title: Outcome of sirolimus-eluting versus zotarolimus-eluting coronary stent implantation in patients with and without diabetes mellitus (a SORT OUT III Substudy).
abstract: Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first-generation Cypher Select+ sirolimus-eluting stent (SES). We randomized 2,332 patients to treatment with ZESs (n = 1,162, n = 169 diabetics) or SESs (n = 1,170, n = 168 diabetics) and followed them for 18 months. Randomization was stratified by presence/absence of diabetes. The primary end point was major adverse cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated with an increased risk of major adverse cardiac events (18.3% vs 4.8%, hazard ratio 4.05, 95% confidence interval 1.86 to 8.82), myocardial infarction (4.7% vs 0.6%, hazard ratio 8.09, 95% confidence interval 1.01 to 64.7), target vessel revascularization (14.2% vs 3.0%, hazard ratio 4.99, 95% confidence interval 1.90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated with a considerable increased risk of adverse events in patients with diabetes at 18-month follow-up.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.forename: Lisette O
authors.initials: LO
authors.lastname: Jensen
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Tilsted
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.forename: Henning
authors.initials: H
authors.lastname: Kelbaek
authors.forename: Ulrik
authors.initials: U
authors.lastname: Abildgaard
authors.forename: Anton
authors.initials: A
authors.lastname: Villadsen
authors.forename: Jens
authors.initials: J
authors.lastname: Aarøe
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.forename: Lars R
authors.initials: LR
authors.lastname: Krusell
authors.forename: Evald H
authors.initials: EH
authors.lastname: Christiansen
authors.forename: Hans E
authors.initials: HE
authors.lastname: Bøtker
authors.forename: Steen D
authors.initials: SD
authors.lastname: Kristensen
authors.forename: Jan
authors.initials: J
authors.lastname: Ravkilde
authors.forename: Morten
authors.initials: M
authors.lastname: Madsen
authors.forename: Henrik T
authors.initials: HT
authors.lastname: Sørensen
authors.forename: Klaus
authors.initials: K
authors.lastname: Rasmussen
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Jens F
authors.initials: JF
authors.lastname: Lassen
mesh_terms: D054058:Acute Coronary Syndrome / Q000453:epidemiology / Q000628:therapy*; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000628:therapy*; D003920:Diabetes Mellitus / Q000453:epidemiology*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D019233:Retreatment; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: C489443:zotarolimus; D020123:Sirolimus