COAPT Trial Summary
COAPT trial was an open label, multicentered, parallel-group and industry-sponsored randomized controlled trial investigating the outcomes with ‘transcatheter mitral valve repair with MitraClip device’ vs. ‘guideline directed medical & device therapy only’ in heart failure patients with dilated cardiomyopathy (CM) (both ischemic and non-ischemic) who had moderate to severe and severe secondary (functional) mitral regurgtation. In addition, these patients were NYHA class II, III or IVa, had LVEF >=20% &<=50%, had LVEDD <=7mm, were on maximally tolerated GDMT and CRT (if indicated), were determined not to be apprpriate for mitral valve surgery, and did not have HCM, RCM, infiltrative CM or constritive pericarditis. Primary end point of all heart failure hospitalization within 24 months was significantly lower in the MitraClip device group (hazard ratio of 0.53; NNT 3.1). Primary safety end point of freedom from MitraClip device-related complications at 12 months was better (at 96.6%) than the set performance goal (of 88%). All 10 prespecified secondary end point were in favor of MitraClip device, including statistically significant lower all-cause mortality within 24 months (NNT of 5.9) and better quality of life.