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Htut K. Win, MD, MRCP; Angel E. Caldera, MD; Kelly Maresh, RN; John Lopez, MD; Charanjit S. Rihal, MD; Manish A. Parikh, MD; Juan F. Granada, MD; Sachin Marulkar, MS; Deborah Nassif, PhD; David J. Cohen, MD, MSc; Neal S. Kleiman, MD; for the EVENT Registry Investigators

JAMA. 2007;297(18):2001-2009.

Context  Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non–high-risk patients is unclear.

Objective  To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features.

Design, Setting, and Patients  From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration–approved indications for sirolimus- and paclitaxel-eluting stents.

Main Outcome Measures  The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated.

Results  Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval [CI], 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio [HR], 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 [0.4%] vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05).

Conclusions  Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.

Author Affiliations: Baylor College of Medicine, Houston, Tex (Drs Win and Caldera); Methodist DeBakey Heart Center, Houston, Tex–Weill Medical College of Cornell University (Ms Maresh and Drs Granada and Kleiman); University of Chicago, Chicago, Ill (Dr Lopez); Mayo Clinic, Rochester, Minn (Dr Rihal); Weill Medical College of Cornell University–New York Presbyterian Hospital, New York, NY (Dr Parikh); Harvard Clinical Research Institute, Boston, Mass (Mr Marulkar and Dr Nassif); Saint Luke's Mid America Heart Institute, Kansas City, Mo (Dr Cohen).

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