Erwan Donal, Julien Dreyfus, Guillaume Leurent, Augustin Coisne, Pierre-Yves Leroux, Anne Ganivet, Catherine Sportouch, Yoan Lavie-Badie, Patrice Guerin, Frédéric Rouleau, Christelle Diakov, Jan van der Heyden, Stéphane Lafitte, Jean-François Obadia, Mohammed Nejjari, Nicole Karam, Anne Bernard, Antoinette Neylon, Romain Pierrard, Didier Tchetche, Said Ghostine, Gregory Ducrocq, Thiziri Si Moussi, Antoine Jeu, Marcel Peltier, Bernard Cosyns, Yvan Le Dolley, Gilbert Habib, Vincent Auffret, Florent Le Ven, François Picard, Nicolas Piriou, Thierry Laperche, Elena Galli, Sabina Istratoaie, Jerome Jouan, Guillaume Bonnet, Pascal de Groote, Amedeo Anselmi, Jean-Noel Trochu, Emmanuel Oger
{"title":"Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.","authors":"Erwan Donal, Julien Dreyfus, Guillaume Leurent, Augustin Coisne, Pierre-Yves Leroux, Anne Ganivet, Catherine Sportouch, Yoan Lavie-Badie, Patrice Guerin, Frédéric Rouleau, Christelle Diakov, Jan van der Heyden, Stéphane Lafitte, Jean-François Obadia, Mohammed Nejjari, Nicole Karam, Anne Bernard, Antoinette Neylon, Romain Pierrard, Didier Tchetche, Said Ghostine, Gregory Ducrocq, Thiziri Si Moussi, Antoine Jeu, Marcel Peltier, Bernard Cosyns, Yvan Le Dolley, Gilbert Habib, Vincent Auffret, Florent Le Ven, François Picard, Nicolas Piriou, Thierry Laperche, Elena Galli, Sabina Istratoaie, Jerome Jouan, Guillaume Bonnet, Pascal de Groote, Amedeo Anselmi, Jean-Noel Trochu, Emmanuel Oger","doi":"10.1001/jama.2024.21189","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>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.</p><p><strong>Objective: </strong>To evaluate the efficacy of T-TEER + OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation.</p><p><strong>Design, setting, and participants: </strong>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).</p><p><strong>Intervention: </strong>Patients were randomized to T-TEER + OMT or OMT alone.</p><p><strong>Main outcomes and measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions and relevance: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04646811.</p>","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"124-132"},"PeriodicalIF":63.1000,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11733701/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Jama-Journal of the American Medical Association","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jama.2024.21189","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
JAMA (Journal of the American Medical Association) is an international peer-reviewed general medical journal. It has been published continuously since 1883. JAMA is a member of the JAMA Network, which is a consortium of peer-reviewed general medical and specialty publications.
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