Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.

Autor:	Donal E; Université de Rennes, CHU Rennes, Service de Cardiologie Inserm, LTSI-UMR 1099, Rennes, France., Dreyfus J; Centre Cardiologique du Nord, Service de Cardiologie, Saint-Denis, France., Leurent G; Université de Rennes, CHU Rennes, Service de Cardiologie Inserm, LTSI-UMR 1099, Rennes, France., Coisne A; Université de Lille, CHU Lille, Service d'Explorations Fonctionnelles Cardio-vasculaires, Lille, France., Leroux PY; Clinique du Medipôle, Villeurbanne, France., Ganivet A; CHU Rennes, Direction de la Recherche et de l'Innovation, Rennes, France., Sportouch C; Clinique du Millénaire, Montpellier, France., Lavie-Badie Y; Université de Toulouse, CHU Toulouse Hôpital Rangueil, Centre de valves cardiaques, Toulouse France., Guerin P; Université de Nantes, CHU Nantes, CNRS, INSERM, Institut du thorax, Nantes, France., Rouleau F; CHU Angers, Service médico-chirurgical des valvulopathies, Angers, France., Diakov C; Institut mutualiste Montsouris, Service de Cardiologie, Paris, France., van der Heyden J; St-Jan Hospital, Bruges, Belgique., Lafitte S; Université de Bordeaux, CHU Bordeaux Hôpital Haut-Lévêque, Service médico-chirurgical, RHU Envisage, ANR-23-RHUS-0007, Bordeaux France., Obadia JF; Hôpital Louis Pradel, Service de chirurgie cardiothoracique et transplantation, Lyon, France., Nejjari M; Centre Cardiologique du Nord, Service de Cardiologie, Saint-Denis, France., Karam N; Université Paris Cité, Hôpital Européen Georges Pompidou, Service de Cardiologie, Paris, France., Bernard A; Université de Tours, CHU Tours, Service de Cardiologie, Inserm U1327 ISCHEMIA, Tours, France., Neylon A; Institut Cardiovasculaire Paris Sud, Massy, France., Pierrard R; CHU Saint-Etienne, service de Cardiologie, Saint-Etienne, France., Tchetche D; Clinique Pasteur, Toulouse, France., Ghostine S; Hôpital Marie Lannelongue, service de Cardiologie diagnostique et interventionnelle, Le Plessis Robinson, France., Ducrocq G; Département de Cardiologie, Hôpital Bichat Assistance Publique Hôpitaux de Paris, France., Si Moussi T; CHU La Réunion, Saint Denis, France., Jeu A; Ramsay santé, Hôpital Privé Le Bois, Lille, France., Peltier M; CHU Amiens, service de Cardiologie, Amiens, France., Cosyns B; Cardiology department, Center of cardiovascular disease (CHVZ), Universitair Ziekenhuis Brussel,Brussels Belgium., Le Dolley Y; Unité de thérapie valvulaire percutanée, Hôpital Saint Joseph, Marseille, France., Habib G; APHM, Hôpital La Timone, service de Cardiologie, Marseille, France-URMITE, Aix Marseille Université-IHU-Méditerranée Infection., Auffret V; Université de Rennes, CHU Rennes, Service de Cardiologie Inserm, LTSI-UMR 1099, Rennes, France., Le Ven F; CHU Brest, service de Cardiologie, Brest, France., Picard F; Université de Bordeaux, CHU Bordeaux Hôpital Haut-Lévêque, Service médico-chirurgical, RHU Envisage, ANR-23-RHUS-0007, Bordeaux France., Piriou N; Université de Nantes, CHU Nantes, CNRS, INSERM, Institut du thorax, Nantes, France., Laperche T; Centre Cardiologique du Nord, Service de Cardiologie, Saint-Denis, France., Galli E; Université de Rennes, CHU Rennes, Service de Cardiologie Inserm, LTSI-UMR 1099, Rennes, France., Istratoaie S; Université de Rennes, CHU Rennes, Service de Cardiologie Inserm, LTSI-UMR 1099, Rennes, France., Jouan J; CHU Limoges, service de chirurgie Cardio-thoracique, Limoges, France., Bonnet G; Université de Bordeaux, CHU Bordeaux Hôpital Haut-Lévêque, Service médico-chirurgical, RHU Envisage, ANR-23-RHUS-0007, Bordeaux France., de Groote P; CHU Lille, Service de Cardiologie, Inserm U1167, Institut Pasteur de Lille, Lille, France., Anselmi A; Université de Rennes, CHU Rennes, Service de Cardiologie Inserm, LTSI-UMR 1099, Rennes, France., Trochu JN; Université de Nantes, CHU Nantes, CNRS, INSERM, Institut du thorax, Nantes, France., Oger E; Université de Rennes, CHU Rennes, Service de pharmacologie clinique, Rennes, France.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2024 Nov 27. Date of Electronic Publication: 2024 Nov 27.
DOI:	10.1001/jama.2024.21189
Abstrakt:	Importance: Correction of tricuspid regurgitation using tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT) may improve clinical outcomes. Objective: To evaluate the efficacy of T-TEER + OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation. Design, Setting, and Participants: Investigator-initiated, prospective, randomized (1:1) trial evaluating T-TEER + OMT vs OMT alone in adult patients with severe, symptomatic tricuspid regurgitation. The trial was conducted at 24 centers in France and Belgium (March 2021 to March 2023; latest follow-up in April 2024). Intervention: Patients were randomized to T-TEER + OMT or OMT alone. Main Outcomes and Measures: The primary outcome was a composite clinical end point at 1 year comprising change in New York Heart Association class, change in patient global assessment, or occurrence of major cardiovascular events. Tricuspid regurgitation severity was the first of 6 secondary outcomes analyzed in a hierarchical closed-testing procedure, including Kansas City Cardiomyopathy Questionnaire (KCCQ) score, patient global assessment, and a composite outcome of all-cause death, tricuspid valve surgery, KCCQ score improvement, or time to hospitalization for heart failure. Results: Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women), 152 were allocated to T-TEER + OMT and 148 to OMT alone. At 1 year, 109 patients (74.1%) in the T-TEER + OMT group had an improved composite score compared with 58 patients (40.6%) in the OMT-alone group. Massive or torrential tricuspid regurgitation was found in 6.8% of patients in the T-TEER + OMT group and in 53.5% of those in the OMT-alone group (P < .001). Mean overall KCCQ summary score at 1 year was 69.9 (SD, 25.5) for the T-TEER + OMT group and 55.4 (SD, 28.8) for the OMT-alone group (P < .001). The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) (P < .001). Conclusions and Relevance: T-TEER reduces tricuspid regurgitation severity and improves a composite score driven by improved patient-reported outcome measures in patients with severe, symptomatic tricuspid regurgitation. Trial Registration: ClinicalTrials.gov Identifier: NCT04646811.
Databáze:	MEDLINE
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