751-4 Low Molecular Weight Heparin in the Prevention of Restenosis After Coronary Angioplasty. Results of the FACT Study

Abstract

Restenosis after coronary angioplasty is a multifactorial process that may involve elastic recoil, thrombus incorporation, smooth muscle cell proliferation, and late vascular remodeling. Fraxiparine (nadroparin) is a low molecular weight heparin derivative that has potent antithrombotic and antiproliferative properties in animal models. The FACT (Fraxiparine Angioplastie Coronaire Transluminale) study is a multicentre double-blind randomised trial designed to compare the effects of treatment with Fraxiparine or aspirin on the occurrence of restenosis after coronary balloon angioplasty. All patients received aspirin (250 mg, daily) before coronary angioplasty. Therapeutic doses of unfractionated heparin were used during coronary angioplasty in both groups. The active treatment group received subcutaneous injections of Fraxiparine (0.6 ml) daily for 3 days before coronary angioplasty that was continued for 3 months. The control group was treated with aspirin (250 mg) daily for 3 months. In total, 354 patients were randomized and constitute the intention-to-treat population. Angiographic follow-up was performed in 91% of patients with successful procedures at 3 months. There were no differences between groups in baseline clinical characteristics. The acute gain (0.96 ± 0.42 mm, 1.03 ± 0.40 mm) and late loss (0.36 ± 0.51 mm, 0.36 ± 0.57 mm) were similar in the Fraxiparine and aspirin groups. Restenosis, defined as a binary variable (stenosis >50% at angiographic follow-up) occurred in 41% of the Fraxiparine treated and 38% of the aspirin treated group (p = 0.69). At six months major clinical event rates, death (1% vs 2%), acute myocardial infarction (4% vs 2%) and repeat revascularization (26% vs 26%) were similar in both groups. Despite, 3 days of pretreatment and 3 months of treatment with low molecular weight heparin (Fraxiparine), no statistical differences were observed in angiographic or clinical end points.