Abbott has released new data from its TRILUMINATE Pivotal trial, revealing that the TriClip system for transcatheter edge-to-edge repair (TEER) eases the severity of tricuspid regurgitation (TR) symptoms. The findings show a decrease in heart failure hospitalizations and long-term benefits for patients' quality of life over two years. The data were announced at the American College of Cardiology's Annual Scientific Session in Chicago and published in Circulation.
TR, a condition where the heart pump function is compromised, leads to symptoms like fatigue and shortness of breath. If untreated, it can cause more severe conditions or result in death. The TriClip system is targeted at patients unsuitable for surgery who have persistent or recurring TR symptoms despite medical treatment.
The TRILUMINATE study highlighted that after two years, the TriClip system surpassed medical therapy in reducing recurrent heart failure hospitalizations and ensuring freedom from all-cause mortality, tricuspid valve surgery, and interventions. Notably, more than half of the control group opted to switch to TriClip treatment.
Two-year results include a significant reduction in heart failure hospitalizations for those treated with TriClip. The event rate was lower compared to the control group, and among control patients who switched to the device, hospitalizations dropped significantly.
The system showed a lasting reduction in TR severity for 84% of the treated patients compared to 21% in the control group, with similar improvements for crossover patients after receiving the TriClip. Quality of life improvements were also noted, with patients scoring over 15 points higher on the Kansas City Cardiomyopathy Questionnaire, which measures quality of life impacted by symptoms.
Dr. Saibal Kar from Los Robles Regional Medical Center stated, "With the TRILUMINATE Pivotal two-year results, tricuspid transcatheter edge-to-edge repair with the TriClip device for severe, symptomatic tricuspid regurgitation reduced heart failure hospitalizations compared to the control group. Improvements in tricuspid regurgitation severity and quality of life were sustained through two years."
Sandra Lesenfants, senior vice president of Abbott's structural heart business, emphasized, "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."
The TRILUMINATE trial is a pioneering study comparing TriClip's TEER system with medical therapy. Its focus is the safety and effectiveness of this treatment for severe TR. TriClip is approved in over 50 countries, including the U.S., Europe, and Canada.
Abbott, a significant player in the healthcare sector, operates globally with products across diagnostics, medical devices, nutritionals, and branded generic medicines. For more information, visit their website and social media channels.