?
There is meaningful debate here. The 2-year results are a significant advancement over the 1-year data, which showed only soft endpoint benefits and drew sharp criticism from the ESC discussant (Ruschitzka) about performance bias in an open-label trial. The 2-year data now show hard endpoint reductions (HF hospitalization), and the unique absence of crossover strengthens the findings. However, direct coverage of the 2-year ACC.26 presentation is limited to the ACC summary article; most available expert commentary comes from the 1-year ESC 2024 presentation. The mortality question remains open pending 5-year follow-up.
Study Design
Multicenter, randomized, controlled trial across 24 centers in France and Belgium (N=300)
Clinical Implications
Provides the strongest unconfounded evidence for T-TEER in severe TR, with sustained 2-year benefits including fewer HF hospitalizations. 5-year follow-up planned to assess survival benefit and cost-effectiveness.
Abstract
The TRI-FR trial randomized 300 patients (average age 78, 63.7% women) with severe symptomatic tricuspid regurgitation across 24 centers in France and Belgium. 91% had extremely severe TR and 91% had atrial fibrillation. At 2 years, the primary endpoint was met in 20% of T-TEER patients vs 35% of standard care (40% reduction). HF hospitalizations were reduced by 40%: 14% of T-TEER vs 23% of standard care. Notably, no control group patients crossed over to receive T-TEER during follow-up, providing unconfounded long-term assessment. Risk of death, MI, and stroke were also reduced.