Tricuspid transcatheter edge-to-edge repair (TEER) reduced the severity of tricuspid regurgitation (TR) at 1 year and was associated with an improved QOL in patients with severe tricuspid regurgitation. These were the main findings of the prospective, randomized TRILUMINATE trial.
Severe TR is a common, debilitating condition that is associated with impaired survival and poor QOL. Transcatheter tricuspid therapies have recently emerged, but their benefit had not been studied in a randomized, controlled clinical trial. TRILUMINATE (NCT03904147) was designed to evaluate the safety and effectiveness of medical therapy alone or percutaneous TEER for severe TR using the TriClipTM G4 Delivery System.1 Key inclusion criteria were severe, symptomatic TR; stable guideline-directed medical and/or device therapy for heart failure for at least 30 days; at least intermediate risk of morbidity/mortality with tricuspid valve surgery; and left ventricular ejection fraction greater than 20%.
First author Paul Sorajja, MD, said more than 450 participants had thus far been enrolled at 65 centers in the US, Canada, and Europe; he went on to present the main results of the first 350 patients at the 2023 American College of Cardiology annual meeting.2 Participants were randomly assigned to TEER (N=175) or medical therapy (N=175). The mean age was 78, and 54.9% were women. The primary endpoint was a composite assessed hierarchically of all-cause death or number of participants with tricuspid valve surgery; hospitalization for HF; and QOL improvement assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year. The secondary endpoints were: 1) freedom from major adverse events (MAE) after procedure attempt at 30 days (in the experimental group only); 2) change in QOL as measured with the KCCQ; 3) TR reduction to moderate or less at 30 days; and 4) change in 6-minute walking distance (6MWD) at 12 months.
Results for the primary endpoint favored the TEER group (win ratio, 1.48; 95% CI, 1.06–2.13; P=0.02). Dr. Sorajja noted that this result was driven mainly by the improvement in QOL. The incidence of death or tricuspid-valve surgery and hospitalization for heart failure in both groups were similar. The KCCQ score improved by a mean (±SD) of 12.3±1.8 points, as compared with 0.6±1.8 points in the control group (P<0.001). TR was reduced by TEER to moderate or less in 87% of patients, compared with only 4.8% in the control group; this reduction was sustained for 1 year of follow-up. The degree of TR reduction was related to the degree of improvement in QOL. The 30-day MAE rate was only 1.7%; death and pacemaker implant both occurred in 0.6%. Survival without valve surgery was high at 1 year in both groups: around 90%.
“These results are very meaningful for a highly symptomatic population whose quality of life is impacted by TR,” said Dr. Sorajja. “With the excellent benefit-to-risk ratio of the TriClip system, a historically untreated population will have a treatment option to improve their quality of life.”
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