title: Long-term clinical and angiographic outcomes of diabetic patients after revascularization with early generation drug-eluting stents.
abstract: BACKGROUND
  Early generation drug-eluting stents (DESs) reduce restenosis and repeat revascularization procedures. However, the long-term safety and efficacy of early generation DES according to diabetic status are poorly established.
  
  
  METHODS
  A total of 1,012 patients were randomly assigned to treatment with sirolimus-eluting (n = 503) or paclitaxel-eluting stents (n = 509). Serial angiographic follow-up at baseline, 8 months, and 5 years was available in 293 patients with 382 lesions. The primary end point was a composite of major adverse cardiac events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization). Clinical and angiographic outcomes through 5-year follow-up were compared between diabetic and nondiabetic patients.
  
  
  RESULTS
  Major adverse cardiac events were more common among diabetic than nondiabetic patients at 5 years (25.9% vs 19.2%, hazard ratio [HR] 1.45, 95% CI 1.06-1.99, P = .02). The difference in disfavor of diabetic patients was largely determined by a higher rate of cardiac mortality (11.4% vs 4.3%, HR 2.86, 95% CI 1.69-4.84, P < .0001), whereas the risk of myocardial infarction (6.5% vs 6.8%, HR 1.00, 95% CI 0.55-1.84, P = .99) and ischemia-driven target lesion revascularization (14.4% vs 14.1%, HR 1.09, 95% CI 0.73-1.64, P = .67) was comparable. The risk of stent thrombosis was similar among diabetic and nondiabetic patients (definite or probable: 6.0% vs 4.6%, HR 1.36, 95% CI 0.71-2.67, P = .35). Among 293 patients undergoing serial angiography, very-late lumen loss amounted to 0.42 ± 0.63 mm in diabetic patients and 0.44 ± 0.68 mm in nondiabetic patients (P = .79).
  
  
  CONCLUSIONS
  Diabetic patients remain at increased risk for mortality after revascularization with early generation DES during long-term follow-up. Conversely, diabetes is no longer associated with an increased risk of clinical and angiographic restenosis after revascularization with early generation DES.
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Michael
authors.initials: M
authors.lastname: Billinger
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.forename: Sarah
authors.initials: S
authors.lastname: Hitz
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.forename: Christoph
authors.initials: C
authors.lastname: Stettler
authors.forename: Thomas
authors.initials: T
authors.lastname: Zanchin
authors.forename: Cedric
authors.initials: C
authors.lastname: Pulver
authors.forename: Nico
authors.initials: N
authors.lastname: Pfäffli
authors.forename: Franz
authors.initials: F
authors.lastname: Eberli
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Bindu
authors.initials: B
authors.lastname: Kalesan
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods / Q000401:mortality*; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003920:Diabetes Mellitus / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology*; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D020123:Sirolimus / Q000494:pharmacology*; D016019:Survival Analysis; D013995:Time; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D020123:Sirolimus