ABSTRACT
BACKGROUND: Although unfractionated heparin (UFH) is an effective antithrombotic agent in endovascular interventions for the treatment of peripheral occlusive arterial disease (PAOD), it produces a highly variable anticoagulant response. Intravenous (i.v.) enoxaparin might be an effective and safe alternative. PATIENTS AND METHODS: In a prospective, open-label, randomized, single-center trial, 210 patients with PAOD (Fontaine stage IIb to IV) were randomly assigned in a 1 (UFH): 2 (enoxaparin) fashion to receive an i.v. bolus of 60 units UFH per kg body weight or 0.5 mg enoxaparin per kg body weight, respectively, before endovascular intervention. The primary composite endpoint assessed the clinical performance of enoxaparin by comparing the peri-interventional rate of thromboembolia/occlusion (efficacy) of endovascularly reconstructed areas, of bleeding according to the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) criteria (safety) and of any necessary re-intervention for any percutaneous transluminal angioplasty (PTA)-related bleeding. The secondary endpoint evaluated anti-factor (F)Xa levels during intervention. RESULTS: The primary composite endpoint showed a better performance of enoxaparin (10.5% vs. 2.5% absolute difference - 8.0%; P < 0.05). The concomitant use of acetylsalicylic acid (ASA) significantly (P < 0.05) increased the risk of a complication in the UFH group, but not in the enoxaparin group. Within 15 min, anti-Xa levels were reached by 63.7% of patients treated with enoxaparin and only by 39.1% with UFH. CONCLUSION: Enoxaparin has a better performance than UFH in endovascular interventions for the treatment of PAOD. In patients with concomitant use of ASA, the risk of complications with UFH increases significantly compared with enoxaparin.
