Severe tricuspid regurgitation (TR) is associated with chronic systemic venous congestion, recurrent hospitalizations for heart failure (HF), and a significant deterioration in quality of life. Previous trials with percutaneous therapies have demonstrated reductions in regurgitation and symptomatic improvement, although without a clear impact on hard endpoints in the short term. In this context, the TRI-FR study was designed to evaluate the longer-term clinical impact of edge-to-edge percutaneous repair (T-TEER) compared with optimal medical therapy (OMT) in patients with isolated severe TR.
This was a randomized, multicenter clinical trial with 1:1 allocation to T-TEER plus OMT versus OMT alone, including 300 patients across 24 centers (mainly in France). The mean age was 78 years, 64% were women, 95% had atrial fibrillation, 42% were in NYHA functional class III–IV, and 91% had massive or torrential TR, defining a phenotype of advanced right-sided heart failure.
This profile was not defined by a single score, but rather by a combination of high symptom burden, functional limitation (6MWT ~300 m), impaired quality of life (KCCQ ~54), and elevated biomarkers (NT-proBNP ~1500–1700 pg/mL), along with signs of moderate right-sided hemodynamic compromise (right atrial pressure ~9–10 mmHg and mean pulmonary pressure ~22 mmHg). Severe renal dysfunction (eGFR <30 mL/min/1.73 m²) was infrequent (4–8%). Optimal medical therapy was not strictly protocolized, but consisted of standard heart failure management according to guidelines.
A significant reduction in the primary endpoint (composite of time to first event of HF hospitalization, tricuspid surgery, or cardiovascular death) was observed in the T-TEER group, with a hazard ratio of 0.56 (p=0.0109), representing a 44% relative risk reduction. HF hospitalizations were lower in the intervention group (37 vs 64), with rates of 9.28 versus 16.5 events per 100 patient-years (p=0.0073). Likewise, the number of patients with at least one HF hospitalization was lower (27 vs 42), and a reduction in the need for tricuspid surgery was observed (1 vs 10). All-cause mortality was similar between groups (32 vs 30), with no significant differences in cardiovascular death.
Conclusion: T-TEER reduces major clinical events in isolated severe tricuspid regurgitation over long-term follow-up
In conclusion, the extended follow-up of the TRI-FR study demonstrates that in patients with isolated severe tricuspid regurgitation and a profile of advanced right-sided heart failure, edge-to-edge percutaneous repair combined with optimal medical therapy significantly reduces the risk of major clinical events, mainly driven by a sustained reduction in heart failure hospitalizations.
Original Title: Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: Extended Follow-up of the TRI-FR Trial.
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