title: Comparison of the sirolimus-eluting versus paclitaxel-eluting coronary stent in patients with diabetes mellitus: the diabetes and drug-eluting stent (DiabeDES) randomized angiography trial.
abstract: The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Aarhus, Denmark. michael.maeng@ki.au.dk
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.forename: Lisette Okkels
authors.initials: LO
authors.lastname: Jensen
authors.forename: Anders Michael
authors.initials: AM
authors.lastname: Galloe
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.forename: Evald Hoej
authors.initials: EH
authors.lastname: Christiansen
authors.forename: Knud Nørregaard
authors.initials: KN
authors.lastname: Hansen
authors.forename: Steffen
authors.initials: S
authors.lastname: Helqvist
authors.forename: Hans Erik
authors.initials: HE
authors.lastname: Botker
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D048909:Diabetes Complications / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel; D020123:Sirolimus
chemical_list: D017239:Paclitaxel; D020123:Sirolimus