• COAPT Substudy: MitraClip Costs More Than Medical Therapy Alone But Provides ‘Acceptable’ Economic Value in Patients with Heart Failure, Secondary MR

    SAN FRANCISCO – In patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation, edge-to-edge transcatheter mitral valve repair (TMVr) with the MitraClip plus maximally tolerated guideline-directed medical therapy (GDMT) is a “reasonable” strategy, both clinically and economically, according to a cost-effectiveness substudy of the COAPT trial presented Sunday at Transcatheter Cardiovascular Therapeutics (TCT) 2019.

    The COAPT trial’s original results, presented at TCT 2018 and subsequently published in The New England Journal of Medicine, showed significantly lower composite rate of all-cause mortality or heart-failure hospitalizations at 2-year follow-up in patients randomized to treatment with MitraClip (Abbott) plus maximally tolerated GDMT as compared with GDMT alone.

    Three-year results were presented Saturday and showed that this benefit of MitraClip plus GDMT over GDMT alone continued.

    Investigators in the cost-effectiveness substudy used the COAPT trial’s 2-year data to perform a formal, patient-level economic analysis of TMVr plus GDMT compared to GDMT alone from the perspective of the U.S. health-care system. Investigators assessed costs for the index TMVr hospitalization by using a combination of resource-based accounting and, when available, hospital billing data. They estimated follow-up medical-care costs on the basis of medical resource use collected during the COAPT trial, according to a manuscript by Suzanne J. Baron, MD, MSc, of Saint Luke’s Mid-America Heart Institute, Kansas City, Missouri, and colleagues simultaneously published in Circulation.

    TMVr’s initial cost was $48,198, largely driven by the cost of the TMVr procedure ($35,755, of which $30,000 is the cost of the MitraClip device alone). TMVr did have significantly lower follow-up costs than GDMT ($26,654 vs. $38,345; p=0.018), but the 2-year cumulative cost was still significantly higher with TMVr because of the up-front cost of the index procedure (total 2-year cost TMVr $73,416 vs. GDMT $38,345; p<0.001), the manuscript says.

    Baron and colleagues reported that when the observed COAPT trial results were projected over a lifetime horizon, TMVr was associated with substantial gains in life expectancy and quality-adjusted life expectancy at an incremental cost of approximately $45,000 per patient. The resulting incremental cost-effectiveness ratios for TMVr compared with GDMT were $55,600 per quality-adjusted life-year gained and $40,361 per life-year gained, values the investigators said are near or below the thresholds considered to represent high economic value for cardiac therapies in the U.S.

    They noted that while TMVr can be considered reasonably cost-effective, it should not be considered a cost-saving strategy because of the high initial cost.

    This remains true even when the MitraClip device cost is assumed to be zero, Baron said during a press conference announcing the trial results. The reason for that, she said, has to do with the survival benefit conferred by treatment using the device.

    “Patients who live longer utilize more health-care resources,” she said. “And so even with a free device, while certainly, yes, the costs were lower, it still wasn’t cost saving.”

    An editorial by Robert O. Bonow, MD, MS, of the Northwestern University Feinberg School of Medicine, Chicago, and colleagues that accompanied the manuscript by Baron and colleagues generally supported their findings. However, the editorial noted the discrepancy between COAPT and another randomized trial comparing treatment with MitraClip plus medical therapy to medical therapy alone, MITRA-FR, which showed no benefit for TMVr.

    Bonow and colleagues said it appears that the most cost-effective therapy for most heart-failure patients with secondary MR is GDMT. However, for a subset of patients who look like those in the COAPT trial, who remain symptomatic despite optimized GDMT and have moderate-to-severe or severe secondary MR, “TMVr offers the exciting potential for substantial improvements in longevity and quality of life, while also providing society good value for its health care dollars.”

    “In 21st-century medicine, that win-win scenario is often as good as it gets,” Bonow and colleagues wrote.

    Because of the COAPT trial design, which allowed patients in the GDMT-alone arm to cross over into the TMVr arm after 2 years, Baron and colleagues said that whether the economic benefit of the MitraClip would be sustained in the long term would never be known. They said more studies focusing on the sustainability of the device’s economic benefit are needed.

    The COAPT trial and cost-effectiveness substudy were funded by Abbott.

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