The TRILUMINATE Pivotal trial reports a reduction in the severity of tricuspid regurgitation with TEER, but no significant difference in survival or hospitalization after one year of follow-up.
A tricuspid transcatheter edge-to-edge repair (TEER) system reduced the severity of tricuspid regurgitation and improved quality of life compared with medical therapy in patients with severe, symptomatic tricuspid regurgitation.
However, the data from the TRILUMINATE Pivotal trial, presented in a late-breaking session at the American College of Cardiology (ACC) 2023 Annual Scientific Sessions, suggest the minimally invasive valve repair procedure was not associated with a significant difference in survival or hospitalization after 1-year of follow-up.
“Patients with tricuspid regurgitation, when treated with transcatheter edge-to-edge repair (TEER) with the TriClip device, experienced significant improvements in quality of life,” said Paul Sorajja, MD, chair of the Valve Science Center at the Minneapolis Heart Institute Foundation and lead author of the study. “In a patient population with a high symptom burden, this is a meaningful benefit.”
Untreated severe tricuspid regurgitation has been linked to significant morbidity and often with a poor quality of life, leading to refocused attention on treatment options to treat clinical outcomes. Now, TEER has emerged as a safe and potentially effective therapy for treatment of tricuspid regurgitation. The procedure utilizes a transvenous approach and approximates tricuspid-valve leaflets by deploying a clip to hold the leaflets together and reduce tricuspid regurgitation without the need for cardiac surgery.
In the TRILUMINATE trial, which was sponsored by Abbott, patients from 65 centers in the United States, Canada, and Europe were eligible for inclusion if they had symptomatic severe tricuspid regurgitation. The trial consisted of a randomized cohort in which patients were randomly assigned to receive TEER or to continue with the best available medical therapy, and a single-arm cohort in which all patients received TEER.
Primary endpoints for the trial were a hierarchical composite that included death from any cause or tricuspid-valve surgery, hospitalization for heart failure, and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ). An improvement was defined as an increase of at least 15 points in the KCCQ score (range, 0 to 100, with higher scores indicating better quality of life) at the 1-year follow-up.
The trial enrolled a total of 350 patients from 65 centers between August 2019 and September 2021, with 175 patients assigned to each group. The mean age of participants was 78 years and 54.9% of the patients were women. Data showed the severity of tricuspid regurgitation was categorized as grade 4 or 5 (massive or torrential) in 239 of the 338 patients who could be evaluated (70.7%) and baseline characteristics were well-matched between the groups.
Results for the primary endpoint favored the TEER group, with 11,348 wins for the TEER group, 7643 wins for the control group, and 11,634 ties between the groups. The win ratio for the primary endpoint was reported as 1.48 (95% confidence interval [CI], 1.06 to 2.13; P = .02). However, the incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups.
Patients in the TEER group experienced significant improvements in quality-of-life scores with an average increase of 12.3 points, compared with control patients experiencing an average increase of 1 point. At the 30-day mark, 87.0% of patients in the TEER group and 4.8% in the control group had tricuspid regurgitation of no greater than moderate severity (P <.001).
Safety endpoints suggest TEER as safe, with 98.3% of patients who underwent the procedure being free from major adverse events at 30 days. An ongoing study, the TRILUMINATE Pivotal trial will continue to follow these patients for five years.