TRI-FR Trial: Tricuspid Repair Sustains Benefit at Two Years

Patients with severe tricuspid regurgitation often present with symptoms of right heart failure, including peripheral edema, ascites, and fatigue, significantly impacting quality of life.¹ Medical therapy primarily focuses on symptom management, but does not address the underlying valvular dysfunction. Surgical tricuspid valve repair or replacement is an option, but is frequently deferred due to the high surgical risk associated with advanced age, comorbidities, and often concomitant left-sided heart disease.² This clinical gap has driven the development of less invasive transcatheter approaches.

The TRI-FR Trial: Two-Year Outcomes

The TRI-FR trial was a prospective, multicentre, randomised study designed to evaluate the safety and efficacy of transcatheter tricuspid repair in patients with severe symptomatic tricuspid regurgitation who were deemed unsuitable for surgery.¹ The trial enrolled 300 patients across 25 centres, randomising them to either transcatheter repair or optimal medical therapy.¹ The primary endpoint was a composite of all-cause mortality, hospitalisation for heart failure, or repeat tricuspid intervention at one year. Secondary endpoints included changes in TR severity, functional status as assessed by New York Heart Association (NYHA) functional class, and quality of life metrics. The two-year outcomes presented at ACC.26 focused on the durability of the repair and sustained clinical benefits.

At two years, the trial demonstrated sustained reduction in tricuspid regurgitation severity.³ Specifically, 78% of patients in the transcatheter repair arm maintained TR severity at moderate or less, compared to 22% in the medical therapy arm (p<0.001).³ This reduction was associated with a significant improvement in NYHA functional class. At two years, 65% of patients in the intervention group were in NYHA class I or II, compared to 30% in the medical therapy group (p<0.001).³ The rate of hospitalisation for heart failure was also significantly lower in the transcatheter repair group, with an event rate of 18% compared to 35% in the medical therapy group (Hazard Ratio: 0.45, 95% CI: 0.28-0.72, p=0.001).⁴ All-cause mortality did not show a statistically significant difference between the groups at two years (15% vs 19%, p=0.32).⁴ The incidence of major adverse events related to the procedure remained low, consistent with the one-year findings, with no new safety concerns identified.³ Device success, defined as successful device implantation and reduction of TR by at least one grade, was achieved in 95% of patients.¹

These two-year results reinforce the durability and clinical benefit observed at one year, providing further evidence for transcatheter tricuspid repair as a viable treatment option. The sustained reduction in TR severity and improvement in functional status are particularly relevant for a patient population often limited by severe symptoms. The absence of a cross-over design in the trial means that patients initially randomised to medical therapy did not receive the intervention, providing a clear comparison of outcomes.¹ While the trial did not show a mortality benefit, the significant reduction in heart failure hospitalisations and improvement in quality of life are important clinical outcomes for this patient group. Further long-term follow-up will be essential to fully understand the sustained impact on survival and the potential for late complications.