title: Long-term efficacy and safety of Zotarolimus-eluting stent in patients with diabetes mellitus: pooled 5-year results from the ENDEAVOR III and IV trials.
abstract: OBJECTIVE
  To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM).
  
  
  BACKGROUND
  Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population.
  
  
  METHODS
  Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression.
  
  
  RESULTS
  Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES.
  
  
  CONCLUSIONS
  Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts; Cardiology Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Moshe
authors.initials: M
authors.lastname: Vardi
authors.forename: David A
authors.initials: DA
authors.lastname: Burke
authors.forename: Sripal
authors.initials: S
authors.lastname: Bangalore
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pencina
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000517:prevention & control; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus
keywords: coronary artery disease; diabetes mellitus; drug-eluting stents