Abbott (ABT) announced positive clinical study results from a randomized controlled trial comparing treatment with the MitraClip device to guideline-directed medical therapy in select patients with secondary (or functional) mitral regurgitation, or a leaky heart valve, as a result of advanced heart failure.
The landmark COAPT study met both the primary safety and efficacy endpoints and all secondary endpoints, and showed treatment with MitraClip plus medical therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years.
The therapeutic mitral valve intervention is the first and only to demonstrate positive outcomes in a clinical trial for ailing heart failure patients with clinically significant secondary mitral regurgitation.
The COAPT study data will be submitted to the U.S. Food and Drug Administration to support consideration of an expanded indication for Abbott’s MitraClip to treat secondary mitral regurgitation.
MitraClip repairs the mitral valve without the need for an invasive surgical procedure and is delivered to the heart through the femoral vein, a blood vessel 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, thereby relieving symptoms and improving patient quality of life.
The device was approved by the FDA in 2013 to treat the primary (or degenerative) form of mitral regurgitation (MR), which is caused by an anatomic defect of one or more of the structures of the mitral valve, which prevents the valve from closing properly, and subsequently causes leakage. Approximately one in 10 adults age 75 and older in the U.S., or four million Americans, suffer from MR.
The COAPT trial investigated MitraClip for treating secondary MR, a type of MR in which the damaged left ventricle of the heart – often due to a heart attack or other cause of heart failure – impairs the performance of a normal mitral valve. The COAPT data add to more than 10 years of evidence on the use of MitraClip for treating primary MR, and now provide randomized trial evidence supporting MitraClip as a possible option to treat secondary MR.
It’s estimated that two to three times as many patients may benefit from MitraClip treatment for secondary MR as a result of underlying heart failure, than those treated now for the primary form of the disease commonly associated with age.