title: Usefulness of subcutaneous low molecular weight heparin (ardeparin) for reduction of restenosis after percutaneous transluminal coronary angioplasty.
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.
authors.affiliation: Cardiovascular Division, University of Virginia Health Science Center, Charlottesville 22908, USA. lgimple@virginia.edu
authors.forename: L W
authors.initials: LW
authors.lastname: Gimple
authors.forename: H C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: M
authors.initials: M
authors.lastname: Winniford
authors.forename: E
authors.initials: E
authors.lastname: Mammen
mesh_terms: D000328:Adult; D000368:Aged; D000792:Angiography; D015906:Angioplasty, Balloon, Coronary; D000906:Antibodies / Q000097:blood; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000517:prevention & control*; D004311:Double-Blind Method; D005080:Exercise Test; D015951:Factor Xa / Q000276:immunology*; D006400:Hematocrit; D006470:Hemorrhage / Q000209:etiology; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D008875:Middle Aged; D010976:Platelet Count; D016896:Treatment Outcome
chemical_list: D000906:Antibodies; D006495:Heparin, Low-Molecular-Weight; D015951:Factor Xa; C093450:ardeparin