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Results from the COAPT Economic Analysis Reported at TCT 2019 and Published Simultaneously in Circulation

SAN FRANCISCO – September 29, 2019 – Results of a new economic analysis of the COAPT trial data found that transcatheter mitral valve replacement (TMVr) combined with guideline-directed medical therapy (GDMT) is a cost-effective treatment strategy for patients with heart failure and severe secondary mitral regurgitation (MR).

Findings were reported today at the 31^st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. The results were also published simultaneously in Circulation.

Two-year data from the randomized COAPT trial found that patients with heart failure and secondary mitral regurgitation who remained symptomatic despite maximally tolerated medical therapy demonstrated reduced rates of hospitalizations and death, as well as improved quality-of-life and functional capacity after being treated with the transcatheter MitraClip device. These results were first reported at TCT 2018 and published in the New England Journal of Medicine.

Using data from the COAPT trial, researchers performed a formal, patient-level economic analysis of TMVr with GDMT versus GDMT alone in patients with heart failure with moderate-to-severe or severe secondary MR from the perspective of the United States healthcare system.  Observed in-trial data were used to project long-term patient-level survival, health utilities (a measure of quality of life), and costs.

The analysis found that, although follow-up costs were approximately $11,000 per patient lower with TMVr with GDMT compared with GDMT alone ($26,654 vs. $38,345; p=0.018), cumulative two-year costs remained substantially higher with TMVr due to the up-front cost of the index procedure ($73,416 vs. $38,345; p<0.001).  When in-trial survival, health utilities, and costs were modeled over a lifetime horizon, TMVr was projected to increase quality-adjusted life-years (QALYs) by 0.82 years at a cost of $45,648, yielding a lifetime incremental cost-effectiveness ratio (ICER) of $55,600/QALY gained. In the United States, an ICER less than $50,000/QALY gained is considered high value, while an ICER less than $150,000/QALY gained is considered to be of intermediate value. The results remained consistent across a variety of sensitivity and subgroup analyses. 

“The cost-effectiveness of TMVr for the COAPT population is comparable to that of other commonly used technologies for the treatment of heart failure, including implantable cardiac defibrillators, and is substantially more cost-effective than the use of continuous-flow left ventricular assist devices for destination therapy,” said Suzanne J. Baron, MD, MSc, Director of Interventional Cardiology Research at Lahey Hospital and Medical Center in Burlington, MA. “Together with the improved clinical outcomes in the COAPT trial, these findings suggest that TMVr is a reasonable treatment strategy for this patient population based on both clinical and economic considerations.”

The COAPT study was funded by Abbott. Dr. Baron disclosed research funding and advisory board compensation from Boston Scientific Corp and consulting fees from Edwards Lifesciences.