Abbott’s TriClip Evaluated in Quality-of-Life Analysis From TRILUMINATE Pivotal Trial

October 26, 2023—An in-depth health status analysis of the TRILUMINATE pivotal trial found that tricuspid transcatheter edge-to-edge repair (T-TEER) provided substantial benefits in terms of symptoms, functional status, and quality of life compared to medical therapy in patients with severe tricuspid regurgitation (TR).

These findings were reported at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. Simultaneously, Suzanne V. Arnold, MD, et al published the findings online in Journal of the American College of Cardiology.

According to the TCT press release, TRILUMINATE, which compared T-TEER using the TriClip device (Abbott) versus medical therapy, demonstrated no difference with respect to death or heart failure hospitalizations at 1 year, but there was a significant improvement in patient-reported health status with T-TEER. The pivotal trial data was presented at TCT on October 24.

The Abbott-funded in-depth analysis of the health status outcomes in the TRILUMINATE pivotal trial was performed to describe the timing, magnitude, and consistency of the health status benefits and to estimate the biologic correlates of health status after the procedure and the clinical relevance of the health status benefit.

The trial randomized patients with severe TR to T-TEER (n = 175) with TriClip or medical therapy alone (n = 175). Health status was assessed at baseline as well as at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and at baseline, 1 month, and 12 months with the Medical Outcomes Study Short-Form 36 (SF-36) Health Survey.

The primary health status endpoint was the KCCQ overall summary score (KCCQ-OS; range 0-100, in which higher is better) that was compared between treatment groups using mixed effects linear regression. “Alive and well” at 1 year was defined as KCCQ-OS ≥ 60 and no decline from baseline > 10 points.

As summarized in the TCT press release, T-TEER—compared with medical therapy alone—resulted in significantly greater improvement in the KCCQ-OS at 1 month (mean between-group difference 9.4 points; 95% CI, 5.3-13.4) with a small additional improvement at 1 year (mean between-group difference 10.4 points; 95% CI, 6.3-14.6). Improvements in quality of life were greater among those patients with the most severe symptoms. Interaction analyses demonstrated that the benefit of T-TEER diminished as baseline KCCQ-OS increased.

T-TEER patients were also more likely to be alive and well at 1 year compared to patients who received medical therapy alone (74.8% vs 45.9%; P < .001) with a number needed to treat of 3.5 to derive benefit.

“As with any medical procedure, the impact on a patient’s quality of life is an important factor in assessing its success,” commented Dr. Arnold in the TCT press release. “Compared with medical therapy alone, T-TEER resulted in substantially better health status at 1 month that was sustained through 1 year. These findings support the use of T-TEER with the transcatheter tricuspid valve repair system for improvement in the symptoms, functional limitations, and quality of life in patients with severe TR.”

Dr. Arnold is a cardiologist at Saint Luke’s Mid America Heart Institute and Professor of Medicine, University of Missouri-Kansas City School of Medicine in Kansas City, Missouri.