Portal de Periódicos da CAPES

Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation

2018; Massachusetts Medical Society; Volume: 379; Issue: 24 Linguagem: Inglês

10.1056/nejmoa1805374

1533-4406

Jean‐François Obadia, David Messika‐Zeitoun, Guillaume Leurent, Bernard Iung, Guillaume Bonnet, Nicolas Piriou, Thierry Lefèvre, Christophe Piot, Frédéric Rouleau, Didier Carrié, M. Nejjari, Patrick Ohlmann, Florence Leclercq, Christophe Saint Etienne, Emmanuel Teíger, Lionel Leroux, Nicole Karam, Nicolas Michel, Martine Gilard, Erwan Donal, Jean‐Noël Trochu, Bertrand Cormier, Xavier Armoiry, Florent Boutitie, Delphine Maucort‐Boulch, Cécile Barnel, Géraldine Samson, Patrice Guérin, Alec Vahanian, Nathan Mewton,

Cardiac pacing and defibrillation studies

In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown.We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months.At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56).Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).