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

Bernard Iung, Xavier Armoiry, Alec Vahanian, Florent Boutitie, Nathan Mewton, Jean-Noël Trochu, Thierry Lefèvre, David Messika-Zeitoun, Patrice Guerin, Bertrand Cormier, Eric Brochet, Hélène Thibault, Dominique Himbert, Sophie Thivolet, Guillaume Leurent, Guillaume Bonnet, Erwan Donal, Nicolas Piriou, Christophe Piot, Gilbert Habib, Frédéric Rouleau, Didier Carrié, Mohammed Nejjari, Patrick Ohlmann, Christophe Saint Etienne, Lionel Leroux, Martine Gilard, Géraldine Samson, Gilles Rioufol, Delphine Maucort-Boulch, Jean François Obadia, MITRA-FR Investigators, Jean-François Obadia, Martine Barthelet, Daniel Grinberg, Gilles Rioufol, Hélène Thibault, Sophie Thivolet, Alain Furber, Thomas Benard, Jean-Louis Debrux, Frédéric Pinaud, Frédéric Rouleau, Sidney Chocron, Romain Chopard, Nicolas Meneveau, François Schiele, Martine Gilard, Jacques Boschat, Philippe Castellant, Yannick Jobic, Florent Le Ven, Didier Romain, Farzin Beygui, Rémi Sabatier, Eric Saloux, Pascal Motreff, Guillaume Clerfond, Kasra Azarnoush, Jean René Lusson, Charles Vorilhon, Emmanuel Teiger, Clémence Antoine, Stéphane Champagne, Jean-Paul Couetil, Thibault Damy, Jean-Luc Dubois-Rande, Laura Ernande, Soulef Guendouz, Pascal Lim, Jean-Luc Monin, Annabelle Nguyen, Elisabeth Riant, Julien Ternacle, Céline Zerbib, Bernard Bertrand, Hélène Bouvaist, Carole Saunier, Claude Vaislic, Riadh Cheikh Khelifa, Xavier Favereau, Loïc Hilpert, Philippe Maribas, Alexandre Azmoun, Jean-Yves Angel, Alban Baruteau, Philippe Brenot, Philippe Deleuze, Philippe Garcon, François Raoux, Michel Slama, Eric Van Belle, Alain Prat, Augustin Coisne, Anju Duvapentiah, Francis Juthier, Thomas Modine, Anne-Sophie Polge, Marjorie Richardson, Natacha Rousse, Hugues Spillemaeker, Arnaud Sudre, Flavien Vincent, André Vincentelli, Antoine Jeu, Régis Ketelers, Jean-Louis Bonnet, Guillaume Bonnet, Gilbert Habib, Nicolas Michel, Mathieu Pankert, Erwan Salaun, Frédéric Collart, Rémi Houël, Jacques Bille, Philippe Commeau, Patrick Joly, Nicolas Michel, Emmanuel Philip, Frédéric Collet, Sébastien Arméro, Gilles Bayet, Marie-Paule Giacomoni, Alexandre Maximovitch, Thierry Lefèvre, Bertrand Cormier, Mauro Romano, Florence Leclercq, Bernard Albat, Stéphane Cade, Frédéric Cransac, Jean-Christophe Macia, Christophe Piot, Fabrice Francois, Maxime Pons, Franck Raczka, Catherine Sportouch, Yves Juillière, Thierry Folliguet, Olivier Huttin, Batric Popovic, Christine Selton-Suty, Clément Venner, Patrice Guérin, Olivier Baron, Vincent Letocart, Thierry Letourneau, Nicolas Piriou, Jean-Noël Trochu, Olivier Belliard, Philippe Allouch, Christophe Bensouda, Sandra Janower, Serge Makowski, Damien Pasquier, Rémy Pillière, Julien Rosencher, Pamela Moceri, Alex Vahanian, Eric Brochet, Dominique Himbert, Bernard Iung, Patrick Nataf, Christian Spaulding, Paul Achouh, Alain Berrebi, Jérôme Jouan, Nicole Karam, Mariana