Comparison of enoxaparin and unfractionated heparin in endovascular interventions for the treatment of peripheral arterial occlusive disease: a randomized controlled trial

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