SAN FRANCISCO – MitraClip’s lower rates of mortality and heart failure rehospitalization over optimal medical therapy remained significant at 3 years, according to the latest COAPT trial results presented Saturday at Transcatheter Cardiovascular Therapeutics 2019.
The cumulative incidence of all-cause death or heart failure rehospitalization at 3 years was 58.8% in the MitraClip plus maximally tolerated guideline-directed medical therapy (GDMT) and 88.1% for GDMT alone (p<0.001). The number needed to treat to see benefit is 3.4 patients (95% confidence interval, 2.7, 4.6], according to data presented by Michael Mack, MD, of The Heart Hospital Baylor Plano, Plano, Texas.
The COAPT trial randomized 614 symptomatic heart failure patients with moderate-to-severe or severe secondary mitral regurgitation (MR) on maximally tolerated medical therapy. Patients in the GDMT-alone arm were allowed to cross over to MitraClip (Abbott) after they passed the 24-month trial follow-up time period. At that time, 18.6% of the eligible patients crossed over. Patients not eligible to cross over included those who died, received a heart transplant or who were implanted with a left ventricular assist device.
The rate of mortality or heart failure rehospitalization following crossover was 28% at approximately 12 months. Panelists at a press conference announcing the results noted that this 1-year mortality rate was similar to that of patients who received the MitraClip to begin with, showing that even a late MitraClip implantation provided benefit for study patients on GDMT alone who survived for two years without the device.
This study was funded by Abbott.