- Design
- multicentre randomised trial, 2:1, transcatheter repair plus medical therapy versus medical therapy alone (TRIC-I-HF)
- Population
- 360 patients with symptomatic severe tricuspid regurgitation at raised risk of heart-failure events; mean age 80.3 years, 56.4% women
- Primary outcome
- hierarchical composite of death, heart-failure hospitalisation and quality-of-life improvement at 1 year (win ratio), then death or heart-failure hospitalisation through 3 years
- Effect
- win ratio 2.42 (95% CI 1.76-3.33), P<0.001; 3-year freedom from death or HF hospitalisation 52.4% vs 21.0%, HR 0.40 (95% CI 0.29-0.55)
TRIC-I-HF randomised 360 patients with symptomatic severe tricuspid regurgitation and a raised risk of future heart-failure events, 2:1, to transcatheter tricuspid-valve repair plus medical therapy or medical therapy alone. The population was old and mostly female: mean age 80.3 years, 56.4% women. The first primary endpoint was a hierarchical composite of death from any cause, heart-failure hospitalisation and quality-of-life improvement at one year, judged by win ratio; the second, tested only if the first was significant, was death or heart-failure hospitalisation through three years.
Both were met. The win ratio was 2.42 (95% CI 1.76 to 3.33). At three years, freedom from death or heart-failure hospitalisation was 52.4% with repair and 21.0% with medical therapy alone, hazard ratio 0.40 (95% CI 0.29 to 0.55). Major adverse events within 30 days occurred in 5.9% of the repair group.
This matters because earlier tricuspid device trials moved symptoms and regurgitation grade while leaving death and admission untouched, which is why severe tricuspid regurgitation has so often been managed as a diuretic problem. A halving of the hazard for a hard composite changes what can honestly be offered to an eighty-year-old with refractory right-sided congestion.
In clinic, the finding argues for identifying these patients rather than waiting for them to declare themselves. The trial enrolled on symptoms plus a raised risk of heart-failure events, not on regurgitation grade alone, so the reasonable trigger for a structural referral is the patient whose congestion keeps returning despite escalating diuretics. Note the softest part of the result: the quality-of-life component sits inside a comparison of a procedure against medical therapy alone, and should not carry the same weight as the mortality and admission data behind it.
- In recurrent right-sided congestion, grade the tricuspid valve deliberately rather than reporting it as an incidental finding
- Record what the patient is actually taking: the comparison is against medical therapy, so document diuretic dose and adherence before calling it refractory
- Assess right ventricular function and pulmonary pressures, which decide whether repair is technically sensible
- Set expectations on the 30-day risk: about 1 in 17 had a major adverse event within a month
- Device availability and funding vary widely between Indian centres; confirm both before raising the option with a family
The statistics, in plain English
A hazard ratio of 0.40 means the rate of death or heart-failure admission was about 60% lower with repair, and the confidence interval (0.29 to 0.55) sits entirely well below 1.0, so chance is an implausible explanation. The win ratio of 2.42 says that when any two patients from opposite groups were compared in order of severity, the repair patient did better about 2.4 times as often as worse. Win ratios are dominated by whichever event comes first in the hierarchy, here death, which is reassuring; the quality-of-life tier contributes least reliably in a trial where one group had a procedure and the other did not.
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