Usefulness of subcutaneous low molecular weight heparin (ardeparin) for reduction of restenosis after percutaneous transluminal coronary angioplasty

Am J Cardiol. 1999 Jun 1;83(11):1524-9. doi: 10.1016/s0002-9149(99)00141-1.

Abstract

In addition to its anticoagulant effects, heparin is known to have antiproliferative effects on vascular smooth muscle cells. Ardeparin is a partially depolymerized (low molecular weight) heparin that has a longer half-life than unfractionated heparin. Following successful coronary balloon angioplasty, 565 patients were randomized to treatment with twice-daily subcutaneous ardeparin 50 anti-Xa U/kg (low dose) or 100 anti Xa U/kg body weight (high dose), or placebo for 3 months. Follow-up angiography was performed in 415 patients at 4 months, or earlier if clinically indicated. Additionally, patients underwent treadmill exercise electrocardiography at 2 weeks and 4 months. This study was designed to test the hypothesis that 3 months of subcutaneous dosing of ardeparin would reduce angiographic restenosis after coronary balloon angioplasty. Ardeparin had no effect on the incidence of angiographic restenosis (prespecified definition: > or = 50% luminal diameter narrowing plus a loss of 50% of initial gain or absolute decrease of 20% of luminal diameter). Neither the mean luminal diameters nor mean percent diameter stenoses were different among the treatment groups before, after, or 4 months after balloon angioplasty. On exercise electrocardiography at 2 weeks and 4 months, patients in all treatment groups had similar exercise tolerance, incidence of angina, and frequency of ST depression. Thus, ardeparin treatment given subcutaneously for 3 months after successful balloon angioplasty does not reduce either angiographic or clinical measures of restenosis.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Angiography
  • Angioplasty, Balloon, Coronary*
  • Antibodies / blood
  • Coronary Disease / diagnostic imaging
  • Coronary Disease / prevention & control*
  • Double-Blind Method
  • Exercise Test
  • Factor Xa / immunology*
  • Hematocrit
  • Hemorrhage / etiology
  • Heparin, Low-Molecular-Weight / administration & dosage
  • Heparin, Low-Molecular-Weight / adverse effects
  • Heparin, Low-Molecular-Weight / therapeutic use*
  • Humans
  • Injections, Subcutaneous
  • Middle Aged
  • Platelet Count
  • Treatment Outcome

Substances

  • Antibodies
  • Heparin, Low-Molecular-Weight
  • Factor Xa
  • ardeparin