Late-breaking data from the TRILUMINATE clinical study showed the superiority of the TriClip system, and five-year follow-up data from the COAPT trial showed that MitraClip therapy reduced the risk of hospitalisations by almost half
Abbott announced that its TriClip transcatheter edge-to-edge repair (TEER) system is superior to medical therapy in treating patients with tricuspid regurgitation (TR), who are at risk for open-heart surgery.
The announcement is based on late-breaking data from the TRILUMINATE clinical study, which evaluated the safety and effectiveness of the TriClip system compared to medical therapy.
The TRILUMINATE trial met its composite primary endpoint, establishing the superiority of the TriClip system compared to the control group, driven by improvement in quality of life.
In the study, 87% of patients who received the TriClip system experienced a significant reduction in TR grade to moderate or less, at 30 days compared to 4.8% of patients in the control group.
The system also contributed to significant improvement in quality of life, and a strong safety profile, with no reports of device embolisation or device thrombus.
Abbott structural heart business senior vice president Michael Dale said: “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.
“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.”
In a separate development, Abbott announced that its MitraClip therapy shows long-term benefits in treating leaky valves in people with mitral regurgitation (MR), based on five-year data from the COAPT trial.
The study results showed that MitraClip is safe and effective and can cut the rate of hospitalisations while improving survival for heart failure patients with severe secondary MR.
Severe secondary MR is a consequence of left ventricular (LV) dysfunction, where a leaky valve allows blood to flow back through the mitral valve.
In the COAPT trial, patients with severe secondary MR were randomised to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone.
The five-year patient follow-up data from the COAPT trial showed that MitraClip therapy significantly reduced the risk of annualised hospitalisations by almost half.
It also reduced the risk of death by almost 30%, and achieved durable MR reduction in 95% of patients from moderate-to-severe or severe to mild or moderate, said the US medical device maker.
COAPT trial co-principal investigator Gregg W Stone said: “Secondary mitral regurgitation is difficult to diagnose and manage, and is often associated with a poor prognosis.
“These five-year COAPT results further confirm that MitraClip is safe and effective at treating secondary MR in advanced heart failure patients, durably reducing hospitalisations and helping patients live longer.”