Abbott's TriClip Shows Sustained Benefits for Tricuspid Regurgitation Patients in Two-Year Study
Key Insights
TRILUMINATE Pivotal trial data reveals Abbott's TriClip (search) system significantly reduced heart failure (search) hospitalizations compared to medical therapy alone (0.19 vs. 0.26 events/patient-year, p=0.02) in patients with tricuspid regurgitation (search).
The transcatheter edge-to-edge repair device demonstrated sustained improvements in tricuspid regurgitation (search) severity, with 84% of TriClip (search) patients achieving moderate or less TR versus 21% in the control group after two years.
Patients receiving TriClip (search) experienced significant quality-of-life improvements, maintaining an average 15-point increase in KCCQ scores throughout the two-year follow-up period.
Abbott announced compelling two-year data from its TRILUMINATE Pivotal trial demonstrating that the TriClip (search) transcatheter edge-to-edge repair (TEER) system provides sustained benefits for patients with tricuspid regurgitation (search) (TR). The late-breaking results, presented at the American College of Cardiology's Annual Scientific Session (ACC.25) and simultaneously published in Circulation, show significant improvements in TR severity, reduced hospitalizations, and enhanced quality of life compared to medical therapy alone.
Tricuspid regurgitation (search) occurs when the tricuspid valve (search) fails to close properly, allowing blood to flow backward into the right atrium. This condition forces the heart to work harder, causing symptoms like fatigue and shortness of breath. If left untreated, TR can progress to atrial fibrillation (search), heart failure (search), and ultimately death.
Significant Reduction in Heart Failure Hospitalizations
The TRILUMINATE Pivotal trial, the first randomized controlled study evaluating transcatheter repair with TriClip (search) versus medical therapy alone, demonstrated that patients treated with TriClip experienced significantly fewer heart failure (search) hospitalizations (HFH) compared to the control group (0.19 vs. 0.26 events/patient-year, p=0.02).
Notably, control patients who crossed over to receive TriClip (search) after the first year of the trial showed a marked decrease in HFH following the procedure, dropping from 0.5 to 0.35 events/patient-year. More than half of eligible control patients (142 of 241) opted to receive TriClip therapy after the crossover option became available.
Sustained Improvement in TR Severity
After two years, 84% of patients in the TriClip (search) group achieved a reduction in TR to moderate or less (grade ≤ 2), compared to only 21% in the medical therapy group. Similar improvements were observed in crossover patients, with 81% achieving moderate or less TR within 30 days of receiving TriClip, up from just 3% prior to the procedure.
Dr. Saibal Kar from Los Robles Regional Medical Center in Thousand Oaks, California, who presented the findings, emphasized the clinical significance: "When we combine this with the consistent quality-of-life improvements people who receive the TriClip (search) system experience, it's clear that the benefits for patients with TR are very meaningful and TriClip offers a safe, effective and sustainable way to repair the tricuspid valve (search)."
Enhanced Quality of Life
Quality of life measurements showed substantial improvements in patients receiving TriClip (search) therapy. Treatment group patients maintained an average improvement of more than 15 points on the Kansas City Cardiomyopathy Questionnaire (KCCQ) score throughout the two-year follow-up. The KCCQ is a validated self-assessment tool measuring social abilities, symptoms, and quality of life. Similarly, patients who crossed over from the control group achieved an average 13-point improvement in KCCQ scores after receiving TriClip.
"These new data reinforce the critical role TriClip (search) plays in helping people with tricuspid regurgitation (search) 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 (search), 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."
Expanding Treatment Options for High-Risk Patients
The TriClip (search) system represents a significant advancement for patients who are not candidates for open-heart surgery and continue to experience symptoms despite medical therapy. The minimally invasive procedure allows for tricuspid valve (search) repair without the risks associated with traditional surgery.
The TRILUMINATE Pivotal trial assessed a composite primary endpoint of all-cause mortality or tricuspid valve (search) surgery, heart failure (search) hospitalizations, and quality-of-life improvement measured by the KCCQ score. After two years, TriClip (search) continued to demonstrate superiority compared to medical therapy while meeting secondary endpoints related to recurrent heart failure hospitalizations and freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention.
Global Availability
The TriClip (search) system has received regulatory approval in more than 50 countries worldwide, including the United States, Europe, and Canada. This widespread availability provides an important treatment option for the estimated millions of patients suffering from tricuspid regurgitation (search) globally.
As the first randomized controlled trial of its kind, the TRILUMINATE Pivotal study provides robust evidence supporting the use of transcatheter edge-to-edge repair for tricuspid regurgitation (search). The sustained benefits observed at two years suggest that TriClip (search) offers a durable solution for patients with this challenging cardiac condition.
For patients with severe TR who are not surgical candidates, these results confirm that TriClip (search) provides meaningful clinical improvements while reducing the burden of hospitalizations and enhancing quality of life.