title: A 10-month angiographic and 4-year clinical outcome of everolimus-eluting versus sirolimus-eluting coronary stents in patients with diabetes mellitus (the DiabeDES IV randomized angiography trial).
abstract: OBJECTIVE
  We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.
  
  
  BACKGROUND
  There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.
  
  
  METHODS
  We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.
  
  
  RESULTS
  At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).
  
  
  CONCLUSIONS
  EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
authors: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors: Michael
authors: M
authors: Maeng
authors: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.|Department of Cardiology, Center of Cardiology and Angiology, Vilnius University Hospital, Vilnius, Lithuania.
authors: Arvydas
authors: A
authors: Baranauskas
authors: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors: Evald Høj
authors: EH
authors: Christiansen
authors: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors: Anne
authors: A
authors: Kaltoft
authors: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors: Niels Ramsing
authors: NR
authors: Holm
authors: Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.
authors: Lars Romer
authors: LR
authors: Krusell
authors: Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark.
authors: Jan
authors: J
authors: Ravkilde
authors: Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark.
authors: Hans-Henrik
authors: HH
authors: Tilsted
authors: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors: Per
authors: P
authors: Thayssen
authors: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors: Lisette Okkels
authors: LO
authors: Jensen
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000401:mortality; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000401:mortality; D003718:Denmark; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000401:mortality; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus
keywords: coronary; drug-eluting; everolimus; randomized clinical trial; sirolimus; stent