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

Circulation. 2004 Feb 24;109(7):861-6. doi: 10.1161/01.CIR.0000116752.12261.D4. Epub 2004 Feb 2.

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.

Methods and 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abciximab
  • Aged
  • Antibodies, Monoclonal / pharmacology
  • Antibodies, Monoclonal / therapeutic use*
  • Brazil / epidemiology
  • Cardiovascular Diseases / epidemiology
  • Cardiovascular Diseases / prevention & control
  • Coronary Angiography
  • Coronary Restenosis / diagnostic imaging
  • Coronary Restenosis / epidemiology
  • Coronary Restenosis / prevention & control*
  • Coronary Stenosis / complications
  • Coronary Stenosis / drug therapy
  • Coronary Stenosis / pathology
  • Coronary Stenosis / surgery*
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / pathology*
  • Disease-Free Survival
  • Elective Surgical Procedures
  • Female
  • Humans
  • Hyperplasia
  • Imaging, Three-Dimensional
  • Immunoglobulin Fab Fragments / pharmacology
  • Immunoglobulin Fab Fragments / therapeutic use*
  • Incidence
  • Life Tables
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / pharmacology
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control
  • Prospective Studies
  • Single-Blind Method
  • Stents*
  • Treatment Failure
  • Tunica Intima / diagnostic imaging
  • Tunica Intima / pathology*
  • Ultrasonography, Interventional / methods

Substances

  • Antibodies, Monoclonal
  • Immunoglobulin Fab Fragments
  • Platelet Aggregation Inhibitors
  • Abciximab