Peripheral artery disease (PAD) is a major cause of limb loss. It is estimated that PAD affects between 8.5 and 12 million Americans, with a prevalence that has increased by about 25 percent over the preceding decade.
Vijaya B. Kolachalama, PhD, FAHA, assistant professor of medicine at Boston University School of Medicine (BUSM), and his colleagues aim to address this issue. He has been awarded a $2.1 million R01 grant from the National Institutes of Health's (NIH) National Heart, Lung, and Blood Institute. Using machine learning, image processing, physics-driven modeling as well as experimental and animal studies, Kolachalama and his colleagues will establish algorithms and models to understand the mechanisms of drug delivery and optimize device design for treating PAD.
While interventional devices such as drug-coated balloons (DCBs) are effective at treating PAD, recent studies suggest the potential for DCBs to cause harm. This has prompted the FDA to issue a warning that ultimately led to a marked reduction of the clinical use of DCBs.
According to Kolachalama, this response by the clinical and regulatory communities underscores a need to develop next-generation DCBs that could show improved efficacy and safety profiles. "Drawing from our previous experience related to studies on drug-eluting stents and more recently on DCBs, we will engineer the next generation of DCBs with improved efficacy and safety profiles to help restore DCB treatment options for patients with PAD," he explains.
The researchers will seek to predict optimal DCB designs for both acute and sustained drug delivery using a model that computes mechanical interactions during DCB use.
The proposed project builds upon a history of collaboration between BUSM, Massachusetts General Hospital and the University of South Carolina in the targeted area of translational research in cardiovascular disease.
It constitutes a novel and timely study on an emergent therapeutic approach and includes an aspect of mechanistic discovery that holds relevance in the broader domain of endovascular technologies."
Vijaya B. Kolachalama, PhD, FAHA, assistant professor of medicine, Boston University School of Medicine
A part of the U.S. Department of Health and Human Services, the NIH is the largest biomedical research agency in the world.