Abbott announces new analyses of COAPTTM Trial
Abbott announced new analyses of the landmark COAPTTM Trial that show the company's MitraClipTM device is cost effective and is projected to increase both life-expectancy and quality of life compared to guideline-directed medical therapy alone in heart failure patients with secondary mitral regurgitation (MR), or a leaky mitral heart valve. The cost-effectiveness analysis also showed additional benefits of MitraClip, including decreased use of health resources after implantation. In addition, a second late-breaking data presentation at TCT showed that over a longer-term follow-up period within the COAPT Trial, MitraClip continued to remain safe, with durable MR reduction, reduced hospitalization rates, and improved survival and quality of life compared to medical therapy alone. In tandem, the two late-breaking data sets provide strong evidence of MitraClip's impact on treating secondary MR. Significant secondary MR has historically been difficult to manage, is associated with a poor prognosis, and can lead to reduced quality of life, recurrent hospitalizations and decreased survival. The COAPT Trial cost-effectiveness analysis demonstrated: Transcatheter mitral valve repair using MitraClip in patients with significant secondary MR was projected to increase life-expectancy by 1.13 years and quality-adjusted life-years by 0.82 years. TMVr using MitraClip in patients with significant secondary MR yielded an "Incremental Cost-Effectiveness Ratio" of $55,600 per quality-adjusted life year vs GDMT. The health economic data from the COAPT Trial is the first time a pre-specified economic analysis was integrated into a pivotal randomized controlled trial that involved a mitral valve repair device. Results show that, compared with guideline directed medical therapy , TMVR using MitraClip was: Safe, provided continued reduction in MR, reduced the rate of heart failure hospitalizations; Improved survival at 36 months; Provided durable improvements in quality of life at 24 months compared to medical therapy. The three-year clinical results may further help inform a coverage review being conducted by the Centers for Medicare & Medicaid Services' for an expanded National Coverage Determination of the procedure, the company said. CMS anticipates issuing a proposed decision memo in February 2020 and will issue a final decision in May 2020.