PMID- 21910821 OWN - NLM STAT- MEDLINE DCOM- 20120313 LR - 20230829 IS - 1538-7836 (Electronic) IS - 1538-7836 (Linking) VI - 9 IP - 11 DP - 2011 Nov TI - Comparison of enoxaparin and unfractionated heparin in endovascular interventions for the treatment of peripheral arterial occlusive disease: a randomized controlled trial. PG - 2159-67 LID - 10.1111/j.1538-7836.2011.04501.x [doi] AB - 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. CI - (c) 2011 International Society on Thrombosis and Haemostasis. FAU - Duschek, N AU - Duschek N AD - Department of Vascular and Endovascular Surgery, Wilhelminenspital, Vienna Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria. nduschek@me.com FAU - Vafaie, M AU - Vafaie M FAU - Skrinjar, E AU - Skrinjar E FAU - Hirsch, K AU - Hirsch K FAU - Waldhor, T AU - Waldhor T FAU - Hubl, W AU - Hubl W FAU - Bergmayr, W AU - Bergmayr W FAU - Knoebl, P AU - Knoebl P FAU - Assadian, A AU - Assadian A LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - J Thromb Haemost JT - Journal of thrombosis and haemostasis : JTH JID - 101170508 RN - 0 (Enoxaparin) RN - 0 (Factor Xa Inhibitors) RN - 9005-49-6 (Heparin) RN - R16CO5Y76E (Aspirin) SB - IM MH - Aged MH - Arterial Occlusive Diseases/complications/*drug therapy/surgery MH - Aspirin/therapeutic use MH - Drug Therapy, Combination/adverse effects MH - Endothelium, Vascular MH - Enoxaparin/*administration & dosage/adverse effects MH - Factor Xa Inhibitors MH - Female MH - Hemorrhage MH - Heparin/*administration & dosage/adverse effects MH - Humans MH - Male MH - Middle Aged MH - Peripheral Arterial Disease/complications/*drug therapy/surgery MH - Treatment Outcome EDAT- 2011/09/14 06:00 MHDA- 2012/03/14 06:00 CRDT- 2011/09/14 06:00 PHST- 2011/09/14 06:00 [entrez] PHST- 2011/09/14 06:00 [pubmed] PHST- 2012/03/14 06:00 [medline] AID - S1538-7836(22)07449-9 [pii] AID - 10.1111/j.1538-7836.2011.04501.x [doi] PST - ppublish SO - J Thromb Haemost. 2011 Nov;9(11):2159-67. doi: 10.1111/j.1538-7836.2011.04501.x.