MitraClip's success persisted throughout long-term follow-up in the trial, which entered patients with severe MR secondary to heart failure.
Outcomes were consistent across all prespecified patient subgroups, including by age, sex, MR, left ventricular function and volume, cardiomyopathy etiology, and degree of surgical risk, the researchers reported.
However, nearly half of the control patients died before becoming eligible for crossover at 2 years."We have to identify the appropriate patients for treatment and treat them early because the mortality is very high in this population," Stone said. The systolic LV dimension exclusion helped address the persistent question of whether"severe mitral regurgitation is a marker of a bad left ventricle or...contributes to the pathophysiology" of MR and its poor outcomes, Stone said.
The marked reductions in mortality and risk for adverse events and low number-needed-to-treat with MitraClip are"really remarkable," said Batchelor, who is with the Inova Heart and Vascular Institute, Falls Church, Virginia. "The dramatic difference between the treated arm and the medical therapy arm in this trial makes me feel that this therapy is here to stay," Batchelor concluded."We just have to figure out how to deploy it properly in the right patients."
MITRA-FR didn't follow patients beyond 2 years, Stone noted. Still,"we do think that the main difference was that COAPT enrolled a patient population with more severe MR and slightly less LV dysfunction, at least in terms of the LV not being as dilated, so they didn't have end-stage LV disease. Whereas in MITRA-FR, more of the patients had only moderate mitral regurgitation." And big dilated left ventricles"are less likely to benefit.
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