Results from two separate late-breaking clinical trials presented Oct. 26 during TCT 2023 – TRILUMINATE Pivotal and TRISCEND II – add to the growing body of evidence surrounding tricuspid valve repair in patients with severe tricuspid regurgitation (TR).

In a prespecified health status analysis from the TRILUMINATE Pivotal trial, simultaneously published in JACC, Suzanne V. Arnold, MD, MHA, et al., assessed data from 350 patients with severe TR who were randomized to either tricuspid-transcatheter edge-to-edge repair (T-TEER) using the TriClip system (n=175) or medical therapy alone (n=175). Patients were assessed at baseline and at one, six and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and mixed effects linear regression was used to compare between treatment groups.

Overall results found T-TEER was superior to medical therapy alone for the hierarchical composite endpoint of all-cause death or tricuspid-valve surgery, heart failure (HF) hospitalization, and increase of ≥15 points on the KCCQ overall summary score, with a win-ratio of 1.48. Researchers noted this result was driven primarily by the health status results, with no meaningful between-group differences in mortality or HF hospitalization.

In other findings, T-TEER significantly improved health status at one month compared with medical therapy alone (mean between-group difference in KCCQ 9.4 points, 95% CI 5.3-13.4), with a small additional improvement at one year (mean between-group difference 10.4 points, 95% CI 6.3-14.6). T-TEER patients were also more likely to be alive and well at one year, than those assigned to medical therapy alone (T-TEER vs. medical therapy: 74.8% vs. 45.9%, p<0.001).

Based on the study results, researchers suggest that patients with lower baseline KCCQ scores, who were more likely to improve symptomatically after T-TEER, may be ideal targets for intervention. They add that "although exploratory analyses suggest that the health status benefit of T-TEER is a true biologic effect (and not just placebo), further work to clarify the placebo effect of intervention and the long-term clinical implications of health status improvement after intervention would be informative."

In the TRISCEND II trial, researchers provided an early look at the safety and effectiveness of transcatheter tricuspid valve replacement (TTVR) in the EVOQUE system based on the first 150 patients enrolled in the trial. While the rate of major adverse events was less than the expected rate (27.4% vs. 43.8%), early findings showed TTVR with EVOQUE effectively eliminated TR in a vast majority of patients despite more than 55% having massive or torrential TR and the remainder being categorized as severe, according to Susheel Kodali, MD, FACC, who presented the findings. Kodali also noted that "treatment of severe TR with the EVOQUE system resulted in meaningful improvements in functional status and symptoms at six months."

The design of TRISCEND II is based on U.S. Food and Drug Administration breakthrough designation. Additional clinical and echocardiographic endpoints from the full cohort of 400 patients, including mortality and rates of HF hospitalization will be forthcoming in the future.