The 614 symptomatic heart failure patients with moderate-to-severe or severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone at 78 sites in the US and Canada in the COAPT (cardiovascular outcomes assessment of the MitraClip percutaneous therapy for heart failure patients with Functional Mitral Regurgitation) trial.
The late-breaking data from two separate analyses of the COAPT trial demonstrated additional benefits from treatment with MitraClip for heart failure patients with clinically significant secondary mitral regurgitation (MR) or leaky heart valve.
MitraClip is a small and clip-based device developed to repair MR without the requirement for open-heart surgery. It is delivered to the heart via small incision in the leg.
Abbott’s structural heart business vice president Michael Dale said: “These additional analyses from the landmark COAPT Trial point to the advantages of MitraClip treatment for patients with severe MR who are not benefitting from medical therapy.”
At 24 months, the COAPT quality-of-life analysis demonstrated that patients with heart failure and secondary MR receiving maximally-tolerated medical therapy and treated with the device demonstrated substantial and sustained health status improvement compared with medical therapy.
The patients treated with MitraClip demonstrated substantial improvement in the KCCQ-OS score, while quality-of-life was unchanged over time in the medical therapy group. KCCQ-OS score is a self-assessment of social abilities, symptoms and quality-of-life.
The patients have been screened to evaluate the severity of secondary MR prior to enrolment in the trial in the COAPT imaging sub-analysis. It is also designed to determine which patient characteristics best predict favorable long-term outcomes with MitraClip.
A specific imaging protocol was developed and deployed to select patients with severe MR who might benefit from the device.
According to the company, a substantial reduction in death and heart failure hospitalizations was observed in all imaging subgroups regardless of patients’ baseline characteristics.
COAPT trial co-principal investigator Gregg Stone said: “Following the groundbreaking data from the COAPT Trial presented last September, these analyses further confirm that treatment with MitraClip provides great benefit for select patients with advanced heart failure.”
Separately, the company also secured expanded approval for the MitraClip to treat secondary mitral regurgitation. The approval was based on date form the COAPT trial data.