Mirabel, Tania Puscas, Elisabeth Riant, Po Wen Suen, Christophe Caussin, Alain Berrebi, Christelle Diakov, François Philippe, Aurélie Veugeois, Jean Philippe Collet, Rémi Choussat, Richard Isnard, Gilles Montalescot, Lionel Leroux, Pierre Coste, Marina Dijos, Louis Labrousse, Stéphane Lafitte, François Picard, Pascale Raud-Raynier, Bruno Degrand, Marc Bedossa, Hervé Corbineau, Erwan Donal, Guillaume Leurent, Hélène Eltchaninoff, Fabrice Bauer, Christophe Tron, Mohammed Nejjari, Davis Attias, Antoine Gerbay, Romain Pierrard, Jean-François Fuzellier, Laurent Drogoul, Jean-Pierre Elebeze, Stéphane Lopez, Claude Mariottini, Pierre Meyer, Alain Mihoubi, Michel Tapia, Jacques Teboul, Patrick Ohlmann, Paola Goette-Dimarco, Jean-Georges Kretz, Arnaud Mommerot, Olivier Morel, Hélène Petit-Eisenmann, Annie Samet, Annie Trinh, Didier Carrié, Mathieu Gautier, Yoan Lavie Badie, Thibault Lhermusier, Bernard Marcheix, Didier Tchétché, Issam Abouliatim, Laurent Bonfils, Nicolas Dumonteil, Bruno Farah, Olivier Fondard, Atul Pathak, Christophe Saint Etienne, Anne Bernard, Fany Dion, Claudia Loardi, Laurent Quilliet, Aurélien Seemann, Clémence Antoine, Marc Antoine Arnoult, Yvon Meurisse, Fabrice Wautot, Didier Champagnac, Julie Dementhon, Vincent Doisy, Jean-Philippe Frieh, Olivier Garrier, Fadi Jamal, Stéphanie Lamartine, Pierre-Yves Leroux, Yves Lienhart, Patrick Staat, Oualid Zouaghi, Bernard Iung, Xavier Armoiry, Alec Vahanian, Florent Boutitie, Nathan Mewton, Jean-Noël Trochu, Thierry Lefèvre, David Messika-Zeitoun, Patrice Guerin, Bertrand Cormier, Eric Brochet, Hélène Thibault, Dominique Himbert, Sophie Thivolet, Guillaume Leurent, Guillaume Bonnet, Erwan Donal, Nicolas Piriou, Christophe Piot, Gilbert Habib, Frédéric Rouleau, Didier Carrié, Mohammed Nejjari, Patrick Ohlmann, Christophe Saint Etienne, Lionel Leroux, Martine Gilard, Géraldine Samson, Gilles Rioufol, Delphine Maucort-Boulch, Jean François Obadia, MITRA-FR Investigators, Jean-François Obadia, Martine Barthelet, Daniel Grinberg, Gilles Rioufol, Hélène Thibault, Sophie Thivolet, Alain Furber, Thomas Benard, Jean-Louis Debrux, Frédéric Pinaud, Frédéric Rouleau, Sidney Chocron, Romain Chopard, Nicolas Meneveau, François Schiele, Martine Gilard, Jacques Boschat, Philippe Castellant, Yannick Jobic, Florent Le Ven, Didier Romain, Farzin Beygui, Rémi Sabatier, Eric Saloux, Pascal Motreff, Guillaume Clerfond, Kasra Azarnoush, Jean René Lusson, Charles Vorilhon, Emmanuel Teiger, Clémence Antoine, Stéphane Champagne, Jean-Paul Couetil, Thibault Damy, Jean-Luc Dubois-Rande, Laura Ernande, Soulef Guendouz, Pascal Lim, Jean-Luc Monin, Annabelle Nguyen, Elisabeth Riant, Julien Ternacle, Céline Zerbib, Bernard Bertrand, Hélène Bouvaist, Carole Saunier, Claude Vaislic, Riadh Cheikh Khelifa, Xavier Favereau, Loïc Hilpert, Philippe Maribas, Alexandre Azmoun, Jean-Yves Angel, Alban Baruteau, Philippe Brenot, Philippe Deleuze, Philippe Garcon, François