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Randomized Controlled Trial
. 2019 Dec;21(12):1619-1627.
doi: 10.1002/ejhf.1616. Epub 2019 Nov 18.

Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years

Bernard Iung  1   2 , Xavier Armoiry  3 , Alec Vahanian  2 , Florent Boutitie  4 , Nathan Mewton  5 , Jean-Noël Trochu  6 , Thierry Lefèvre  7 , David Messika-Zeitoun  1   8 , Patrice Guerin  6 , Bertrand Cormier  7 , Eric Brochet  1 , Hélène Thibault  9 , Dominique Himbert  1 , Sophie Thivolet  9 , Guillaume Leurent  10 , Guillaume Bonnet  11 , Erwan Donal  10 , Nicolas Piriou  6 , Christophe Piot  12 , Gilbert Habib  11 , Frédéric Rouleau  13 , Didier Carrié  14 , Mohammed Nejjari  15 , Patrick Ohlmann  16 , Christophe Saint Etienne  17 , Lionel Leroux  18 , Martine Gilard  19 , Géraldine Samson  5 , Gilles Rioufol  20 , Delphine Maucort-Boulch  4 , Jean François Obadia  21 ; MITRA-FR Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years

Bernard Iung et al. Eur J Heart Fail. 2019 Dec.
Free article

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 mm2 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.

Trial registration: ClinicalTrials.gov NCT01920698.

Keywords: Heart failure; Percutaneous mitral valve repair; Secondary mitral regurgitation.

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