Low-Molecular-Weight Heparin vs. Unfractionated Heparin in Percutaneous Coronary Intervention: A Combined Analysis Maria Borentain, 1 MD, Gilles Montalescot, 1 * y MD, PhD, Anissa Bouzamondo, 2 MD, Re ´ mi Choussat, 1 MD, Jean-Se ´ bastien Hulot, 2 MD, and Philippe Lechat, 2 MD, PhD This meta-analysis assessed the rates of the efficacy and safety endpoints with intra- venous low-molecular-weight heparin (LMWH) compared with unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI). Subcutaneous LMWH has compared favorably with UFH, but limited experience exists with intrave- nous LMWH for immediate anticoagulation in PCI. The meta-analysis included data from eight randomized trials in which patients received LMWH (n = 1,037) or UFH (n = 978) during PCI. Seven additional nonrandomized studies/registries were analyzed to assess the efficacy and safety of LMWH during PCI. Efficacy endpoints were ischemic events (usually a composite of death, myocardial infarction, and urgent revasculariza- tion) and the safety endpoint was bleeding (major, minor, or all bleeding). In the randomized studies, LMWH was comparable with UFH in terms of efficacy (6.2% vs. 7.5%) and major bleeding (0.9% vs. 1.8%). The analysis of pooled data, randomized or not, suggests potential improved efficacy (5.8% vs. 7.6%) and reduced major bleeding (0.6% vs. 1.8%) with LMWH (n = 3,787) compared with UFH (n = 978). During PCI, intra- venous LMWH without coagulation monitoring has the potential to be at least as safe and efficacious as intravenous UFH. Further studies of LMWHs in PCI are therefore required. ' 2005 Wiley-Liss, Inc. Key words: anticoagulants; myocardial infarction; myocardial revascularization; treat- ment efficacy; safety INTRODUCTION The low-molecular-weight heparins (LMWHs) have been compared favorably with unfractionated heparin (UFH) for use in the routine management of patients with an acute coronary syndrome (ACS), including unstable angina (UA), non-ST segment elevation myo- cardial infarction (NSTEMI), and ST segment eleva- tion myocardial infarction (STEMI). A meta-analysis of two pivotal trials showed that antithrombotic ther- apy with enoxaparin could be considered a replace- ment for UFH in the acute phase of the management of patients with high-risk UA/NSTEMI [1]. Several other studies also suggest that LMWHs may be prom- ising alternatives to UFH as adjunctive therapy in the management of STEMI [2–10]. Despite good evidence for the therapeutic advantages of LMWHs over UFH in the medical management of patients with a high-risk ACS [1,11–13], information about the use of LMWHs in patients who undergo per- cutaneous coronary intervention (PCI) is still limited. Favorable reports of PCI in ACS patients pretreated with subcutaneous injections of enoxaparin have been published [14–17]. In elective angioplasty, several stud- ies have examined the use of intravenous LMWH in patients not previously treated by any form of anticoa- gulant. There is a widespread interest in changing the type of anticoagulant used in the catheterization labora- tory because of the limitations of UFH: unpredictable effects on coagulation, need for repeated coagulation monitoring, lack of consensus on the optimal level of anticoagulation during PCI, narrow therapeutic window, y In accordance with the policy of the Journal, the designated author discloses a financial or other interest in the subject discussed in this article. 1 Institut de Cardiologie, Pitie ´ -Salpe ˆ trie ` re University Hospital, Paris, France 2 De ´ partement de Pharmacologie, Pitie ´ -Salpe ˆ trie ` re University Hospital, Paris, France *Correspondence to: Dr. Gilles Montalescot, Institut du Cœur, Bureau 2-236, Centre Hospitalier Universitaire Pitie ´-Salpe ˆtrie `re, 47 Boulevard de l’Ho ˆpital, 75013 Paris, France. E-mail: gilles.montalescot@psl.ap-hop-paris.fr Received 9 July 2004; Revision accepted 27 January 2005 DOI 10.1002/ccd.20352 Published online 17 May 2005 in Wiley InterScience (www.interscience. wiley.com). ' 2005 Wiley-Liss, Inc. Catheterization and Cardiovascular Interventions 65:212–221 (2005)