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

• Published in: JAMA : the journal of the American Medical Association 2024-11
• Main Authors: Donal, Erwan, Dreyfus, Julien, Leurent, Guillaume, Coisne, Augustin, Leroux, Pierre-Yves, Ganivet, Anne, Sportouch, Catherine, Lavie-Badie, Yoan, Guerin, Patrice, Rouleau, Frédéric, Diakov, Christelle, van der Heyden, Jan, Lafitte, Stéphane, Obadia, Jean-François, Nejjari, Mohammed, Karam, Nicole, Bernard, Anne, Neylon, Antoinette, Pierrard, Romain, Tchetche, Didier, Ghostine, Said, Ducrocq, Gregory, Si Moussi, Thiziri, Jeu, Antoine, Peltier, Marcel, Cosyns, Bernard, Le Dolley, Yvan, Habib, Gilbert, Auffret, Vincent, Le Ven, Florent, Picard, François, Piriou, Nicolas, Laperche, Thierry, Galli, Elena, Istratoaie, Sabina, Jouan, Jerome, Bonnet, Guillaume, de Groote, Pascal, Anselmi, Amedeo, Trochu, Jean-Noel, Oger, Emmanuel
• Format: Article
• Language: English
• Subjects: Bioengineering; Life Sciences
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.2024.21189

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