title: Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial.
abstract: OBJECTIVE
  To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients.
  
  
  BACKGROUND
  Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to intimal hyperplasia (IH).
  
  
  METHODS
  In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume.
  
  
  RESULTS
  Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3) (223-482), P = 0.73] and SES [316 mm(3) (235-399) vs. 323 mm(3) (246-404), P = 0.05]) and peri-stent plaque volume: EES [163 mm(3) (103-273) vs. 184 mm(3) (115-291), P = 0.18] and SES [186 mm(3) (139-248) vs. 175 mm(3) (153-243), P = 0.26]) were unchanged in both groups. In the proximal reference segment a significant increase in plaque area was seen in the EES group only, without vascular remodeling.
  
  
  CONCLUSIONS
  In diabetic patients, EES stent implantation was associated with increased IH volume obstruction without involvement of vascular remodeling.
authors.affiliation: Department of Cardiology, Odense University Hospital, Odense, Denmark.
authors.forename: Lisbeth
authors.initials: L
authors.lastname: Antonsen
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.forename: Per
authors.initials: P
authors.lastname: Thayssen
authors.forename: Evald Høj
authors.initials: EH
authors.lastname: Christiansen
authors.forename: Knud Nørregaard
authors.initials: KN
authors.lastname: Hansen
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
authors.forename: Henrik Steen
authors.initials: HS
authors.lastname: Hansen
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Jens Flensted
authors.initials: JF
authors.lastname: Lassen
authors.forename: Lisette Okkels
authors.initials: LO
authors.lastname: Jensen
mesh_terms: D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D058426:Neointima; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D066253:Vascular Remodeling
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus; D020123:Sirolimus
keywords: AD, coronary artery disease; DIAB, diabetes; IVUS, intravascular ultrasound; PCI, percutaneous coronary intervention; STENT; stent structure