Bernard Iung1,2, Xavier Armoiry3, Alec Vahanian2, Florent Boutitie4, Nathan Mewton5, Jean-Noël Trochu6, Thierry Lefèvre7, David Messika-Zeitoun1,8, Patrice Guerin6, Bertrand Cormier7, Eric Brochet1, Hélène Thibault9, Dominique Himbert1, Sophie Thivolet9, Guillaume Leurent10, Guillaume Bonnet11, Erwan Donal10, Nicolas Piriou6, Christophe Piot12, Gilbert Habib11, Frédéric Rouleau13, Didier Carrié14, Mohammed Nejjari15, Patrick Ohlmann16, Christophe Saint Etienne17, Lionel Leroux18, Martine Gilard19, Géraldine Samson5, Gilles Rioufol20, Delphine Maucort-Boulch4, Jean François Obadia21. 1. Université de Paris and INSERM 1148, Paris, France. 2. APHP, Hôpital Bichat, DHU FIRE, Paris, France. 3. Pharmacy Department and Laboratoire MATEIS, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. 4. Lyon, France; Université Lyon 1, Villeurbanne, France; CNRS, UMR5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Villeurbanne, France. 5. Hopital Cardiovasculaire Louis Pradel, Clinical Investigation Center & Heart Failure Department, INSERM 1407, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. 6. CHU Nantes, INSERM, Nantes Université, Clinique Cardiologique et des Maladies Vasculaires, CIC 1413, Institut du Thorax, Nantes, France. 7. Institut Jacques Cartier, Massy, France. 8. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada. 9. Hôpital Cardiovasculaire Louis Pradel, Service des Explorations Fonctionnelles Cardiovasculaires, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. 10. CHU Rennes, Hôpital Pontchaillou, Rennes, France. 11. APHM, Hôpital de la Timone, Marseille, France. 12. Clinique du Millénaire, Montpellier, France. 13. CHU Angers, Angers, France. 14. CHU Toulouse, Hôpital Rangueil, Toulouse, France. 15. Centre Cardiologique du Nord, Saint-Denis, France. 16. Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France. 17. CHRU de Tours, Hôpital Trousseau, Tours, France. 18. CHU Bordeaux, Hôpital Haut-Lévêque, Pessac, France. 19. CHRU Brest, Hôpital de La Cavale Blanche, Brest, France. 20. Hopital Cardiovasculaire Louis Pradel, Service d'Hémodynamique et Cardiologie Interventionnelle, Hospices Civils de Lyon and Claude Bernard University, Lyon, France. 21. Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.
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 undergopercutaneous 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.
RCT Entities:
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 failurepatients 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.
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