Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial - Archive ouverte HAL
Article Dans Une Revue Journal of the American Medical Association Année : 2024

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

1 Centre Hospitalier Universitaire [Rennes]
2 LTSI - Laboratoire Traitement du Signal et de l'Image
3 CCN - Centre cardiologique du Nord
4 Université de Lille
5 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
6 Clinique Médipôle Garonne
7 Clinique du Millénaire - Oc Santé [Montpellier]
8 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
9 Institut du Thorax [Nantes]
10 CHU Angers - Centre Hospitalier Universitaire d'Angers
11 IMM - Institut Mutualiste de Montsouris
12 AZ Jan Palfijn Hospital [Ghent, Belgium]
13 CHU Bordeaux - Centre Hospitalier Universitaire de Bordeaux
14 Hôpital Louis Pradel [CHU - HCL]
15 HEGP - Hôpital Européen Georges Pompidou [APHP]
16 UT - Université de Tours
17 ISCHEMIA - Membrane Signalling and Inflammation in reperfusion Injuries
18 ICPS - Institut Cardiovasculaire Paris Sud
19 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
20 Clinique Pasteur [Toulouse]
21 Hôpital Marie-Lannelongue
22 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
23 CHU La Réunion - Centre Hospitalier Universitaire de La Réunion
24 Hôpital Privé Le Bois Ramsay Santé [Lille]
25 CHU Amiens-Picardie
26 UZ Brussel - Universitair Ziekenhuis Brussel = University Hospital of Brussels
27 Hôpital Saint-Joseph [Marseille]
28 TIMONE - Hôpital de la Timone [CHU - APHM]
29 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
30 UB - Université de Bordeaux
31 CHU Limoges
32 Hôpital Haut-Lévêque [CHU Bordeaux]
33 Institut Pasteur de Lille
34 ERL 9002 - INSERM U1167 - BSI - Biologie Structurale Intégrative
Julien Dreyfus
Patrice Guérin
Christelle Diakov
Jean-François Obadia
Mohammed Nejjari
Nicole Karam
Antoinette Neylon
Didier Tchétché
Said Ghostine
Marcel Peltier
  • Fonction : Auteur
  • PersonId : 1151464
  • IdRef : 119564130
Gilbert Habib
Nicolas Piriou
Jerome Jouan
Guillaume Bonnet
Jean-Noël Trochu

Résumé

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.
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Dates et versions

hal-04833638 , version 1 (12-12-2024)

Identifiants

Citer

Erwan Donal, Julien Dreyfus, Guillaume Leurent, Augustin Coisne, Pierre-Yves Leroux, et al.. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. Journal of the American Medical Association, 2024, ⟨10.1001/jama.2024.21189⟩. ⟨hal-04833638⟩
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