Guillaume Leurent1,2, MD; Vincent Auffret1,2, MD, PhD; Erwan Donal1,2, MD, PhD; Hervé Corbineau3, MD, PhD; Daniel Grinberg4, MD; Guillaume Bonnet5, MD; Pierre-Yves Leroux6, MD; Patrice Guérin7, MD, PhD; Fabrice Wautot8, MD; Thierry Lefèvre9, MD; David Messika-Zeitoun10, MD, PhD; Bernard Iung11, MD; Xavier Armoiry12,13, PhD, PharmD; Jean Noël Trochu7, MD, PhD; Florent Boutitie14, PhD; Jean-Francois Obadia4, MD, PhD
1. Université de Rennes, CHU Rennes, INSERM, LTSI - UMR 1099, Rennes, France; 2. Service de Cardiologie, CHU Rennes, Rennes, France; 3. Division of Thoracic and Cardiovascular Surgery, CHU Rennes, Rennes, France; 4. Hôpital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France; 5. Service de Cardiologie Interventionnelle, CHU Timone, Assistance Publique-Hôpitaux de Marseille, Marseille, France and Aix Marseille Université, INSERM- Marseille, France; 6. Cardiologie Médicale et Structurelle, Médipôle Lyon-Villeurbanne, France; 7. Université Nantes, CHU Nantes, CNRS, INSERM, L'institut du Thorax, Nantes, France; 8. Centre Cardio-Thoracique de Monaco, Monaco; 9. Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Ramsay Santé, Massy, France; 10. Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada; 11. Hôpital Bichat – Claude Bernard, DHU FIRE, Paris, France and Université de Paris and INSERM 1148; Paris, France; 12. Pharmacy Department, University of Lyon, School of Pharmacy (ISPB)/UMR CNRS 5510 MATEIS/Edouard Herriot Hospital, Lyon, France; 13. University of Warwick, Warwick Medical School, Coventry, United Kingdom; 14. Service de Biostatistique - Bioinformatique, Pôle Santé Publique, Hospices Civils de Lyon, Lyon; and Université Lyon 1, Villeurbanne, France; and CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne, France
Background: In the MITRA-FR trial, transcatheter mitral valve repair (TMVR) was not associated with a 2-year clinical benefit in patients with secondary mitral regurgitation (SMR).
Aims: This landmark analysis aimed at investigating a potential reduction of the hospitalisation rate for heart failure (HF) between 12 and 24 months after inclusion in the MITRA-FR trial in patients randomised to the intervention group (TMVR with the MitraClip device), as compared with patients randomised to the control group (guideline-directed medical therapy [GDMT]).
Methods: The MITRA-FR trial randomised 307 patients with SMR for TMVR on top of GDMT (TMVR group; n=152) or for GDMT alone (control group; n=155). We conducted a 12-month landmark analysis in surviving patients who were not hospitalised for HF within the first 12 months of follow-up. The primary endpoint was the 1-year cumulative number of HF hospitalisations.
Results: A total of 140 patients (TMVR group: 67; GDMT group: 73) were selected for this landmark analysis with similar characteristics at inclusion in the trial. The primary endpoint was 28 events per 100 patient-years in the TMVR group, as compared with 60 events per 100 patient-years in the GDMT group (hazard ratio [HR] 0.46, 95% confidence interval [CI]: 0.20-1.02; p=0.057).
Conclusions: In this landmark analysis of the MITRA-FR trial, the cumulative rate of HF hospitalisation between 12 and 24 months among patients treated with TMVR on top of GDMT was approximately half as many as those of patients treated with GDMT alone, a difference which did not reach statistical significance in the setting of a low number of events.
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chronic heart failureclinical trialsmitral valve repair
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