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by Crystal Phend, Senior Associate Editor, MedPage Today

September 23, 2018

Percutaneous repair of the mitral valve improved key outcomes in moderate-to-severe, symptomatic mitral regurgitation for heart failure patients who had exhausted pharmaceutical options, the COAPT trial showed.

The primary efficacy endpoint of heart failure hospitalizations within 24 months fell a relative 47% with MitraClip implantation compared with medical therapy alone (annualized rate 35.8% vs 67.9%, P<0.001), reported Gregg Stone, MD, of Columbia University Medical Center in New York City, at the Transcatheter Cardiovascular Therapeutics conference.

All-cause mortality at 24 months was also substantially reduced to 29.1% versus 46.1% among controls (HR 0.62, P<0.001).

The number needed to treat was 3.1 to prevent a heart failure hospitalization within 24 months and 5.9 to save one life within 24 months.

The findings, simultaneously published in the New England Journal of Medicine, follow closely on the heels of the MITRA-FR trial, which showed MitraClip did not improve 12-month all-cause mortality and unplanned heart failure hospitalization compared with medical therapy alone (54.6% vs 51.3%, P=0.53).

But both trials concurred on safety of the procedure. In COAPT, the primary safety endpoint of freedom from device-related complications at 12 months (96.6%) met the performance goal. In MITRA-FR, there was a 3.5% rate of complications requiring surgery or transfusion.

“These patients have a very bad prognosis, despite all our best medical therapies, revascularization, and CRT [cardiac resynchronization therapy],” Stone told MedPage Today.