Circulation, Vol 90, 908-914, Copyright © 1994 by American Heart Association
DP Faxon, TE Spiro, S Minor, G Cote, J Douglas, R Gottlieb, R Califf, K Dorosti, E Topol and JB Gordon
BACKGROUND: Heparin, an anticoagulant, possesses antiproliferative effects
and has been shown to reduce neointimal proliferation and restenosis
following vascular injury in experimental studies. METHODS AND RESULTS: The
primary aim of this double-blind multicenter study was to determine if 40
mg Enoxaparin, a low molecular weight heparin, administered subcutaneously
once daily for 1 month after successful angioplasty would reduce the
incidence of restenosis. Four hundred fifty-eight patients were randomized
at nine clinical centers (231 to placebo and 227 to Enoxaparin). The
primary end point was angiographic or clinical restenosis. Angiographic
restenosis was defined as a loss of 50% of the initial gain as measured by
quantitative coronary angiography (QCA) at a core laboratory. In the
absence of QCA, clinical evidence of restenosis was defined as death,
myocardial infarction, repeat revascularization, or worsening angina. Using
the intention-to- treat analysis for all patients, restenosis occurred in
51% of the placebo group and 52% of the Enoxaparin group (relative risk,
1.07, P = .625). Likewise, no difference in restenosis was evident when the
change in minimal lumen diameter or other angiographic definitions of
restenosis were used. Adverse clinical events were infrequent and did not
differ between the groups with the exception of minor bleeding
complications, which were more common in the Enoxaparin group. CONCLUSIONS:
Enoxaparin (40 mg/d SC for 1 month) following successful angioplasty did
not reduce the incidence of angiographic restenosis or the occurrence of
clinical events over 6 months. The treatment was well tolerated, although
in-hospital minor bleeding was more common with active treatment.
ARTICLES
Low molecular weight heparin in prevention of restenosis after angioplasty. Results of Enoxaparin Restenosis (ERA) Trial
Evans Memorial Department of Medicine, Boston University Medical Center, Mass.
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