ACC25: Abbott’s TriClip Reduces Heart Failure Hospitalizations

Abbott revealed late-breaking data from its TRILUMINATE pivotal trial that demonstrates the TriClip transcatheter edge-to-edge repair (TEER) system for tricuspid regurgitation (TR) offers substantial, sustained TR severity improvements after two years. TriClip was also found to reduce hospitalization rate due to heart failure compared to medical therapy.

The data was presented at the American College of Cardiology’s (ACC) annual scientific session and published in the journal Circulation.

The TRILUMINATE trial is the first randomized, controlled clinical study to evaluate the safety and effectiveness of transcatheter repair with the TriClip system compared to medical therapy alone in people with severe TR. The primary endpoint was a composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations, and quality-of-life improvement measured by the KCCQ score. 

After the first year of the trial, patients in the control group (medical therapy) were allowed to cross over to receive TriClip therapy, and over half (142 of 241 eligible patients) received TriClip.

The rate of heart failure hospitalizations (HFH) was lower in the TriClip treatment group compared to the control group (medical therapy) with 0.19 vs. 0.26 events per patient-year. The control patients who switched to TriClip also had a drop in HFH after getting the device—0.5 vs. 0.35 events per patient year.

There was significant TR reduction to moderate or less in 84% of patients with TriClip vs. 21% in patients in the control group. In control group patients who crossed over, 81%achieved moderate or less TR at 30 days after received the device.

TriClip patients had an over 15-point improvement on average in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life) throughout follow-up. Patients in the crossover group achieved similar improvements in KCCQ score (+13 points on average) once implanted with TriClip.

“These new data reinforce the critical role TriClip plays in helping people with tricuspid regurgitation live the life they want while reducing the risk of hospitalization,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “Patients battling TR face serious challenges, including increased risk of heart failure, as a result of this debilitating condition. Unfortunately, many are not eligible for open-heart surgery and had limited treatment options prior to the approval of TriClip, a significant advancement that allows patients to reclaim their lives.”

TriClip is approved for use in more than 50 countries, including in the U.S., Europe, and Canada.