T-TEER for Severe TR: Full TRILUMINATE Pivotal Cohort Outcomes

Oct 27, 2024
Font Size
A
A
A
Authors:
Tang GH, Hahn RT, Whisenant BK, et al., on behalf of the TRILUMINATE Pivotal Investigators.
Citation:
Tricuspid Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: 1-Year Outcomes From the Full TRILUMINATE Pivotal Randomized Cohort. J Am Coll Cardiol 2024;Oct 27:[Epub ahead of print].
Summary By:
Bina Ahmed, MD, FACC

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