Five-year data from the COAPT trial demonstrated the safety and efficacy of MitraClip for people with mitral regurgitation (MR).
Data also showed the superiority of the TriClip transcatheter edge-to-edge repair (TEER) system. The Triluminate pivotal study evaluated TriClip against medical therapy in patients with tricuspid regurgitation (TR).
Abbott presented results at the American College of Cardiology’s 72nd Annual Scientific Session together with the World Congress of Cardiology. The event took place in New Orleans. Results for both trials published simultaneously in The New England Journal of Medicine.
Abbott proves MitraClip’s safety and efficacy
Five-year COAPT results showed that MitraClip can cut the rate of hospitalizations while improving survival. It demonstrated this in a population of heart failure patients with severe secondary (or functional) MR.
The trial randomized patients to receive MitraClup treatment plus guideline-directed medical therapy, or just the medical therapy alone. Primary results through two years found MitraClip superior to guideline-directed medical therapy. After five years, Abbott said it observed even more “substantial benefits” for patients.
Abbott observed a significantly reduced risk of annual hospitalizations (33% per year for MitraClip against 57% in the control). MitraClip also reduced the risk of death by almost 30% (57% vs. 67%) and achieved durable MR reduction. Reduced MR occurred in 95% of patients.
Data follows similar one-year results from the COAPT study reported last June.
“With nearly two decades of clinical experience in transcatheter mitral repair, Abbott’s MitraClip has paved the way for innovation in helping people with mitral regurgitation, providing an alternative to surgery for patients who often need treatment to survive,” said Michael Dale, SVP of Abbott’s structural heart business. “These results reinforce that MitraClip plays a critical role in not only improving the symptoms of people with this serious heart condition, but also getting them back to living their fullest lives.”
TriClip meets composite primary endpoint
Abbott’s Triluminate pivotal study evaluates the superiority of TriClip compared to medical therapy in patients with severe, symptomatic TR. These patients are at intermediate or greater risk for open-heart surgery.
The TEER device demonstrated superiority to the control group, primarily driven by quality of life improvement. Abbott said mortality or tricuspid valve surgery and heart failure hospitalizations appeared no different between groups at one year.
Abbott said TriClip demonstrated a significant reduction in TR grade in 87% of patients at 30 days. That compares to 4.8% in the control. TR reduction registered as sustained and durable at one year.
The study found that 50% of patients who received TriClip achieved at least a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life) at one year. That compares to 26% in the control group.
Abbott also said that TriClip presented a strong safety profile. At 30 days, 1.7% of patients who received TriClip experienced major adverse events. None underwent urgent surgery or experienced endocarditis. Abbott observed zero occurrences of device embolization or device thrombus.
“These Triluminate pivotal data show TriClip is the first minimally invasive device therapy for the treatment of tricuspid regurgitation to provide durable improvements in TR severity and quality of life that go beyond taking medication to manage symptoms,” Dale said. “When left unaddressed, TR can be debilitating and life-threatening. By repairing the damage caused by structural heart disease, TriClip G4 and our latest technological innovations are helping people reclaim their lives so they can get back to doing what they love.”