title: Volumetric analysis of in-stent intimal hyperplasia in diabetic patients treated with or without abciximab: results of the Diabetes Abciximab steNT Evaluation (DANTE) randomized trial.
abstract: BACKGROUND
  In diabetic patients in the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT) trial, abciximab reduced target vessel revascularization by approximately 50% compared with placebo. Whether this is a result of a lower restenosis rate caused by inhibition of intimal hyperplasia remains to be defined.
  
  
  RESULTS
  The purpose of this study was to determine whether abciximab at the time of stent implantation would reduce in-stent intimal hyperplasia measured by intravascular ultrasound at 6-month follow-up in type 2 diabetics. Ninety-six diabetic patients (96 lesions) who underwent elective stent implantation for a de novo lesion in a native coronary artery were randomly assigned to receive abciximab or no abciximab. In-stent intimal hyperplasia volume, expressed as percentage of stent volume, did not differ between groups: 41.3+/-21.0% for those treated with abciximab versus 40.5+/-18.3% for those treated without abciximab (P=0.9). There were also no significant differences in angiographic minimal luminal diameter at follow-up (1.74+/-0.69 versus 1.66+/-0.63 mm; P=0.5), late loss (1.03+/-0.63 versus 1.07+/-0.58 mm; P=0.7), restenosis rate (17.8% versus 22.9%; P=0.5), or cumulative incidence of major adverse cardiac events at 12 months (19.1% versus 20.4%; P=0.9).
  
  
  CONCLUSIONS
  Six-month intravascular ultrasound volumetric analysis showed that abciximab, at the time of coronary stent implantation, was not associated with a reduction of in-stent intimal hyperplasia in diabetic patients.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Aurea J
authors.initials: AJ
authors.lastname: Chaves
authors.forename: Amanda G M R
authors.initials: AG
authors.lastname: Sousa
authors.forename: Luiz A
authors.initials: LA
authors.lastname: Mattos
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Staico
authors.forename: Fausto
authors.initials: F
authors.lastname: Feres
authors.forename: Marinella
authors.initials: M
authors.lastname: Centemero
authors.forename: Luiz F
authors.initials: LF
authors.lastname: Tanajura
authors.forename: Andrea
authors.initials: A
authors.lastname: Abizaid
authors.forename: Ibraim
authors.initials: I
authors.lastname: Pinto
authors.forename: Galo
authors.initials: G
authors.lastname: Maldonado
authors.forename: Ana
authors.initials: A
authors.lastname: Seixas
authors.forename: Marco A
authors.initials: MA
authors.lastname: Costa
authors.forename: Angela
authors.initials: A
authors.lastname: Paes
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: J Eduardo
authors.initials: JE
authors.lastname: Sousa
mesh_terms: D000077284:Abciximab; D000368:Aged; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D001938:Brazil / Q000453:epidemiology; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000150:complications / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000473:pathology*; D018572:Disease-Free Survival; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D006965:Hyperplasia; D021621:Imaging, Three-Dimensional; D007140:Immunoglobulin Fab Fragments / Q000494:pharmacology / Q000627:therapeutic use*; D015994:Incidence; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D016037:Single-Blind Method; D015607:Stents; D017211:Treatment Failure; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000473:pathology*; D018084:Ultrasonography, Interventional / Q000379:methods
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab