Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation
Key result
T-TEER plus OMT increases the likelihood of 1-year composite clinical improvement by ~83% vs OMT alone.
- n=300
Why the study?
Correction of tricuspid regurgitation using T-TEER in addition to guideline-directed optimized medical therapy may improve clinical outcomes in patients with severe, symptomatic tricuspid regurgitation.
Does tricuspid transcatheter edge-to-edge repair (T-TEER) added to optimized medical therapy improve a composite clinical endpoint in adult patients with severe, symptomatic tricuspid regurgitation?
Key Points
- To evaluate the efficacy of transcatheter edge-to-edge repair combined with optimized medical therapy versus medical therapy alone in patients with severe tricuspid regurgitation.
- Prospective, randomized trial comparing T-TEER plus optimized medical therapy against optimized medical therapy alone.
- Conducted at 24 centers across France and Belgium from March 2021 to March 2023.
- Total of 300 enrolled patients with severe symptomatic tricuspid regurgitation.
- 74.1% of patients in the T-TEER + OMT group improved their composite score at one year compared to 40.6% in the OMT-alone group (P < .001).
- 6.8% of the T-TEER + OMT group experienced massive or torrential tricuspid regurgitation versus 53.5% in the OMT-alone group (P < .001).
- Mean KCCQ summary score was 69.9 in the T-TEER + OMT group and 55.4 in the OMT-alone group (P < .001).
Study Design
Type
RCT (n=300)
Randomization
1:1
Multicenter
Yes
Structured PICO
Does tricuspid transcatheter edge-to-edge repair (T-TEER) added to optimized medical therapy improve a composite clinical endpoint in adult patients with severe, symptomatic tricuspid regurgitation?
P
Population
300 adults with severe, symptomatic tricuspid regurgitation (mean age 78 years, 64% women) randomized to T-TEER plus medical therapy or medical therapy alone and followed for 1 year.
I
Intervention
Tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT)
C
Comparator
Guideline-directed optimized medical therapy (OMT) alone
O
Outcome
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 eventscomposite
Main Result
Absolute Event Rate: 74.1% vs 40.6%
In patients with severe, symptomatic tricuspid regurgitation, adding T-TEER to optimized medical therapy significantly improved a 1-year composite clinical endpoint driven by patient-reported outcomes and reduced TR severity.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“We can observe that at one year follow up, 74% of the patients treated with transcatheter edge-to-edge repair improved, as opposed to 40% in the guideline directed medical therapy group. This is highly significant. If we look in detail at all the components of the primary endpoint, and if we look at all the secondary endpoints, we observe that all the parameters are in favour of the treatment by TEER.”
“Transcatheter edge-to-edge repair is something that probably we have to consider in patients with severe tricuspid regurg, but on top of optimized medical treatment. We still have to optimize medical treatment because when we compare the result that we got and the result from previous studies and registries, it's so impressive to see that the death rate and the rate of hospitalization is much lower in this trial than before. So on top of the medical treatment, T-TEER seems to be efficient and improve dramatically the quality of life and the risk for the patients.”
“Tri.Fr adds to the amount of evidence that suggests that one can palliate TR with edge-to-edge repairs and improve quality of life and the ability to do activities of daily living. So in older patients who are symptom-limited by severe TR, this is an option that [can improve] not their lifespan necessarily, but the quality of their remaining years.”
Implication
T-TEER may reduce HF hospitalizations in severe TR; leaves open whether randomized trials confirm benefit.
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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Cite This Study
Donal et al. (2024) conducted an RCT in Severe, symptomatic tricuspid regurgitation (n=300). Tricuspid transcatheter edge-to-edge repair (T-TEER) + optimized medical therapy (OMT) vs. OMT alone was evaluated on 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. T-TEER plus optimized medical therapy improved the 1-year composite clinical score in 74.1% of patients with severe tricuspid regurgitation compared to 40.6% with medical therapy alone.