title: Long-term outcome of sirolimus-eluting and zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a Danish organization for randomized trials on clinical outcome III substudy).
abstract: We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZES and SES had similar MACE rates at 5-year follow-up but SES was associated with a significantly higher risk of definite stent thrombosis (10 [1.0%] vs 23 [2.3%]; OR 0.43, 95% CI 0.20 to 0.91, p = 0.028). Moreover, during the last 4 years, ZES had fewer MACE, TVR, and stent thrombosis events among nondiabetic patients. In conclusion, SES remains superior to ZES in patients with diabetes throughout the 5-year follow-up, however, among nondiabetic patients, SES demonstrated a highly dynamic performance with favorable initial results followed by a late catch-up that included an overall higher risk of stent thrombosis.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Kevin K W
authors.initials: KK
authors.lastname: Olesen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark.
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Lisette O
authors.initials: LO
authors.lastname: Jensen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Lars R
authors.initials: LR
authors.lastname: Krusell
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark.
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Evald H
authors.initials: EH
authors.lastname: Christiansen
authors.affiliation: Department of Clinical Epidemiology, Aalborg University Hospital, Aarhus, Denmark.
authors.forename: Morten
authors.initials: M
authors.lastname: Madsen
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.affiliation: Department of Clinical Epidemiology, Aalborg University Hospital, Aarhus, Denmark.
authors.forename: Henrik T
authors.initials: HT
authors.lastname: Sørensen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Jens F
authors.initials: JF
authors.lastname: Lassen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. Electronic address: michael.maeng@ki.au.dk.
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
mesh_terms: D019917:Blood Vessel Prosthesis Implantation / Q000379:methods*; D016022:Case-Control Studies; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis; D048909:Diabetes Complications; D003920:Diabetes Mellitus; D054855:Drug-Eluting Stents; D005260:Female; D006083:Graft Occlusion, Vascular; D006801:Humans; D008297:Male; D009203:Myocardial Infarction; D011475:Prosthesis Failure; D012086:Reoperation; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D013927:Thrombosis; D016896:Treatment Outcome
chemical_list: C489443:zotarolimus; D020123:Sirolimus