title: Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program.
abstract: OBJECTIVE
  The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes.
  
  
  BACKGROUND
  The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes.
  
  
  METHODS
  We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years.
  
  
  RESULTS
  The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%).
  
  
  CONCLUSIONS
  The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; The Medtronic RESOLUTE US Clinical Trial (R-US); NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [R-Int]; NCT00752128; RESOLUTE Japan-The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent [RJ]; NCT00927940).
authors.affiliation: Heart Center at the Isar, Munich, Germany. sigmund@silber.com
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Jorge
authors.initials: J
authors.lastname: Belardi
authors.forename: Petr
authors.initials: P
authors.lastname: Widimsky
authors.forename: Joe
authors.initials: J
authors.lastname: Massaro
authors.forename: Victor
authors.initials: V
authors.lastname: Novack
authors.forename: Alan C
authors.initials: AC
authors.lastname: Yeung
authors.forename: Shigeru
authors.initials: S
authors.lastname: Saito
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000453:epidemiology / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000453:epidemiology; D018795:Device Approval; D003920:Diabetes Mellitus / Q000188:drug therapy / Q000453:epidemiology* / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D007564:Japan / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D002317:Cardiovascular Agents; D007004:Hypoglycemic Agents; D007328:Insulin; C489443:zotarolimus; D020123:Sirolimus