Impact of anticoagulation levels on outcomes in patients undergoing elective percutaneous coronary intervention: insights from the STEEPLE trial
1 Institut de Cardiologie (AP-HP) and INSERM Unit no. 856, Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France
2 Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ, USA
3 sanofi-aventis, Paris, France
4 UZ Gasthuisberg, Leuven, Belgium
5 Servicio de Cardiología, Hospital Universitario, Madrid, Spain
6 Cardiology Department, Flinders Medical Centre, Adelaide, SA, Australia
7 Service de Cardiologie, Hôpital Bichat, Paris, France
8 Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
9 Montreal Heart Institute, Université de Montréal, Montréal, Canada
10 Division of Cardiology, University of Kentucky, Lexington, KY, USA
Received 4 May 2007; revised 18 December 2007; accepted 8 January 2008.
* Corresponding author. Tel: +33 1 42 16 30 06, Fax: +33 1 42 16 29 31, Email: gilles.montalescot{at}psl.aphp.fr or gilles.montalescot{at}psl.ap-hop-paris.fr
Aims: To determine the relationship between anticoagulation levels during percutaneous coronary intervention, and ischaemic events and bleeding.
Methods and results: A sub-analysis from the STEEPLE trial was conducted. Pre-defined target anticoagulation levels were achieved in 86% of patients receiving enoxaparin, compared with 20% receiving unfractionated heparin (UFH) (P < 0.001). A significant relationship was observed between anti-Xa levels > 0.9 IU/mL and covariate-adjusted rate of non-coronary artery bypass graft-related major and minor bleeding [odds ratio (OR) 1.6, 95% CI 1.0–2.5 for each unit of anti-Xa; P = 0.03]; anti-Xa levels and covariate-adjusted incidence of death, myocardial infarction, or revascularization showed no significance (P = 0.47). Major bleeding increased significantly with an activated clotting time (ACT) > 325 s (OR 1.6, 95% CI 1.1–2.2 per 100 s; P = 0.04). A significant relationship with increasing ischaemic events was observed when ACT was < 325 s (OR 0.7, 95% CI 0.2–0.8 per 100 s; P = 0.006) indicating a narrow therapeutic window.
Conclusion: Target anticoagulation levels were achieved more readily in patients receiving enoxaparin. An anti-Xa level of up to 0.9 IU/mL has a good safety and efficacy profile; poor achievement of target ACT with UFH makes assessing the optimal range difficult.
Key Words: Anticoagulation • Enoxaparin • Percutaneous coronary intervention • Unfractionated heparin
This paper was guest edited by Freek W.A. Verheugt, Department of Cardiology, Heartcenter, University Medical Center Nijmegen, PO Box 9101, Nijmegen 6500 HB, The Netherlands.