Navigation Links
Study looks at off-label use of biliary stents

BOSTON 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 todays 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 BIDMCs Cardiovascular Institute decided to take a closer look.

The authors determined that biliary stent implants among PVD patients increased 21.4 percent, from 227,145 in 2003 to 275,795 in 2006; approximately 1 million biliary stents were implanted off-label in the peripheral vasculature in total. Additionally, using the publicly available MAUDE (Manufacturer and User Facility Device Experience) database -- a compilation of serious adverse events and malfunctions associated with medical devices that have been reported to the FDA -- the authors reviewed all reports involving biliary stents between 2003 and 2006. During this time period, 1,036 confirmed biliary-stent malfunctions were reported, 81.2 percent of which occurred during off-label use. Malfunctions were most often due to premature stent dislodgement, premature deployment or failure of the catheter/delivery system.

In addition, notes Maisel, 87.9 percent of the 561 adverse events associated with biliary stent use during the study period occurred during off-label use, with retained product, additional catheter procedures or surgery being the most common adverse events. Thirteen patient deaths were reported during off-label use. Like the malfunctions, we found that many more adverse events occurring during the use of biliary stents in peripheral blood vessels than when they were used in a biliary or gastrointestinal location, he adds.

Our analysis raises several important issues, says Maisel. The frequent off-label use of biliary stents for treatment of peripheral vascular disease implies an unmet clinical need in the management of these patients. With the aging of the U.S. population, the number of patients with vascular disease can be expected to grow. Efforts should be directed at improving the evaluation of devices used to treat peripheral vascular disease in order to better identify those patients that will most benefit from this promising therapy.


Contact: Bonnie Prescott
Beth Israel Deaconess Medical Center

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
(Date:11/27/2015)... ... , ... There is only one major question facing all law firms in ... question has not been an easy question to answer. Especially when the senior partners ... workforce don’t share the same discipline around working long hours. , In addition ...
(Date:11/27/2015)... ... November 27, 2015 , ... According to an ... the University of Toronto and the University of British Columbia suggested that laws requiring ... injuries. The article explains that part of the reason for the controversial conclusion is ...
(Date:11/27/2015)... ... 27, 2015 , ... The rapid speed at which Americans ... more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions becoming ... The forgotten part of this equation: 80 percent of medical care occurs in ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... safe and convenient way to dispense prescription medications at home, so he invented ... way to monitor and dispense prescription medications. In doing so, it could help ...
(Date:11/27/2015)... ... November 27, 2015 , ... Lizzie’s Lice Pickers just announced ... offering customers 10% off of their purchase of lice treatment product. In addition, customers ... According to a company spokesperson. “Finding lice is a sure way to ruin the ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , Países Bajos, November 26, 2015 ... terapia fotodinámica de Bremachlorin para el cáncer avanzado. ... inmunoterapia con la terapia fotodinámica de Bremachlorin para el ... nuevo enfoque combina la inmunoterapia con la terapia fotodinámica ... Clinical Cancer Research . --> Clinical ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and Markets ... "Asia Pacific Cardiac Pacemaker Market Outlook to 2019 - Rise ... the Demand " report to their offering. ... --> Boston scientific and others. ... players including Medtronic, Biotronik, Boston scientific ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
Breaking Medicine Technology: