title: Novel approaches for preventing or limiting events in diabetic patients (Naples-diabetes) trial: a randomized comparison of 3 drug-eluting stents in diabetic patients.
abstract: BACKGROUND
  To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients.
  
  
  RESULTS
  Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group (P=0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P=1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P=0.012) and the Taxus group (adjusted P=0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P=0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P=0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P=0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P=0.048).
  
  
  CONCLUSIONS
  The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.
authors.affiliation: Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy. carlobriguori@clinicamediterranea.it
authors.forename: Carlo
authors.initials: C
authors.lastname: Briguori
authors.forename: Flavio
authors.initials: F
authors.lastname: Airoldi
authors.forename: Gabriella
authors.initials: G
authors.lastname: Visconti
authors.forename: Amelia
authors.initials: A
authors.lastname: Focaccio
authors.forename: Gianluca
authors.initials: G
authors.lastname: Caiazzo
authors.forename: Bruno
authors.initials: B
authors.lastname: Golia
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Biondi-Zoccai
authors.forename: Bruno
authors.initials: B
authors.lastname: Ricciardelli
authors.forename: Gerolama
authors.initials: G
authors.lastname: Condorelli
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017023:Coronary Angiography; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003925:Diabetic Angiopathies / Q000401:mortality / Q000628:therapy*; D003930:Diabetic Retinopathy / Q000628:therapy; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D010865:Pilot Projects; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus