title: Five-year results of the Multicenter Randomized Controlled Open-Label Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Diabetic Patients with De Novo Native Coronary Artery Lesions (SCORPIUS) study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.
abstract: BACKGROUND
  Because a delayed arterial healing response after drug-eluting stent implantation has raised concerns about safety in diabetic patients, long-term effects of treatment with sirolimus-eluting stent (SES), as compared with bare-metal stent (BMS), have to be established. The aim of the 5-year follow-up of the randomized, controlled, open-label multicenter SCORPIUS study was to assess long-term safety and efficacy of the CYPHER (Cordis, Johnson & Johnson, Bridgewater, NJ) SES in percutaneous coronary intervention of diabetic patients.
  
  
  METHODS
  A total of 190 patients with type 2 diabetes mellitus were randomized to receive either a SES (n = 95) or a BMS (n = 95). Dual-antiplatelet therapy (aspirin plus clopidogrel) was prescribed for at least 6 months. Clinical follow-up data were scheduled at 1, 8, and 12 months and 5 years.
  
  
  RESULTS
  Treatment with SES resulted in a 16% decrease in the rate of major adverse cardiac events (36% vs 52%; hazard ratio 0.6, 95% CI 0.4-0.9; P = .02). This reduction in major adverse cardiac events with SES at 5 years was mostly attributable to a lower number of repeat target lesion revascularization (13% vs 29%; hazard ratio 0.4, 95% CI 0.2-0.7; P = .003). No differences between groups were observed for safety end points (all-cause mortality 21% vs 21%, cardiac death 15% vs 13%, repeat myocardial infarction 8% vs 9%, and stent thrombosis 5% vs 6%) at 5 years.
  
  
  CONCLUSIONS
  The 5-year follow-up of the SCORPIUS trial demonstrates the long-term antirestenotic efficacy of SES in diabetic patients with significantly reduced target lesion revascularization and comparable rates of mortality, myocardial infarction, and stent thrombosis compared with BMS.
authors.affiliation: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn, Germany.
authors.forename: Jan-Malte
authors.initials: JM
authors.lastname: Sinning
authors.forename: Dietrich
authors.initials: D
authors.lastname: Baumgart
authors.forename: Nikos
authors.initials: N
authors.lastname: Werner
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: Frank M
authors.initials: FM
authors.lastname: Baer
authors.forename: Franz
authors.initials: F
authors.lastname: Hartmann
authors.forename: Helmut
authors.initials: H
authors.lastname: Drexler
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Motz
authors.forename: Heinrich
authors.initials: H
authors.lastname: Klues
authors.forename: Wolfram
authors.initials: W
authors.lastname: Voelker
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfannebecker
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Stoll
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000494:pharmacology*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus