On-label and off-label use of drug-eluting stents: comparison of short- and long-term outcomes.

In this retrospective study, we compared the in-hospital and long-term outcomes of the on-label and off-label uses of drug-eluting stents.From April 2003 through June 2007, 1,538 patients underwent percutaneous coronary intervention with a drug-eluting stent (sirolimus or paclitaxel) at Tehran Heart Center. Off-label implantation of the drug-eluting stent was as implemented on the basis of specific clinical and procedural characteristics set forth in our text. There were 708 patients in the on-label group and 830 in the off-label group.Baseline characteristics were not significantly different between the groups. Histories of non-ST-segment-elevation myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting were more prevalent in the off-label group. Both groups had similar procedural and in-hospital complications. The follow-up rate at 1 year was 93.1% in the on-label group and 93.3% in the off-label group. During that period, the occurrence of major adverse cardiac events was not significantly different between the groups. After 1 year between the respective on- and off-label uses of the sirolimus-eluting and paclitaxel-eluting stents, and after adjustment for diabetes mellitus, myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting, there was no remarkable difference in the occurrence of major adverse cardiac events (hazard ratio, 0.688; 95% confidence interval, 0.365-1.295; P=0.2463) or target-vessel revascularization (hazard ratio, 0.69; 95% confidence interval, 0.291-1.636; P=0.3993).We found that off-label use of drug-eluting stents was safe after 1 year and that such use was not associated with increased in-hospital myocardial infarction or death.