title: On-label and off-label use of drug-eluting stents: comparison of short- and long-term outcomes.
abstract: 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.
authors.affiliation: Interventional Cardiology Department, Tehran Heart Center, Tehran University of Medical Sciences, 1411713138 Tehran, Iran. hamidrezapoorhosseini@yahoo.com
authors.forename: Hamidreza
authors.initials: H
authors.lastname: Poorhosseini
authors.forename: Seyed Ebrahim
authors.initials: SE
authors.lastname: Kassaian
authors.forename: Hasan
authors.initials: H
authors.lastname: Aghajani
authors.forename: Mohammad
authors.initials: M
authors.lastname: Alidoosti
authors.forename: Ali Mohammad
authors.initials: AM
authors.lastname: Hajizeinali
authors.forename: Mojtaba
authors.initials: M
authors.lastname: Salarifar
authors.forename: Ebrahim
authors.initials: E
authors.lastname: Nematipour
authors.forename: Ali Reza
authors.initials: AR
authors.lastname: Amirzadegan
authors.forename: Mahmood
authors.initials: M
authors.lastname: Sheikhfathollahi
authors.forename: Nahid
authors.initials: N
authors.lastname: Shafiee
authors.forename: Elham
authors.initials: E
authors.lastname: Hakki-Kazazi
authors.forename: Masoumeh Lotfi
authors.initials: ML
authors.lastname: Tokaldany
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage; D016009:Chi-Square Distribution; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D019983:Guideline Adherence; D017052:Hospital Mortality; D006801:Humans; D007492:Iran; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage; D017410:Practice Guidelines as Topic; D011356:Product Labeling; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage; D013927:Thrombosis / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D017239:Paclitaxel; D020123:Sirolimus