Startlingly positive results from a clinical trial of Abbott’s MitraClip heart valve device reportedly drew applause at the annual Transcatheter Cardiovascular Therapeutics meeting in San Diego yesterday.
Abbott (NYSE:ABT) acquired MitraClip in the $410 million acquisition of Evalve back in 2009. The device, which is designed to reshape the mitral valve to prevent blood from flowing backwards through the valve, won its first FDA nod in 2013.
Yesterday results from a study of the device in heart failure patients with functional mitral regurgitation showed sharp reductions in hospitalization and mortality rates in the MitraClip arm.
The trial’s 614 patients were randomized to either MitraClip plus medical therapy or medical therapy alone. Of the 302 patients in the MitraClip arm, the annual hospitalization rate at two years was 35.8%, compared with 67.9% for the control arm, a -47.2% reduction. The annual mortality rate at two years was -36.9% lower for the MitraClip arm at 29.1%, according to the study, which was also published in the New England Journal of Medicine. There was a 96.6% rate of freedom from device-related complications after a year, according to the study.
“These highly anticipated results from the COAPT trial are quite remarkable, and conclusively demonstrate that heart failure patients with clinically significant secondary mitral regurgitation who remain symptomatic despite best medical practices benefit from treatment with MitraClip,” co-principal investigator Dr. Gregg Stone, who presented the data at TCT, said in prepared remarks. “These results have the potential to transform clinical practice and help patients who otherwise have an extremely poor prognosis – patients who, to date, have had to rely only on medications to manage their symptoms without treating the underlying cause.”
“Abbott has led the way in developing minimally invasive solutions for some of the most complex challenges in patients with structural heart disease, and the COAPT study results show that MitraClip has the potential to help many more people with heart failure live better and longer, impacting both quality of life and survival,” added structural heart CMO Dr. Neil Moat. “While MitraClip is already the gold standard for repairing leaky heart valves in patients with primary mitral valve disease who are not surgical candidates, we now have very robust clinical evidence that MitraClip is a life-changing technology for people whose heart failure has resulted in a leaky mitral valve, providing hope to these very sick heart failure patients and their caregivers.”
Stone’s presentation at TCT 2018 drew two separate rounds of applause and an emotional reaction from him, according to theheart.org | Medscape Cardiology.
Abbott said it plans to pursue a new labeling indication from the FDA for functional mitral regurgitation, backed by the COAPT data.
The positive trial results sent ABT shares up 3.4% to $71.40 apiece today in pre-market trading.