The authors report a significant difference in clinical outcome for patients in the off-label group was clearly evident by the 30-day follow-up. "Both observed and adjusted analyses indicated a greater than two-fold higher risk of death, MI [myocardial infarction, heart attack], or stent thrombosis [formation of a blood clot]," they write.
"Compared with standard use, short-term outcomes appear to be worse with off-label and untested use," the authors conclude. "However, even with off-label or untested use of drug-eluting stents, overall absolute event rates both in hospital and at 12 months following PCI remain relatively low."
(JAMA. 2007;297:1992-2000. Available pre-embargo to the media at www.jamamedia.org.)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Higher Rate of Adverse Outcomes Associated With Off-Label Use of Drug-Coated Stents
In a related article, Htut K. Win, M.D., M.R.C.P, of Baylor College of Medicine, Houston, and colleagues report that off-label use of drug-eluting stents is more common than on-label use and is associated with a persistently higher rate of adverse angiographic and clinical outcomes.
The authors assessed rates of major adverse cardiac events during the index admission and one year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features. They analyzed data from 3,323 patients enrolled in the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry, who received at least one drug-eluting stent between July 2004 and September 2005. The authors evaluated composite clinical outcomes of death, heart attack, or t
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Contact: Kris Lathan
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JAMA and Archives Journals
8-May-2007