Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.
Aged
Cardiac Catheterization
/ methods
Echocardiography, Transesophageal
Female
Follow-Up Studies
Heart Failure
/ etiology
Heart Valve Prosthesis Implantation
/ methods
Humans
Male
Middle Aged
Mitral Valve
/ surgery
Mitral Valve Insufficiency
/ complications
Retrospective Studies
Stroke Volume
/ physiology
Time Factors
Treatment Outcome
Ventricular Function, Left
Heart failure
Percutaneous mitral valve repair
Secondary mitral regurgitation
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
19
08
2019
accepted:
21
08
2019
pubmed:
3
9
2019
medline:
29
10
2020
entrez:
3
9
2019
Statut:
ppublish
Résumé
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. At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm 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.
Banques de données
ClinicalTrials.gov
['NCT01920698']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1619-1627Subventions
Organisme : French Ministry of Health and Research National Program
Pays : International
Investigateurs
Jean-François Obadia
(JF)
Martine Barthelet
(M)
Daniel Grinberg
(D)
Gilles Rioufol
(G)
Hélène Thibault
(H)
Sophie Thivolet
(S)
Alain Furber
(A)
Thomas Benard
(T)
Jean-Louis Debrux
(JL)
Frédéric Pinaud
(F)
Frédéric Rouleau
(F)
Sidney Chocron
(S)
Romain Chopard
(R)
Nicolas Meneveau
(N)
François Schiele
(F)
Martine Gilard
(M)
Jacques Boschat
(J)
Philippe Castellant
(P)
Yannick Jobic
(Y)
Florent Le Ven
(F)
Didier Romain
(D)
Farzin Beygui
(F)
Rémi Sabatier
(R)
Eric Saloux
(E)
Pascal Motreff
(P)
Guillaume Clerfond
(G)
Kasra Azarnoush
(K)
Jean René Lusson
(JR)
Charles Vorilhon
(C)
Emmanuel Teiger
(E)
Clémence Antoine
(C)
Stéphane Champagne
(S)
Jean-Paul Couetil
(JP)
Thibault Damy
(T)
Jean-Luc Dubois-Rande
(JL)
Laura Ernande
(L)
Soulef Guendouz
(S)
Pascal Lim
(P)
Jean-Luc Monin
(JL)
Annabelle Nguyen
(A)
Elisabeth Riant
(E)
Julien Ternacle
(J)
Céline Zerbib
(C)
Bernard Bertrand
(B)
Hélène Bouvaist
(H)
Carole Saunier
(C)
Claude Vaislic
(C)
Riadh Cheikh Khelifa
(RC)
Xavier Favereau
(X)
Loïc Hilpert
(L)
Philippe Maribas
(P)
Alexandre Azmoun
(A)
Jean-Yves Angel
(JY)
Alban Baruteau
(A)
Philippe Brenot
(P)
Philippe Deleuze
(P)
Philippe Garcon
(P)
François Raoux
(F)
Michel Slama
(M)
Eric Van Belle
(E)
Alain Prat
(A)
Augustin Coisne
(A)
Anju Duvapentiah
(A)
Francis Juthier
(F)
Thomas Modine
(T)
Anne-Sophie Polge
(AS)
Marjorie Richardson
(M)
Natacha Rousse
(N)
Hugues Spillemaeker
(H)
Arnaud Sudre
(A)
Flavien Vincent
(F)
André Vincentelli
(A)
Antoine Jeu
(A)
Régis Ketelers
(R)
Jean-Louis Bonnet
(JL)
Guillaume Bonnet
(G)
Gilbert Habib
(G)
Nicolas Michel
(N)
Mathieu Pankert
(M)
Erwan Salaun
(E)
Frédéric Collart
(F)
Rémi Houël
(R)
Jacques Bille
(J)
Philippe Commeau
(P)
Patrick Joly
(P)
Nicolas Michel
(N)
Emmanuel Philip
(E)
Frédéric Collet
(F)
Sébastien Arméro
(S)
Gilles Bayet
(G)
Marie-Paule Giacomoni
(MP)
Alexandre Maximovitch
(A)
Thierry Lefèvre
(T)
Bertrand Cormier
(B)
Mauro Romano
(M)
Florence Leclercq
(F)
Bernard Albat
(B)
Stéphane Cade
(S)
Frédéric Cransac
(F)
Jean-Christophe Macia
(JC)
Christophe Piot
(C)
Fabrice Francois
(F)
Maxime Pons
(M)
Franck Raczka
(F)
Catherine Sportouch
(C)
Yves Juillière
(Y)
Thierry Folliguet
(T)
Olivier Huttin
(O)
Batric Popovic
(B)
Christine Selton-Suty
(C)
Clément Venner
(C)
Patrice Guérin
(P)
Olivier Baron
(O)
Vincent Letocart
(V)
Thierry Letourneau
(T)
Nicolas Piriou
(N)
Jean-Noël Trochu
(JN)
Olivier Belliard
(O)
Philippe Allouch
(P)
Christophe Bensouda
(C)
Sandra Janower
(S)
Serge Makowski
(S)
Damien Pasquier
(D)
Rémy Pillière
(R)
Julien Rosencher
