T-TEER for Severe TR: Full TRILUMINATE Pivotal Cohort Outcomes
Quick Takes
- TRILUMINATE was the first ever RCT evaluating tricuspid transcatheter edge-to-edge repair (T-TEER) for severe TR. Primary cohort results were published in 2023 and showed significant improvement in QOL measures among patients undergoing T-TEER but no difference in mortality or HF hospitalizations at 1 year.
- The current analysis is a report on data from enrollment of additional patients (n = 222) combined with the original cohort. Hierarchical primary endpoint of all-cause mortality or tricuspid valve surgery, HF hospitalizations, and QOL improvement measured by KCCQ at 1 year favored T-TEER (win ratio = 1.84).
- This was driven primarily by KCCQ improvement (>15-point change at 1 year = 49.5% vs. 25.6%) with no significant differences in mortality and tricuspid valve surgery or HF hospitalizations.
Study Questions:
What is the clinical impact of tricuspid regurgitation (TR) reduction with tricuspid transcatheter edge-to-edge repair (T-TEER)?
Methods:
The TRILUMINATE Pivotal trial is an international randomized controlled trial (RCT) of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve (TV) surgery, heart failure hospitalizations (HFH), and quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year.
Results:
Between August 21, 2019 and June 29, 2022, 572 subjects were randomized, including the primary cohort (n = 350) and subsequent enrollment (n = 222). Subjects were elderly (78.1 ± 7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio = 1.84, p < 0.0001). Freedom from all-cause mortality and TV surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (p = 0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs. 0.20 events/patient-year, p = 0.40). A significant treatment effect was observed for change in QOL with 49.5% of device subjects achieving a ≥15-point KCCQ score improvement (compared to 25.6% of control subjects, p < 0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs. 5.3%, p < 0.0001), KCCQ change at 1 year (13.0 ± 1.4 vs. -0.5 ± 1.4 points, p < 0.0001), and 6-minute walk distance change at 1 year (1.7 ± 7.5 vs. -27.4 ± 7.4 meters, p < 0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs. performance goal: 90%, p < 0.0001).
Conclusions:
TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in 6-minute walk distance and health status. Rates of all-cause mortality or TV surgery and HFH through 1 year were not reduced by T-TEER.
Perspective:
TRILUMINATE was the first ever RCT evaluating T-TEER for severe TR. Primary cohort results were published in 2023 and showed significant improvement in QOL measures among patients undergoing T-TEER but no difference in mortality or HFH at 1 year. The current analysis is a report on data from enrollment of additional patients (n = 222) combined with the original cohort. Hierarchical primary endpoint of all-cause mortality or TV surgery, HFH, and QOL improvement measured by KCCQ at 1 year favored T-TEER (win ratio = 1.84). This was driven primarily by KCCQ improvement (>15-point change at 1 year = 49.5% vs. 25.6%) with no significant differences in mortality and TV surgery or HFH. Results are reassuring for safety and efficacy in achieving improvement in degree of TR. Longer-term follow-up will be needed to show definitive impact on clinical outcomes such as HF and mortality.
Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease
Keywords: Heart Failure, Quality of Life, TCT24, Transcatheter Cardiovascular Therapeutics, Tricuspid Valve Insufficiency
< Back to Listings