COAPT Economic Analysis Demonstrates Cost-Effectiveness of TMVR With MitraClip

September 29, 2019—The Cardiovascular Research Foundation (CRF) announced that results from a new economic analysis of the COAPT trial data were presented by Suzanne J. Baron, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California. The results were published simultaneously by Dr. Baron et al online in Circulation.

The data showed 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).

According to CRF, 2-year data from the randomized COAPT trial found that patients with heart failure and secondary MR 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 MitraClip TMVR device (Abbott).

The 2-year COAPT data were first presented by Gregg W. Stone, MD, at TCT 2018 and were published by Dr. Stone et al in The New England Journal of Medicine (2018;379:2307–2318). On September 28 at TCT 2019, Michael J. Mack, MD, presented the 3-year COAPT data.

In the current cost-effectiveness study presented by Dr. Baron, investigators used data from the COAPT trial to perform 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 health care 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 = .018), cumulative 2-year costs remained substantially higher with TMVR because of the up-front cost of the index procedure ($73,416 vs $38,345; P < .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 < $50,000/QALY gained is considered high value, whereas an ICER < $150,000/QALY gained is considered to be of intermediate value. The results remained consistent across a variety of sensitivity and subgroup analyses.

Dr. Baron commented in the CRF announcement, “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. 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.”