Abbott has reported analyses of the landmark COAPT trial, which reveals that the company’s MitraClip device is cost-effective, while increasing life expectancy and quality of life.
Researchers compared the device to guideline-directed medical therapy (GDMT) in heart failure patients with secondary mitral regurgitation (MR) or a leaky mitral heart valve.
Abbott’s cost-effectiveness analysis also revealed additional benefits of MitraClip, including decreased use of health resources following implantation.
Additionally, data showed that MitraClip remained safe over a longer-term follow-up period within the COAPT trial.
COAPT Trial co-principal investigator Gregg Stone said: “With longer-term follow-up, we continue to see extended benefits from treatment with MitraClip in advanced heart failure patients with severe mitral regurgitation and are encouraged by the latest findings demonstrating it is also a cost-effective treatment.
“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.”
The trial analysis demonstrated that 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.
Earlier, data from the trial had demonstrated the benefits of the device to select heart failure patients with clinically significant secondary MR.
The new three-year data provides crucial insights into the durability of MitraClip.
Compared with guideline-directed medical therapy, TMVR using MitraClip was safe, providing a continued reduction in MR and reduced the rate of heart failure hospitalisations.
The data trial also showed improved survival at 36 months and provided significant improvements in quality of life at 24 months when compared to medical therapy.
Abbott said in a statement: “The three-year clinical results may further help inform a coverage review being conducted by the Centers for Medicare & Medicaid Services’ (CMS) for an expanded National Coverage Determination of the procedure.”
CMS expects to issue a proposed decision memo on the device in February and anticipates a final decision by next May.
In July, the US Food and Drug Administration (FDA) approved Abbott’s MitraClip G4 heart valve repair device for the treatment of patients with mitral regurgitation.