(J)
Pamela Moceri
(P)
Alex Vahanian
(A)
Eric Brochet
(E)
Dominique Himbert
(D)
Bernard Iung
(B)
Patrick Nataf
(P)
Christian Spaulding
(C)
Paul Achouh
(P)
Alain Berrebi
(A)
Jérôme Jouan
(J)
Nicole Karam
(N)
Mariana Mirabel
(M)
Tania Puscas
(T)
Elisabeth Riant
(E)
Po Wen Suen
(PW)
Christophe Caussin
(C)
Alain Berrebi
(A)
Christelle Diakov
(C)
François Philippe
(F)
Aurélie Veugeois
(A)
Jean Philippe Collet
(JP)
Rémi Choussat
(R)
Richard Isnard
(R)
Gilles Montalescot
(G)
Lionel Leroux
(L)
Pierre Coste
(P)
Marina Dijos
(M)
Louis Labrousse
(L)
Stéphane Lafitte
(S)
François Picard
(F)
Pascale Raud-Raynier
(P)
Bruno Degrand
(B)
Marc Bedossa
(M)
Hervé Corbineau
(H)
Erwan Donal
(E)
Guillaume Leurent
(G)
Hélène Eltchaninoff
(H)
Fabrice Bauer
(F)
Christophe Tron
(C)
Mohammed Nejjari
(M)
Davis Attias
(D)
Antoine Gerbay
(A)
Romain Pierrard
(R)
Jean-François Fuzellier
(JF)
Laurent Drogoul
(L)
Jean-Pierre Elebeze
(JP)
Stéphane Lopez
(S)
Claude Mariottini
(C)
Pierre Meyer
(P)
Alain Mihoubi
(A)
Michel Tapia
(M)
Jacques Teboul
(J)
Patrick Ohlmann
(P)
Paola Goette-Dimarco
(P)
Jean-Georges Kretz
(JG)
Arnaud Mommerot
(A)
Olivier Morel
(O)
Hélène Petit-Eisenmann
(H)
Annie Samet
(A)
Annie Trinh
(A)
Didier Carrié
(D)
Mathieu Gautier
(M)
Yoan Lavie Badie
(YL)
Thibault Lhermusier
(T)
Bernard Marcheix
(B)
Didier Tchétché
(D)
Issam Abouliatim
(I)
Laurent Bonfils
(L)
Nicolas Dumonteil
(N)
Bruno Farah
(B)
Olivier Fondard
(O)
Atul Pathak
(A)
Christophe Saint Etienne
(CS)
Anne Bernard
(A)
Fany Dion
(F)
Claudia Loardi
(C)
Laurent Quilliet
(L)
Aurélien Seemann
(A)
Clémence Antoine
(C)
Marc Antoine Arnoult
(MA)
Yvon Meurisse
(Y)
Fabrice Wautot
(F)
Didier Champagnac
(D)
Julie Dementhon
(J)
Vincent Doisy
(V)
Jean-Philippe Frieh
(JP)
Olivier Garrier
(O)
Fadi Jamal
(F)
Stéphanie Lamartine
(S)
Pierre-Yves Leroux
(PY)
Yves Lienhart
(Y)
Patrick Staat
(P)
Oualid Zouaghi
(O)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2019 The Authors. European Journal of Heart Failure © 2019 European Society of Cardiology.
Références
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2016;18:891-975.
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Colvin MM, Drazner MH, Filippatos G, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2016 ACC/AHA/HFSA Focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA Guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation 2016;134:e282-e293.
Goliasch G, Bartko PE, Pavo N, Neuhold S, Wurm R, Mascherbauer J, Lang IM, Strunk G, Hülsmann M. Refining the prognostic impact of functional mitral regurgitation in chronic heart failure. Eur Heart J 2018;39:39-46.
De Bonis M, Al-Attar N, Antunes M, Borger M, Casselman F, Falk V, Folliguet T, Iung B, Lancellotti P, Lentini S, Maisano F, Messika-Zeitoun D, Muneretto C, Pibarot P, Pierard L, Punjabi P, Rosenhek R, Suwalski P, Vahanian A, Wendler O, Prendergast B. Surgical and interventional management of mitral valve regurgitation: a position statement from the European Society of Cardiology Working Groups on Cardiovascular Surgery and Valvular Heart Disease. Eur Heart J 2016;37:133-139.
Michler RE, Smith PK, Parides MK, Ailawadi G, Thourani V, Moskowitz AJ, Acker MA, Hung JW, Chang HL, Perrault LP, Gillinov AM, Argenziano M, Bagiella E, Overbey JR, Moquete EG, Gupta LN, Miller MA, Taddei-Peters WC, Jeffries N, Weisel RD, Rose EA, Gammie JS, DeRose JJ, Puskas JD, Dagenais F, Burks SG, El-Hamamsy I, Milano CA, Atluri P, Voisine P, O'Gara PT, Gelijns AC; CTSN. Two-year outcomes of surgical treatment of moderate ischemic mitral regurgitation. N Engl J Med 2016;374:1932-1941.
