title: Paclitaxel-eluting stents compared with bare metal stents in diabetic patients with acute myocardial infarction: the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial.
abstract: BACKGROUND
  In the prospective, randomized Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, implantation of paclitaxel-eluting stents (PES) safely reduced the rates of ischemic target lesion revascularization (TLR) compared with bare metal stents (BMS) in patients with ST-segment-elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention. Diabetes mellitus is a known predictor of adverse outcomes after percutaneous intervention in STEMI. We therefore sought to assess the impact of PES in diabetic patients with STEMI from the HORIZONS-AMI trial.
  
  
  RESULTS
  A total of 478 patients with diabetes and 2527 without diabetes were randomly assigned to receive PES versus BMS. The 12-month rates of ischemic TLR were significantly reduced by PES compared with BMS in both diabetic (11.2% versus 5.2%; hazard ratio [95% confidence interval]=0.45 [0.21 to 0.93]; P=0.03) and nondiabetic (6.8% versus 4.3%, hazard ratio [95% confidence interval]=0.63 [0.44 to 0.92]; P=0.02) patients. In patients with insulin-treated diabetes, PES compared with BMS reduced the 12-month TLR rate from 21.4% to 7.3% (hazard ratio [95% confidence interval]=0.35 [0.12 to 1.03]; P=0.046). Angiographic late loss and binary restenosis at 13 months were also significantly reduced in PES-treated diabetic patients. There were no significant differences between the BMS and PES groups in the 12-month rates of death, reinfarction, stroke, or stent thrombosis in either diabetic or nondiabetic patients.
  
  
  CONCLUSIONS
  In the large-scale, prospective, randomized HORIZONS-AMI trial, implantation of PES compared with BMS in patients with STEMI and diabetes mellitus resulted in significant reductions in ischemia-driven TLR and angiographic restenosis at 1 year, with comparable safety outcomes, including stent thrombosis. These results suggest that PES can safely be used to reduce restenosis in high-risk diabetic patients presenting with STEMI.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.
authors.affiliation: Charité Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Jan Z
authors.initials: JZ
authors.lastname: Peruga
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Brodie
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.forename: Franz
authors.initials: F
authors.lastname: Hartmann
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Hood
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Eugenia
authors.initials: E
authors.lastname: Nikolsky
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003925:Diabetic Angiopathies / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
chemical_list: D008670:Metals; D017239:Paclitaxel