New Late-Breaking Analyses from COAPT Trial Show Benefits of Abbott’s MitraClip

Abbott announced positive late-breaking data from two separate analyses of the COAPT Trial showing additional key benefits from treatment with MitraClip for heart failure patients with clinically significant secondary (or functional) mitral regurgitation (MR), or leaky heart valve. Both data sets were presented at the American College of Cardiology’s (ACC) 68th Annual Scientific Session. On Thursday, the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for MitraClip to treat secondary mitral regurgitation based on the COAPT Trial data. During the late-breaking session at ACC, MitraClip was shown to be superior to guideline-directed medical therapy in providing quality-of-life improvements for select patients with significant secondary MR resulting from advanced heart failure. These data were simultaneously published in the Journal of the American College of Cardiology.A second sub-analysis measured baseline characteristics of heart failure patients prior to enrollment in the COAPT Trial and indicated that all subgroups of patients enrolled in the trial benefited from MitraClip therapy in the long-term.

“Following the groundbreaking data from the COAPT Trial presented last September, these analyses further confirm that treatment with MitraClip provides great benefit for select patients with advanced heart failure,” said Gregg W. Stone, M.D., co-principal investigator of the COAPT Trial, director of cardiovascular research and education at NewYork-Presbyterian/Columbia University Irving Medical Center and professor of medicine at Columbia University Vagelos College of Physicians and Surgeons. “In patients who remained symptomatic with moderate-to-severe or severe MR, despite all the best medical treatments, MitraClip prolonged their survival and markedly reduced the need for hospitalizations while improving their daily lives — despite advanced age and comorbidities.” People with heart failure may develop secondary MR when the left chamber of the heart becomes enlarged, preventing the mitral leaflets from closing and allowing blood to flow backwards through the heart. Significant secondary MR is difficult to manage, is associated with a poor prognosis, and can lead to reduced quality of life, recurrent hospitalizations and decreased survival.  Most heart failure patients with clinically significant secondary MR are treated with medication only and have few treatment options. However, based on the recent approval, these patients can now benefit from treatment with MitraClip for their secondary MR.

MitraClip is a small, clip-based device that repairs MR without the need for open-heart surgery. It is delivered to the heart through a small incision in the leg. The device works by clipping together a portion of the leaflets of the mitral valve to reduce the backflow of blood, which allows the heart to pump blood more efficiently. Approximately one in 10 adults age 75 and older in the U.S., or four million Americans, suffer from MR. It’s estimated that two to three times as many patients may now benefit from MitraClip treatment for secondary MR as a result of underlying heart failure than those treated for the primary form of the disease commonly associated with the deterioration of the valve structure. “These additional analyses from the landmark COAPT Trial point to the advantages of MitraClip treatment for patients with severe MR who are not benefitting from medical therapy,” said Michael Dale, vice president of Abbott’s structural heart business. “The data underscore our recent approval to help these people who desperately need treatment, giving them the ability to do the things many of us take for granted: things like breathing normally, lying down to sleep and walking to the mailbox.”  – Medical Buyer Bureau