Dec 13th 2018

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT)

Stone GW, Lindenfeld J, Abraham W et al. N Engl J Med 2018; 379:2307-2318  

COAPT is a multicenter trial that randomized 614 symptomatic patients with moderate-to-severe or severe functional mitral regurgitation despite maximal guideline-directed medical therapy to percutaneous mitral valve repair using MitraClip (Abbott Structural, Santa Clara, CA) or medical therapy alone. Patients were randomized in 1:1 fashion. Hospitalizations for heart failure at 24 months was reduced in the MitraClip group (36% vs. 68% in the medical therapy arm). Death from any cause was reduced in the MitraClip group (29% vs. 46% in the medical therapy arm). Freedom from device-related complications at 12 months was 97%. The U.S. Food and Drug Administration, in 2019, approved the use of the MitraClip system for treatment of patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function despite being treated with optimal medical therapy.