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Study by Cardiologists at Northwestern Memorial Reveals a High Percentage of Heart Patients Receive Off-Label and Untested Drug-Coated Stents

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May 9, 2007

Chicago -

One-year follow-up showed patients receiving stents off-label or untested faired similarly to patients who fit FDA criteria for standard use

A one-year study of roughly 5,500 patients who underwent angioplasty for the insertion of drug-eluting stents (DES) found that nearly half of those patients—some 47 percent—did not fit the standard, approved indications for use set by the Food & Drug Administration.  The study, which appears in the May 9 issue of JAMA, observed that at the one-year mark, absolute event rates for the occurrences of complications associated with DES implantation, such as clotting and even death, were virtually no different from patients who received DES under the FDA’s indications for approved use.  Furthermore, the study also demonstrated durable efficacy in preventing re-narrowing of the artery.

“We set out to systematically evaluate and compare the frequency of use, the safety and the effectiveness of drug-eluting stents in off-label and untested use versus standard use,” said Nirat Beohar, MD, department of cardiology at Northwestern Memorial Hospital and assistant professor of medicine at Northwestern University’s Feinberg School of Medicine. “Our results showed that patients are receiving stents that are either off-label or untested nearly half of the time.  And, we were pleasantly surprised to learn that these patients faired just as well as those who received the stents under standard use.” 

DES represent the newest generation of stents in that they are coated with drugs that are meant to prevent the instance of blood clots.  As Beohar explains, current FDA indications for DES use are narrowly defined and therefore many heart patients’ symptoms will not fit the criteria.  However, as the study concludes, use of DES outside of the FDA’s approved guidelines has proliferated.  This is largely due to the emergence of clinical trials that deem “off-label” and “untested” DES use as being safe and effective. 

For the purposes of this study, off-label use meant that patients received the DES although they did not meet approved indications, and untested stents were those where the safety and effectiveness of the DES had not been established for the applied use or treatment.  

The study reviewed records for 7,752 percutaneous coronary intervention treated patients from 140 hospitals and medical centers.  Roughly 90 percent of those patients received DES.  Of that lot, 84 percent received DES and no other devices.  It was then determined that roughly 95 percent, or 5,541, of those patients either received standard, off-label and untested use for DES, and it was this subgroup that was examined and followed for the purpose of this study.  The research measured in-hospital, 30-day and one-year outcomes in an observational, prospective and multicenter registry.

Last UpdateFebruary 8, 2011