On Sept. 29, 2019, 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 (GDMT) alone in heart failure patients with secondary mitral regurgitation (MR), or a leaky mitral heart valve.
The data was presented at the late-breaking clinical trial session at the 31st Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in San Francisco (September 25 – 29) and simultaneously published in the journal Circulation. However, the MitraClip system (a small, clip-based device) has been commercially available in the U.S. since 2013 and in Europe since 2008.
“The pinnacle for all breakthrough therapies is to enhance patient longevity and quality of life in a cost-effective manner. These late-breaking data demonstrate that the MitraClip provides tremendous health benefits for select heart failure patients at a cost that is acceptable to the US health care system,” said Dr. Gregg W. Stone, MD.
The COAPT Trial cost-effectiveness analysis demonstrated:
- Transcatheter mitral valve repair (TMVr) 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” (ICER) of $55,600 per quality-adjusted life year vs GDMT. (ICER is a commonly used health economic measure where the lower the ICER score, the more cost-effective the therapy. An ICER score of $55,600 implies that MitraClip provides a positive health economic value, with ICER scores lower than $100,000 generally considered as cost-effective therapy.)
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.
We at Trialsite News think an economic analysis could be a very beneficial and informative practice in the clinical trial world.
Gregg W. Stone, MD, co-principal investigator of the COAPT Trial, Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine and Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai, New York
Call to Action: Do you or someone dear to you have heart failure with secondary mitral regurgitation (MR)? Learn more about Mitraclip here.