COAPT: 3-year outcomes from a randomized trial of the MitraClip in patients with heart failure and severe secondary mitral regurgitation
Reported from the TCT Congress 2019 in San Francisco - USA
At TCT 2019 in San Francisco - USA, Michael J. Mack presented the results of the COAPT trial. Read the summary and analysis by Nicole Karam.
One year ago, the results of COAPT study were presented at TCT 2018. This study randomized patients with secondary mitral regurgitation to optimal medical treatment alone or optimal medical treatment + transcatheter mitral valve repair (TMVR) using the MitraClip® device. Particular attention was paid to carefully select patients with severe mitral regurgitation and less severe left ventricular disease, and to optimizing medical treatment before randomization. The study met both the primary safety and efficacy endpoints and all secondary endpoints, and showed treatment with MitraClip® plus medical therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years. The results of COAPT at 3 years were revealed by Michael J. Mack during the Late-Breaking session at TCT 2019. The differences were even more dramatic than what was observed at 2-years.
In the intention-to-treat population, the results at 3 years confirmed the results observed at 2 years, with an even larger benefit derived from TMVR, in terms of decrease in heart-failure related hospitalization, and increase in survival rate, functional capacity and quality of life, compared to the medical treatment arm. The Kaplan Meier curves for the primary endpoint of death/heart failure hospitalizations for the intention-to-treat groups continued to separate at 3 years, reaching 88% for the GDMT group and 58.8% in the MitraClip group. The number needed to treat declined from 4.5 at 2 years to 3.4 at 3 years.
An interesting group addressed in the current analysis was the group of patients who crossed over from medical to intervention arm. Indeed, COAPT prohibited patients selected in the medical treatment arm from undergoing TMVR within the first 24 months; however, after 24 months, the patients were allowed to undergo TMVR. While many patients in the medical treatment group died before 2 years, patients who crossed to device arm between 24 and 36 months (38%) had a similar benefit compared to those who underwent TMVR initially, with fewer heart failure related hospitalization, and death or heart failure hospitalizations within 12 months, compared to patients who did not crossover. Undergoing transcatheter mitral valve repair was an independent predictor of freedom from the primary endpoint at 3 years (HR = 0.43; 95% CI, 0.24-0.78), as was beta-blocker use (HR = 0.57; 95% CI, 0.37-0.88).
Perspective:
The 3-year results of COAPT support our current perception that in a well selected heart failure population with persistent symptoms and severe mitral regurgitation despite optimal medical therapy, TMVR using the MitraClip® device provides both symptomatic and survival benefit, and should be considered as part of the therapeutic arsenal in this population.
Related links
To learn more about this subject, attend the following sessions at PCR London Valves 2019:
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