Results from the TRILUMINATE pivotal trial showcased the performance of the TriClip transcatheter edge-to-edge repair (TEER) to treat tricuspid regurgitation (TR), or a leaky heart valve. Outcomes included improvements in the severity of TR after two years.
Abbott also reported significant reductions in the rate of hospitalizations due to heart failure compared to medical therapy. The study saw long-term quality-of-life benefits for patients, too. Investigators presented data at the American College of Cardiology’s Annual Scientific Session (ACC.25) in Chicago. They simultaneously published their findings in Circulation.
TriClip offers an option for those who aren’t good candidates for surgery and continue to have symptoms or persistent TR despite treatment with medical therapy. Delivered through a vein in the leg, the TriClip TEER technology clips together a portion of leaflets. It repairs the tricuspid valve and helps blood flow in the right direction without the need for open-heart surgery. The system received FDA approval in April 2024.
More about the Abbott TRILUMINATE study findings
Abbott’s TRILUMINATE study found superiority with TriClip compared to medical therapy. It also met secondary endpoints of recurrent heart failure hospitalizations (HFH) and freedom from all-cause mortality, tricuspid valve surgery and tricuspid valve intervention.
After the first year, patients in the medical therapy group could cross over to receive TriClip therapy. More than half (142 of 241 eligible patients) received TriClip.
Investigators reported a significant reduction in HFH (0.19 vs. 0.26 events/patient-year). Control patients who switched to TriClip had a drop in HFH after receiving the device. The study also saw significant, sustained reductions in TR grade, with 84% of patients achieving a TR reduction to moderate or less. That compared to 21% of patients in the control group. For those who switched from the control, 81% achieved moderate or less TR at 30 days compared to 3% prior to crossing over.
Patients who received TriClip achieved more than a 15-point improvement on average in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score throughout follow-up. Those in the crossover group achieved similar improvements (up 13 points on average) once they received 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, SVP 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.”
