A randomized clinical trial showed that adding Abbott’s MitraClip device to standard drug-based therapies improved survival and helped reduce rehospitalizations—reducing a composite score of the two risks by 43%—in patients with a leaky heart valve that had been damaged by advanced heart failure.
After two years, the study met its primary and secondary endpoints in mitral regurgitation, where small amounts of blood flow backward through the heart from the left ventricle. Mitral regurgitation is one of the most common heart valve diseases and affects one in 10 adults over the age of 75.
The transcatheter repair device clips together the flaps of the mitral valve to help reduce the backflow, forming a better seal and allowing the heart to pump blood more efficiently. It was first approved by the FDA in 2013 to treat the primary, degenerative form of mitral regurgitation caused by an anatomic defect.
Abbott said it plans to submit the new study data to the FDA to expand the MitraClip’s indications to secondary mitral regurgitation in ailing heart failure patients. The latest, third generation of the device was approved by the agency in July, with new steering and positioning capabilities, as well as a second clip size.
"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,” said co-principal investigator Gregg Stone, M.D., director of cardiovascular research and education at NewYork-Presbyterian/Columbia University Irving Medical Center and a professor of medicine at the Columbia University Vagelos College of Physicians and Surgeons, in a release.
The study was presented in a late-breaking session at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics annual symposium in San Diego and were published in the New England Journal of Medicine.
In the trial, treatment with MitraClip plus medical therapies showed reduced heart failure hospitalization rates over two years, at 35.8% per year compared to 67.9% with drug treatments alone. All-cause mortality was reduced over the same time, from 46.1% of patients in the control group to 29.1% in the device group.