"Of the 3,323 patients, 1,817 (54.7 percent) had at least one off-label characteristic," the authors report.
During the index hospitalization, the composite clinical outcome occurred in 198 (10.9 percent) patients in the off-label group and 76 (5.0 percent) patients in the on-label group.
"The primary composite outcome occurred more often in the off-label group," they write. "This difference was primarily due to a higher frequency of MI [heart attack] in the off-label group."
There was no difference in the death rate between the two groups at one year. The composite outcome and stent thrombosis occurred more often in the off-label group.
"Several specific off-label angiographic and clinical characteristics seemed to be associated with the highest incidence of adverse clinical events," the authors conclude. "Clinicians should be cautious about extrapolating the benefits of drug-eluting stents compared with bare-metal stents that were observed in randomized clinical trials to higher-risk clinical settings that have not been assessed."
(JAMA. 2007;297:2001-2009. 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.
Editorial: The Enigma of Drug-Eluting Stents
In an accompanying editorial, Robert A. Harrington, M.D., and E. Magnus Ohman, M.D., of Duke University Medical Center, Durham, North Carolina, write that drug-eluting stenting is clearly a breakthrough technology - but clinicians must be careful not to succumb to the hope and hype of a product based on limited approval data.
"Clinicians must take advantage of all the information sources available (RCTs
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Contact: Kris Lathan
312-926-2963
JAMA and Archives Journals
8-May-2007