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
Université de Rennes, CHU Rennes, Service de Cardiologie Inserm, LTSI-UMR 1099, Rennes, France.
Centre Cardiologique du Nord, Service de Cardiologie, Saint-Denis, France.
JAMA. 2025 Jan 14;333(2):124-132. doi: 10.1001/jama.2024.21189.
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.
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).
Patients were randomized to T-TEER + OMT or OMT alone.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT04646811.
除指南指导的优化药物治疗（OMT）外，使用经导管三尖瓣缘对缘修复术（T-TEER）纠正三尖瓣反流可能改善临床结局。
评估T-TEER联合OMT与单纯OMT治疗重度症状性三尖瓣反流患者的疗效。
设计、地点和参与者：由研究者发起的前瞻性随机（1:1）试验，评估T-TEER联合OMT与单纯OMT治疗成年重度症状性三尖瓣反流患者的疗效。该试验在法国和比利时的24个中心进行（2021年3月至2023年3月；最新随访于2024年4月）。
患者被随机分为T-TEER联合OMT组或单纯OMT组。
主要结局是1年时的综合临床终点，包括纽约心脏协会心功能分级的变化、患者整体评估的变化或重大心血管事件的发生。三尖瓣反流严重程度是在分层封闭式检验程序中分析的6个次要结局中的第一个，包括堪萨斯城心肌病问卷（KCCQ）评分、患者整体评估以及全因死亡、三尖瓣手术、KCCQ评分改善或因心力衰竭住院时间的综合结局。
在300名入组患者中（平均年龄78[标准差，6]岁，63.7%为女性），152名被分配到T-TEER联合OMT组；148名被分配到单纯OMT组。1年时，T-TEER联合OMT组109例患者（74.1%）综合评分改善，而单纯OMT组为58例患者（40.6%）。T-TEER联合OMT组6.8%的患者存在大量或重度三尖瓣反流，单纯OMT组为53.5%（P<0.001）。T-TEER联合OMT组1年时KCCQ总体平均总结评分为69.9（标准差，25.5），单纯OMT组为55.4（标准差，28.8）（P<0.001）。综合次要结局的获胜比为 = 2.06（95%置信区间，1.38 - 3.08）（P<0.001）。
T-TEER可降低重度症状性三尖瓣反流患者的三尖瓣反流严重程度，并通过改善患者报告的结局指标来提高综合评分。
ClinicalTrials.gov标识符：NCT04646811 。
