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

摘要: Summary. 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 and safe alternative. Patients methods: In prospective, open-label, randomized, single-center trial, 210 patients with PAOD (Fontaine stage IIb to IV) were randomly assigned 1 (UFH): 2 (enoxaparin) fashion receive i.v. bolus 60 units UFH per kg body weight or 0.5 mg weight, respectively, before intervention. The primary composite endpoint assessed clinical performance by comparing peri-interventional rate thromboembolia/occlusion (efficacy) endovascularly reconstructed areas, bleeding according Global Utilization Streptokinase t-PA Occluded Coronary Arteries (GUSTO) criteria (safety) any necessary re-intervention percutaneous transluminal angioplasty (PTA)-related bleeding. secondary evaluated anti-factor (F)Xa levels during Results: The showed better (10.5% vs. 2.5% absolute difference – 8.0%; P < 0.05). concomitant use acetylsalicylic acid (ASA) significantly (P < 0.05) increased risk complication group, but not group. Within 15 min, anti-Xa reached 63.7% treated only 39.1% UFH. Conclusion: Enoxaparin has than PAOD. In ASA, complications increases compared enoxaparin.