Jean-François Obadia1, David Messika-Zeitoun1, Guillaume Leurent1, Bernard Iung1, Guillaume Bonnet1, Nicolas Piriou1, Thierry Lefèvre1, Christophe Piot1, Frédéric Rouleau1, Didier Carrié1, Mohammed Nejjari1, Patrick Ohlmann1, Florence Leclercq1, Christophe Saint Etienne1, Emmanuel Teiger1, Lionel Leroux1, Nicole Karam1, Nicolas Michel1, Martine Gilard1, Erwan Donal1, Jean-Noël Trochu1, Bertrand Cormier1, Xavier Armoiry1, Florent Boutitie1, Delphine Maucort-Boulch1, Cécile Barnel1, Géraldine Samson1, Patrice Guerin1, Alec Vahanian1, Nathan Mewton1. 1. From Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque (J.-F.O.), Pharmacy Department and Laboratoire Mateis (X.A.), and Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center and Heart Failure Department, INSERM 1407 (C.B., G.S., N. Mewton), Hospices Civils de Lyon and Claude Bernard University, Lyon, Assistance Publique-Hôpitaux de Paris (APHP), Hôpital Bichat (D.M.-Z., B.I., A.V.), and APHP, Hôpital Européen Georges Pompidou (N.K.), Paris, Centre Hospitalier Universitaire (CHU) Rennes, Hôpital Pontchaillou, Rennes (G.L., E.D.), Assistance Publique-Hôpitaux de Marseille (APHM), Hôpital de la Timone (G.B.), and Hôpital Saint Joseph (N. Michel), Marseille, CHU Nantes, Hôpital Guillaume et René Laennec, Nantes (N.P., J.-N.T., P.G.), Institut Jacques Cartier, Massy (T.L., B.C.), Clinique du Millénaire (C.P.) and CHU Montpellier, Hôpital Arnaud-de-Villeneuve (F.L.), Montpellier, CHU Angers, Angers (F.R.), CHU Toulouse, Hôpital Rangueil, Toulouse (D.C.), Centre Cardiologique du Nord, Saint-Denis (M.N.), Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg (P.O.), Centre Hospitalier Régional Universitaire (CHRU) de Tours, Hôpital Trousseau, Tours (C.S.E.), APHP, Hôpital Henri Mondor, Créteil (E.T.), CHU Bordeaux, Hôpital Haut-Lévêque, Pessac (L.L.), CHRU Brest, Hôpital de La Cavale Blanche, Brest (M.G.), and Service de Biostatistique-Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Centre National de la Recherche Scientifique (CNRS), and Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne (F.B., D.M.-B.) - all in France; and the University of Ottawa Heart Institute, Division of Cardiology, Ottawa, Canada (D.M.-Z.).
Abstract
BACKGROUND: 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. METHODS: 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 receivemedical therapy alone (controlgroup; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. RESULTS: 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). CONCLUSIONS: 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 .).
RCT Entities:
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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 .).
Authors: Annetine C Gelijns; Alan J Moskowitz; Patrick T O'Gara; Gennaro Giustino; Michael J Mack; Donna M Mancini; Emilia Bagiella; Judy Hung; Gorav Ailawadi; Martin B Leon; Michael A Acker; John H Alexander; Neal W Dickert; Wendy C Taddei-Peters; Marissa A Miller Journal: J Thorac Cardiovasc Surg Date: 2020-03-21 Impact factor: 5.209