TRILUMINATE Study Demonstrates Safety and Improved Quality of Life Associated With Tricuspid TEER for Severe Tricuspid Regurgitation

June 26, 2023—In an article published in The New England Journal of Medicine, Sorajja et al report results of the international, prospective, randomized controlled TRILUMINATE study, demonstrating that percutaneous tricuspid transcatheter edge-to-edge repair (TEER) for severe tricuspid regurgitation (TR) is safe and associated with improved quality of life (QOL) at 1 year.

Patients were enrolled from 65 centers in the United States, Canada, and Europe between August 21, 2019 and September 29, 2021 and randomized to undergo TEER with the TriClip transcatheter tricuspid valve repair system (Abbott) or guideline-directed medical therapy (GDMT) (control).

Eligible patients had severe, symptomatic (New York Heart Association [NYHA] functional class II-IVa) TR, pulmonary artery systolic pressure < 70 mm Hg, were on stable GDMT for heart failure, no other cardiovascular conditions requiring intervention, and were at intermediate or greater surgical risk. Patients underwent TEER within 14 days after randomization. Follow-up occurred at 1, 6, and 12 months, consisting of symptom assessment, 6-minute walk test (6MWT), and QOL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).

The primary endpoint was a hierarchical composite of death from any cause or tricuspid valve surgery, hospitalization for heart failure (HF), and improvement in QOL as defined by the KCCQ (increase of ≥ 15 points at 1 year). Secondary endpoints included freedom from major adverse events within 30 days, changes in KCCQ from baseline to 1 year, reduction in TR severity to moderate or less at 30 days (graded 1-5), and change in 6MWT from baseline to 1 year.

An independent echocardiographic laboratory assessed all echocardiography data, and an independent clinical events committee adjudicated adverse events.

The primary endpoint was analyzed using the Finkelstein-Schoenfeld method and a win ratio. If the results were significant, four powered secondary endpoints were analyzed in prespecified hierarchical order to control for multiple comparisons.

A total of 350 were randomized (175 patients to each group; mean age, 78 ± 7 years); 54.9% were women. Three patients withdrew from the TEER group before the index procedure, and one patient in the control group died, leaving 172 and 174 patients in the TEER and control groups, respectively. The device was successfully implanted in 170 of 172 (98.8%) patients in the TEER group (mean, 2.2 ± 0.7 clips/patient; mean device time, 90 ± 66 minutes). One patient died within 30 days, which was not device or procedure related.

TR was graded as severe or worse at baseline in 169 of 173 patients in the TEER group and 163 of 165 in the control group. At 1 year, moderate or less TR was seen in 126 of 143 patients in the TEER group and 8 of 141 patients in the control group (based on the number of available patients and interpretable echocardiographic data).

The win ratio for the primary endpoint was 1.48 (95% CI, 1.06-2.13; P = .02) based on 11,348 wins for the TEER group, 7,643 wins for the control group, and 11,634 ties. Rates of death or tricuspid valve surgery and HF hospitalization were similar between the TEER and control groups (9.5% vs 10.6% and 0.21 vs 0.17 events per patient-year, respectively). The KCCQ score improved by ≥ 15 points in 49.7% (73/147) in the TEER group and 26.5% (39/148) in the control group, with the magnitude of change appearing to favor TEER in subgroup analyses.

For the secondary endpoints, freedom from major adverse events at 30 days was 98.3% in the TEER group (P < .001); there was a mean increase in KCCQ score at 1 year of 12.3 ± 1.8 points in the TEER group and 0.6 ± 1.8 points in the control group (P < .001), 87% (140/161) and 4.8% (7/146) in the TEER and control groups, respectively, had TR of no more than moderate at 30 days (P < .001); and 6MWT changed by a mean of –8.1 ± 10.5 m and –25.2 ± 10.3 m in the TEER and control groups, respectively (P = .25).

Investigators concluded that TEER for severe TR was associated with reduced TR severity and improved QOL at 1 year, with no apparent between-group differences in mortality or rates of HF hospitalization.