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Randomized Controlled Trial
. 2025 Jan 14;333(2):124-132.
doi: 10.1001/jama.2024.21189.

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

Erwan Donal  1 , Julien Dreyfus  2 , Guillaume Leurent  1 , Augustin Coisne  3 , Pierre-Yves Leroux  4 , Anne Ganivet  5 , Catherine Sportouch  6 , Yoan Lavie-Badie  7 , Patrice Guerin  8 , Frédéric Rouleau  9 , Christelle Diakov  10 , Jan van der Heyden  11 , Stéphane Lafitte  12 , Jean-François Obadia  13 , Mohammed Nejjari  2 , Nicole Karam  14 , Anne Bernard  15 , Antoinette Neylon  16 , Romain Pierrard  17 , Didier Tchetche  18 , Said Ghostine  19 , Gregory Ducrocq  20 , Thiziri Si Moussi  21 , Antoine Jeu  22 , Marcel Peltier  23 , Bernard Cosyns  24 , Yvan Le Dolley  25 , Gilbert Habib  26 , Vincent Auffret  1 , Florent Le Ven  27 , François Picard  12 , Nicolas Piriou  8 , Thierry Laperche  2 , Elena Galli  1 , Sabina Istratoaie  1 , Jerome Jouan  28 , Guillaume Bonnet  12 , Pascal de Groote  29 , Amedeo Anselmi  1 , Jean-Noel Trochu  8 , Emmanuel Oger  30 ; Tri-Fr Investigators
Affiliations
Randomized Controlled Trial

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

Erwan Donal et al. JAMA. .

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.

Trial registration: ClinicalTrials.gov Identifier: NCT04646811.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Donal reported receiving nonfinancial support from GE Healthcare, receiving grants from Abbott Structural Heart, and receiving personal fees from Pfizer and Alnylam. Dr Dreyfus reported receiving personal fees from Abbott. Dr Leurent reported receiving personal fees from Abbott Medical and Edwards Lifesciences. Dr Leroux reported receiving proctoring fees from Abbott. Dr Sportouch reported receiving meeting fees from Abbott. Dr Lavie-Badie reported receiving personal fees from Abbott Vascular, GE HealthCare, and Siemens. Dr Guerin reported receiving grants from Edwards, Abbott, and Medtronic and receiving personal fees from Abbott. Dr Diakov reported receiving personal fees from Abbott Cardiovascular and Philips Healthcare and receiving grants from Medtronic. Dr Obadia reported receiving grants from Abbott and Jenscare Scientific and receiving personal fees from Delacroix Chevalier and Landanger. Dr Nejjari reported receiving personal fees from Abbott Vascular. Dr Karam reported receiving consulting fees from Abbott. Dr Bernard reported receiving personal fees from Abbott, Edwards, Medtronic, Pfizer, Boerhinger Ingelheim, Bristol Myers Squibb, General Electric, and Boston Scientific. Dr Pierrard reported receiving personal fees from Abbott Structural Heart. Dr Ghostine reported receiving proctoring fees from Abbott. Dr Ducrocq reported receiving personal fees from Abbott, Amarin, Amgen, AstraZeneca, Bayer, Boston Scientific, Bristol Myers Squibb, Novo Nordisk, and Sanofi. Dr Auffret reported receiving speaking fees from Edwards and Medtronic and receiving consulting fees from Medtronic. Dr Le Ven reported receiving personal fees from General Electric, Amgen, Bristol Myers Squibb, and Novartis. Dr Picard reported receiving personal fees from Novartis, Novo Nordisk, AstraZeneca, and Boehringer Ingelheim. Dr Piriou reported receiving honoraria from Abbott. Dr de Groote reported receiving personal fees from Novartis, Bayer, AstraZeneca, Bristol Myers Squibb, Vifor Pharma, and Merck Sharpe & Dohme and serving on boards for Janssen, Abbott, Servier, and Boehringer Ingelheim. Dr Anselmi reported receiving personal fees from Abbott Cardiovascular. Dr Trochu reported receiving consulting fees from Abbott, AstraZeneca, Bristol Myers Squibb, Vifor Pharma, Bayer, and Novartis and receiving lecture fees from Boehringer Ingelheim. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, Randomization, and Follow-Up in a Trial of Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation
OMT indicates optimized medical therapy; and T-TEER, tricuspid transcatheter edge-to-edge repair. aThree patients withdrew consent and 1 died. bPatients withdrew consent early or were lost to follow-up.
Figure 2.
Figure 2.. KCCQ Summary Score Over Time and Magnitude of Reduction in Tricuspid Regurgitation
Reduction in tricuspid regurgitation is the delay in the echo grading of the tricuspid regurgitation vs the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. The KCCQ has a score range of 0 to 100; scores of 0 to 24 indicate very poor to poor quality of life; 25 to 49, poor to fair; 50 to 74, fair to good; and 75 to 100, good to very good. Boxes indicate IQR (25th-75th); horizontal lines within boxes, median; whiskers, smallest and largest values within 1.5 times the IQR; dots outside the whiskers, outliers.
Figure 3.
Figure 3.. Change in KCCQ Overall Summary Score Over Time
The Kansas City Cardiomyopathy Questionnaire (KCCQ) has a score range of 0 to 100; scores of 0 to 24 indicate very poor to poor quality of life; 25 to 49, poor to fair; 50 to 74, fair to good; and 75 to 100, good to very good. Boxes indicate IQR (25th-75th); horizontal lines within boxes, median; whiskers, smallest and largest values within 1.5 times the IQR; dots outside the whiskers, outliers. OMT indicates optimized medical therapy; and T-TEER, tricuspid transcatheter edge-to-edge repair.
Figure 4.
Figure 4.. Survival Curves for Patients in the T-TEER + OMT Group and the OMT-Alone Group
OMT indicates optimized medical therapy; and T-TEER, tricuspid transcatheter edge-to-edge repair.
See this image and copyright information in PMC

References

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