TRICuspid Intervention in Heart Failure trial (TRIC-I-HF-DZHK24)

doi:10.1056/nejmoa2606934

TRIC-I-HF

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 360 patients with severe tricuspid regurgitation and right heart failure, transcatheter tricuspid intervention reduced death, heart-failure hospitalisation and quality of life at 12 months compared with medical therapy alone.

N

360pazienti

Disegno

investigator-initiated, prospective, multicentre (29 German sites), open-label, randomised strategy trial; 2:1 transcatheter tricuspid valve intervention plus OMT vs OMT alone; hierarchical primary endpoints at 12 months; total follow-up 3 years

Esito

first primary: hierarchical composite of all-cause mortality, heart failure hospitalisation and quality-of-life improvement at 12 months (win ratio); second primary (tested if first positive): time to all-cause death or heart failure hospitalisation

Rilevanza

1Definisce la pratica — lo studio su cui poggia la linea guida.

RisultatoWin ratio 2.42 (95% CI 1.76-3.33; P < 0.001) at 12 months for the hierarchy of death, heart failure hospitalisation and quality-of-life improvement. At three years, freedom from death or heart failure hospitalisation 52.4% vs 21.0% (HR 0.40, 95% CI 0.29-0.55; P < 0.001), with both components reduced.

Hausleiter J, Stocker TJ, et al. N Engl J Med. 2026; published online 30 August. 10.1056/nejmoa2606934

Discussione e critica

Tricuspid intervention has until now bought symptoms and quality of life; this is the first trial to move death and heart failure hospitalisation, and it does so by a wide margin in a group with a mean age of 80. Two features earn caution rather than doubt: the allocation is roughly 2:1 towards the device, and the trial is open-label, so the quality-of-life tier of the win ratio carries whatever expectation an implanted patient has. The three-year hard endpoint does not have that problem, and it is where the case rests.