Raoux, Michel Slama, Eric Van Belle, Alain Prat, Augustin Coisne, Anju Duvapentiah, Francis Juthier, Thomas Modine, Anne-Sophie Polge, Marjorie Richardson, Natacha Rousse, Hugues Spillemaeker, Arnaud Sudre, Flavien Vincent, André Vincentelli, Antoine Jeu, Régis Ketelers, Jean-Louis Bonnet, Guillaume Bonnet, Gilbert Habib, Nicolas Michel, Mathieu Pankert, Erwan Salaun, Frédéric Collart, Rémi Houël, Jacques Bille, Philippe Commeau, Patrick Joly, Nicolas Michel, Emmanuel Philip, Frédéric Collet, Sébastien Arméro, Gilles Bayet, Marie-Paule Giacomoni, Alexandre Maximovitch, Thierry Lefèvre, Bertrand Cormier, Mauro Romano, Florence Leclercq, Bernard Albat, Stéphane Cade, Frédéric Cransac, Jean-Christophe Macia, Christophe Piot, Fabrice Francois, Maxime Pons, Franck Raczka, Catherine Sportouch, Yves Juillière, Thierry Folliguet, Olivier Huttin, Batric Popovic, Christine Selton-Suty, Clément Venner, Patrice Guérin, Olivier Baron, Vincent Letocart, Thierry Letourneau, Nicolas Piriou, Jean-Noël Trochu, Olivier Belliard, Philippe Allouch, Christophe Bensouda, Sandra Janower, Serge Makowski, Damien Pasquier, Rémy Pillière, Julien Rosencher, Pamela Moceri, Alex Vahanian, Eric Brochet, Dominique Himbert, Bernard Iung, Patrick Nataf, Christian Spaulding, Paul Achouh, Alain Berrebi, Jérôme Jouan, Nicole Karam, Mariana Mirabel, Tania Puscas, Elisabeth Riant, Po Wen Suen, Christophe Caussin, Alain Berrebi, Christelle Diakov, François Philippe, Aurélie Veugeois, Jean Philippe Collet, Rémi Choussat, Richard Isnard, Gilles Montalescot, Lionel Leroux, Pierre Coste, Marina Dijos, Louis Labrousse, Stéphane Lafitte, François Picard, Pascale Raud-Raynier, Bruno Degrand, Marc Bedossa, Hervé Corbineau, Erwan Donal, Guillaume Leurent, Hélène Eltchaninoff, Fabrice Bauer, Christophe Tron, Mohammed Nejjari, Davis Attias, Antoine Gerbay, Romain Pierrard, Jean-François Fuzellier, Laurent Drogoul, Jean-Pierre Elebeze, Stéphane Lopez, Claude Mariottini, Pierre Meyer, Alain Mihoubi, Michel Tapia, Jacques Teboul, Patrick Ohlmann, Paola Goette-Dimarco, Jean-Georges Kretz, Arnaud Mommerot, Olivier Morel, Hélène Petit-Eisenmann, Annie Samet, Annie Trinh, Didier Carrié, Mathieu Gautier, Yoan Lavie Badie, Thibault Lhermusier, Bernard Marcheix, Didier Tchétché, Issam Abouliatim, Laurent Bonfils, Nicolas Dumonteil, Bruno Farah, Olivier Fondard, Atul Pathak, Christophe Saint Etienne, Anne Bernard, Fany Dion, Claudia Loardi, Laurent Quilliet, Aurélien Seemann, Clémence Antoine, Marc Antoine Arnoult, Yvon Meurisse, Fabrice Wautot, Didier Champagnac, Julie Dementhon, Vincent Doisy, Jean-Philippe Frieh, Olivier Garrier, Fadi Jamal, Stéphanie Lamartine, Pierre-Yves Leroux, Yves Lienhart, Patrick Staat, Oualid Zouaghi

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.

© 2019 The Authors. European Journal of Heart Failure © 2019 European Society of Cardiology.

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