title: Vascular effects of sirolimus-eluting versus bare-metal stents in diabetic patients: three-dimensional ultrasound results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial.
abstract: OBJECTIVE
  A predefined intravascular ultrasound (IVUS) substudy was performed to evaluate the vascular effects of sirolimus-eluting stent (SES) versus bare-metal stent (BMS).
  
  
  BACKGROUND
  The Diabetes and Sirolimus-Eluting Stent (DIABETES) trial is a prospective, multicenter, randomized, controlled trial aimed at demonstrating the efficacy of the SES compared with BMS in diabetic patients.
  
  
  METHODS
  Serial intravascular ultrasound analyses were performed in 140 lesions (SES = 75; BMS = 65) immediately after stent implantation and at nine-month follow-up. Vessel, luminal, and stent mean areas and volumes were evaluated at both edges and within the stented segment. Qualitative assessment of residual dissections and stent apposition were also performed.
  
  
  RESULTS
  Baseline clinical and angiographic characteristics were similar between groups. At 9 months, in-stent neointimal hyperplasia (NIH) mean area and volume were significantly reduced in the SES group (median NIH area 0.01 mm2 [0.0 to 0.1] vs. 2.0 mm2 [1.0 to 2.9] and median NIH volume 0.11 mm3 [0 to 2.1] vs. 35.3 mm3 [16.6 to 62.6]; both p < 0.0001). In the SES group, stent edges evidenced significant increase in lumen dimensions mainly due to significant increase in vessel volume, whereas those of the BMS group presented vessel shrinkage leading to significant lumen reduction. Late acquired incomplete stent apposition was observed in 11 lesions (14.7%) in the SES group and 0 in the BMS group (p = 0.001). At one year, no stent thromboses occurred in malapposed stents.
  
  
  CONCLUSIONS
  The SES implantation effectively inhibits NIH in diabetic patients. The antirestenotic effect of SES is also appreciated at the stent edges. Late acquired stent malapposition is a frequent phenomenon in diabetic patients treated with SES.
authors.affiliation: San Carlos University Hospital, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Jiménez-Quevedo
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.forename: Dominick J
authors.initials: DJ
authors.lastname: Angiolillo
authors.forename: Marco A
authors.initials: MA
authors.lastname: Costa
authors.forename: Fernando
authors.initials: F
authors.lastname: Alfonso
authors.forename: Joan Antoni
authors.initials: JA
authors.lastname: Gómez-Hospital
authors.forename: Rosana
authors.initials: R
authors.lastname: Hernández-Antolín
authors.forename: Camino
authors.initials: C
authors.lastname: Bañuelos
authors.forename: Javier
authors.initials: J
authors.lastname: Goicolea
authors.forename: Francisco
authors.initials: F
authors.lastname: Fernández-Avilés
authors.forename: Theodore
authors.initials: T
authors.lastname: Bass
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.forename: Raul
authors.initials: R
authors.lastname: Moreno
authors.forename: Cristina
authors.initials: C
authors.lastname: Fernández
authors.forename: Carlos
authors.initials: C
authors.lastname: Macaya
mesh_terms: D000368:Aged; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D021621:Imaging, Three-Dimensional; D008297:Male; D008670:Metals; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging; D018084:Ultrasonography, Interventional
chemical_list: D008670:Metals; D020123:Sirolimus