CLINICAL STUDY
A unique, low dose of intravenous enoxaparin in elective percutaneous coronary intervention
R.émi Choussat, MD*,
Gilles Montalescot, MD, PhD*,*,
Jean Philippe Collet, MD, PhD*,
Eric Vicaut, MD, PhD ,
Annick Ankri, MD ,
Vanessa Gallois, BSc*,
G.érard Drobinski, MD, PhD*,
Ivan Sotirov, MD* and
Daniel Thomas, MD*
* Department of Cardiology, Paris, France
Hemostasis Laboratory, Pitié-Salpêtrière Hospital, Paris, France
Laboratory of Biophysics, Fernand-Widal Hospital, Paris, France
Manuscript received March 28, 2002;
revised manuscript received June 6, 2002,
accepted June 24, 2002.
* Reprint requests and correspondence: Dr. Gilles Montalescot, Institut du Coeur, Bureau 2-236, Centre Hospitalier Universitaire Pitié-Salpêtrière, 47 Boulevard de l’Hôpital, 75013 Paris, France.
gilles.montalescot{at}psl.ap-hop-paris.fr
OBJECTIVES: This study was designed to examine a unique and low dose of intravenous enoxaparin in elective percutaneous coronary intervention (PCI) that would be applicable to an unselected population regardless of age, weight, renal function, or use of glycoprotein IIb/IIIa inhibitors.
BACKGROUND: There is limited experience of anticoagulation using intravenous (IV) low-molecular-weight heparin in PCI, which has been obtained with high doses causing elevated anticoagulation levels and delayed sheath withdrawal.
METHODS: A total of 242 consecutive patients undergoing elective PCI were treated with a single IV bolus of enoxaparin (0.5 mg/kg), and 26% of patients (n = 64) also received eptifibatide. Sheaths were removed immediately after the procedure in patients treated with enoxaparin only, and 4 h after the procedure in those also treated with eptifibatide.
RESULTS: A peak anti-Xa >0.5 IU/ml was obtained in 97.5% of the population, and 94.6% of patients had their peak anti-Xa level in the predefined target range of 0.5 to 1.5 IU/ml. Advanced age, renal failure, being overweight, and eptifibatide use did not alter the anticoagulation profile. At one-month follow-up, six patients (2.5%) had died, had a myocardial infarction, or undergone an urgent revascularization; all the patients had an anti-Xa level >0.5 IU/ml during PCI. Patients without an ischemic event and without a creatine kinase rise, but with a detectable troponin release in the next 24 h of PCI (>2 µg/ml, n = 21), had similar anti-Xa levels as those without troponin elevation. There were one major and three minor bleeding events that were not associated with anti-Xa overshoot.
CONCLUSIONS: Low-dose (0.5 mg/kg) IV enoxaparin allows a prespecified target level of anticoagulation (anti-Xa >0.5 IU/ml) in the vast majority of patients undergoing PCI, appears to be safe and effective, allows immediate sheath removal when used alone, and does not require dose adjustment when used with eptifibatide.
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Abbreviations and Acronyms
| | ACT | | activated clotting time | | aPTT | | activated partial thromboplastin time | | CI | | confidence interval | | CK | | creatine kinase | | ECG | | electrocardiogram | | GP | | glycoprotein | | IV | | intravenous | | LMWH | | low-molecular-weight heparin | | MI | | myocardial infarction | | NICE | | National Investigators Collaborating on Enoxaparin | | NSTEMI | | non–ST-elevation myocardial infarction | | PCI | | percutaneous coronary intervention | | PEPCI | | Pharmacokinetic study of Enoxaparin in Patients undergoing Coronary Intervention | | TIMI | | Thrombolysis In Myocardial Infarction | | UA | | unstable angina | | UFH | | unfractionated heparin |
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