TRILUMINATE Illuminates—Coverage of ACC.23 | SCAI

At the American College of Cardiology Scientific Sessions, 2023, held in New Orleans, Drs. Sorajja and colleagues presented the 12-month results of the TRILUMINATE pivotal clinical trial (Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal; NCT03904147). TRILUMINATE is a prospective randomized control trial comparing transcatheter edge-to-edge repair (TEER) to optimal medical therapy alone for patients with symptomatic severe tricuspid regurgitation. 350 patients (mean age 78 years, 54.9% female) were randomized from 65 centers throughout the United States, Canada, and Europe. The primary endpoint was a hierarchical composite including all-cause mortality or tricuspid valve surgery, heart failure hospitalization, and quality of life improvement quantified by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Analysis of the primary composite endpoint favored TEER: WIN ratio .48; 95% CI 1.06-2.13; p=0.02. However, this was driven primarily by KCCQ quality-of-life score improvement (TEER vs. optimal medical therapy: 12.3±1.8 points vs. 0.6±1.8 points; p<0.001), while rates of mortality, tricuspid valve surgery, and heart failure hospitalization did not differ between groups. Overall, TEER was found to be safe (30-day major adverse event rate of only 1.7%) and also effective (30-day moderate or less TR of 87.0%). The early findings of this pivotal study have generated vigorous debate regarding the role of tricuspid valve TEER for severe TR. First, which patients with TR are most likely to benefit from TEER? Second, is quality-of-life improvement alone the most important driver for procedural indication? Third, are these early results sufficient to merit on-label approval at this time? While the cardiology and interventional community look forward to longer-term data from TRILUMINATE down the line, other pivotal studies such as CLASP IITR (Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial; NCT 04097145) are eagerly awaited to further delineate the safety, efficacy, and role for tricuspid valve TEER.