Although approved by the U.S. Food and Drug Administration as a palliative treatment for cancer patients who have developed bile-duct obstructions, biliary stents are sometimes used "off-label" for the treatment of peripheral vascular disease (PVD).
A study in today's issue of the American Journal of Therapeutics finds that off-label use of biliary stents is increasing, and that the majority of adverse events and device malfunctions associated with the use of these stents occurs during off-label usage.
“Our study found that more than 1 million patients received biliary stents for ‘off-label' treatments between 2003 and 2006,” explains cardiologist William Maisel, MD, MPH, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center (BIDMC) and senior author of the study. “We also found that more than 80 percent of the reported adverse events and device malfunctions associated with these products have occurred during ‘off-label' use.”
The most common off-label use for biliary stents is treatment of peripheral arterial disease (PAD), which develops when leg arteries become narrowed by cholesterol plaques. Patients who suffer from PAD can develop pain, skin ulcers, reduced exercise tolerance and even loss of limb. The condition affects millions of patients throughout the U.S. and is a significant cause of morbidity and mortality.
“Clinical management of peripheral artery disease can be challenging,” explains Maisel. Although noninvasive treatment strategies such as exercise training can help some patients, for many others, pain and discomfort persist. In an effort to unblock the vessels, many physicians have turned to stents, flexible tubular devices which can keep the vessels propped open.
Because there is little data supporting the clinical utility and safety of biliary stents for treatment of vascular disorders, Maisel and colleague Jonathan Bridges, MD, of BIDMC's Cardiovascular Institute decided to take a closer look.