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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Enoxaparin Anticoagulation Monitoring in the Catheterization Laboratory Using a New Bedside Test

Johanne Silvain, MD^_*, Farzin Beygui, MD, PhD^_*, Annick Ankri, MD, Anne Bellemain-Appaix, MD^_*, Ana Pena, PhD^_*, Olivier Barthelemy, MD^_*, Guillaume Cayla, MD^_*, Vanessa Gallois, BS^_*, Sophie Galier, BS^_*, Dominique Costagliola, PhD, Jean-Philippe Collet, MD, PhD^_* and Gilles Montalescot, MD, PhD^_*,_*

^_* Institut de Cardiologie, Institut National de la Santé et de la Recherche Médicale (INSERM) CMR937, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France
Institut de Cardiologie, INSERM U720, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France
Service d'Hématologie Biologique, Pitié-Salpêtrière Hospital (AP-HP), Université Paris 6, Paris, France

Manuscript received June 23, 2009; revised manuscript received August 27, 2009, accepted August 30, 2009.

^_* Reprint requests and correspondence: Dr. Gilles Montalescot, Bureau 256, Institut de Cardiologie, Pitié-Salpêtrière Hospital, 47-83 Boulevard de l'Hôpital, Paris 75013, France (Email: gilles.montalescot{at}psl.aphp.fr).

Objectives: This study evaluated the ability of the bedside test Hemochron Jr. Hemonox (International Technidyne Corporation, Edison, New Jersey) to identify patients with insufficient anti-Xa activity level in the catheterization laboratory.

Background: Inadequate anticoagulation in patients undergoing percutaneous coronary intervention (PCI) is associated with increased periprocedural ischemic events.

Methods: In 296 unselected patients undergoing catheterization and/or PCI, whole blood Hemonox clotting time (CT) and activated partial thromboplastin time (aPTT) were measured at baseline (T1) and 10 min after the intravenous administration of enoxaparin (T2) in patients receiving additional enoxaparin and compared with plasma chromogenic anti-Xa activity level.

Results: Median values were 0.1 IU/ml (interquartile range [IQR]: 0.1 to 0.1 IU/ml) and 0.87 IU/ml (IQR: 0.74 to 1.03 IU/ml) for anti-Xa; 74 s (IQR: 70 to 81 s) and 143 s (IQR: 114 to 206 s) for Hemonox CT; and 44 s (IQR: 39 to 50 s) and 72 s (IQR: 58 to 93 s) for aPTT at T1 and T2, respectively. When using Hemonox CT to discriminate patients with anti-Xa level <0.5 IU/ml, the area under the receiver operating characteristic curve was 0.95 ± 0.01 (95% confidence interval [CI]: 0.93 to 0.97) versus 0.89 ± 0.01 (95% CI: 0.86 to 0.92) for aPTT. The threshold value of 120 s was associated with a 94.9% (95% CI: 91.1% to 97.4%) sensitivity and a 73.3% (95% CI: 67.6% to 78.5%) specificity to detect patients with inadequate anti-Xa level (<0.5 IU/ml) and positive predictive and negative predictive values of 73.9% (95% CI: 68.7% to 79.0%) and 94.78% (95% CI: 91.8% to 97.8%), respectively.

Conclusions: Hemonox CT appears to be a fast and reliable bedside test for detecting patients insufficiently anticoagulated and needing adjustment of anticoagulation therapy with enoxaparin before PCI.

Key Words: enoxaparin • bedside test • percutaneous coronary intervention

Abbreviations and Acronyms   ACS = acute coronary syndrome   aPTT = activated partial thromboplastin time   CI = confidence interval   CT = clotting time   IQR = interquartile range   IV = intravenous   LMWH = low molecular weight heparin   MACCE = major cardiovascular and cerebrovascular events   PCI = percutaneous coronary intervention   ROC = receiver-operating characteristic   SQ = subcutaneous   STEMI = ST-segment elevation myocardial infarction   UFH = unfractionated heparin

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