Premium
Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years
Author(s) -
Iung Bernard,
Armoiry Xavier,
Vahanian Alec,
Boutitie Florent,
Mewton Nathan,
Trochu JeanNoël,
Lefèvre Thierry,
MessikaZeitoun David,
Guerin Patrice,
Cormier Bertrand,
Brochet Eric,
Thibault Hélène,
Himbert Dominique,
Thivolet Sophie,
Leurent Guillaume,
Bonnet Guillaume,
Donal Erwan,
Piriou Nicolas,
Piot Christophe,
Habib Gilbert,
Rouleau Frédéric,
Carrié Didier,
Nejjari Mohammed,
Ohlmann Patrick,
Saint Etienne Christophe,
Leroux Lionel,
Gilard Martine,
Samson Géraldine,
Rioufol Gilles,
MaucortBoulch Delphine,
Obadia Jean François
Publication year - 2019
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.1616
Subject(s) - medicine , heart failure , mitral regurgitation , hazard ratio , ejection fraction , cardiology , percutaneous , mitral valve , mitral valve repair , surgery , confidence interval
Abstract Aims The MITRA‐FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline‐directed medical treatment alone. We report the 24‐month outcome from this trial. Methods and results At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm 2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all‐cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all‐cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77–1.34]. All‐cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70–1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72–1.30). Conclusions In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.