Maisano F, Franzen O, Baldus S, Schäfer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol 2013;62:1052-1061.
Nickenig G, Estevez-Loureiro R, Franzen O, Tamburino C, Vanderheyden M, Lüscher TF, Moat N, Price S, Dall'Ara G, Winter R, Corti R, Grasso C, Snow TM, Jeger R, Blankenberg S, Settergren M, Tiroch K, Balzer J, Petronio AS, Büttner HJ, Ettori F, Sievert H, Fiorino MG, Claeys M, Ussia GP, Baumgartner H, Scandura S, Alamgir F, Keshavarzi F, Colombo A, Maisano F, Ebelt H, Aruta P, Lubos E, Plicht B, Schueler R, Pighi M, Di Mario C; Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology. Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. J Am Coll Cardiol 2014;64:875-884.
Chiarito M, Pagnesi M, Martino EA, Pighi M, Scotti A, Biondi-Zoccai G, Latib A, Landoni G, Mario CD, Margonato A, Maisano F, Feldman T, Alfieri O, Colombo A, Godino C. Outcome after percutaneous edge-to-edge mitral repair for functional and degenerative mitral regurgitation: a systematic review and meta-analysis. Heart 2018;104:306-312.
Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefèvre T, Piot C, Rouleau F, Carrié D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous repair or medical treatment for secondary mitral regurgitation. N Engl J Med 2018;379:2297-2306.
Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med 2018;379:2307-2318.
Grayburn PA, Sannino A, Packer M. Proportionate and disproportionate functional mitral regurgitation: a new conceptual framework that reconciles the results of the MITRA-FR and COAPT trials. JACC Cardiovasc Imaging 2019;12:353-362.
Enriquez-Sarano M, Michelena HI, Grigioni F. Treatment of functional mitral regurgitation. Circulation 2019;139:2289-2291.
Praz F, Grasso C, Taramasso M, Baumbach A, Piazza N, Tamburino C, Windecker S, Maisano F, Prendergast B. Mitral regurgitation in heart failure: time for a rethink. Eur Heart J 2019;40:2189-2193.
Nishimura RA, Bonow RO. Percutaneous repair of secondary mitral regurgitation - a tale of two trials. N Engl J Med 2018;379:2374-2376.
Obadia JF, Armoiry X, Iung B, Lefèvre T, Mewton N, Messika-Zeitoun D, Cormier B, Berthiller J, Maucort-Boulch D, Boutitie F, Vaz B, Trochu JN, Vahanian A. The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation. EuroIntervention 2015;10:1354-1360.
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Barón-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schäfers H-J, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012;33:2451-2496.
Lancellotti P, Moura L, Pierard LA, Agricola E, Popescu BA, Tribouilloy C, Hagendorff A, Monin JL, Badano L, Zamorano JL; European Association of Echocardiography. European Association of Echocardiography recommendations for the assessment of valvular regurgitation. Part 2: mitral and tricuspid regurgitation (native valve disease). Eur J Echocardiogr 2010;11:307-332.
McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, GY Lip, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the diagnosis and treatment of acute and chronic heart failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J 2012;33:1787-1847.
Cox DR, Oakes D. Analysis of Survival Data. London: Chapman and Hall; 1984.
Belot A, Rondeau V, Remontet L, Giorgi R; CENSUR Working Survival Group. A joint frailty model to estimate the recurrence process and the disease-specific mortality process without needing the cause of death. Stat Med 2014;33:3147-3166.
Stone GW, Adams DH, Abraham WT, Kappetein AP, Généreux P, Vranckx P, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 2: endpoint definitions: a consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol 2015;66:308-321.
Pocock SJ, Collier TJ. Statistical appraisal of 6 recent clinical trials in cardiology: JACC state-of-the-art review. J Am Coll Cardiol 2019;73:2740-2755.
Greene SJ, Fonarow GC, DeVore AD, Sharma PP, Vaduganathan M, Albert NM, Duffy CI, Hill CL, McCague K, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Butler J. Titration of medical therapy for heart failure with reduced ejection fraction. J Am Coll Cardiol 2019;73:2365-2383.
Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2017;30:303-371.
Lancellotti P, Tribouilloy C, Hagendorff A, Popescu BA, Edvardsen T, Pierard LA, Badano L, Zamorano JL; Scientific Document Committee of the European Association of Cardiovascular Imaging. Recommendations for the echocardiographic assessment of native valvular regurgitation: an executive summary from the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 2013;14:611-644.
Bartko PE, Arfsten H, Heitzinger G, Pavo N, Toma A, Strunk G, Hengstenberg C, Hülsmann M, Goliasch G. A unifying concept for the quantitative assessment of secondary mitral regurgitation. J Am Coll Cardiol 2019;73:2506-2517.
Gaasch WH, Meyer TE. Secondary mitral regurgitation (part 1): volumetric quantification and analysis. Heart 2018;104:634-638.
Gaasch WH, Meyer TE. Secondary mitral regurgitation (part 2): deliberations on mitral surgery and transcatheter repair. Heart 2018;104:639-643.