Enoxaparin Anticoagulation Monitoring in the Cath- Lab Using a New Bedside Assay Johanne Silvain, Farzin Beygui, Annick Ankri, Anne Bellemain-Appaix, Ana Pena, Olivier Barthelemy, Guillaume Cayla, Vanessa Gallois, Sophie Galier, Dominique Costagliola, Jean-Philippe Collet, Gilles Montalescot Silvain J et al . JACC 2010; 55:617

Dr Silvain Disclosure = Research Grant Funding - Disclosures Funding of the study This study was supported in part by INSERM (Institut National de la Santé et de la Recherche Médicale) and by International Technidyne Corporation (ITC) Edison, NJ, U.S.A. Dr Silvain Disclosure = Research Grant BMS, Daiichi-Sankyo, Eli Lilly, Sanofi-Aventis

Enoxaparin in guidelines ESC 2008 ACC/AHA 2007 STEEPLE 0.5mg IV bolus META-ANALYSIS (Dumaine et al) Elective PCI Ø Ø Non-ST ACS IIa-B I-A Invasive (urgent/early) 1mg/kg/12H SC Conservative I-A I-B STEMI ATOLL ? 0.5mg IV bolus Primary PCI Ø Ø I-B after enoxaprin I-A IIa-B (sk) I-A Fibrinolysis

Aim of the study to evaluate the ability of the Hemonox assay to identify in the cath-lab patients with insufficient enoxaparin anticoagulation before PCI = low anti-Xa activity level <0.5 IU/mL measured by chromogenic reference technique Patients at High Risk of ischemic complications Montalescot G. Circulation 2004;110:392-8.

A new bedside test HEMONOXTM assay <25 μl of whole blood per test International Technidyne Corporation (ITC), NJ, US El Rouby S. J Thromb Thrombolysis (2006) 21: 137–145 <25 μl of whole blood per test HEMONOX Clotting Time (seconds)

Enoxaparin Protocol

Flow chart 313 patients entered the study 11 patients did not received any enoxaparin 6 patients were on oral anticoagulant (vit-K antagonist) 296 patients went through analysis 211 patients = IV ENOX 64 patients = SQ ENOX 21 patients = SQ + IV ENOX 14 patients = treatment unknown 9 patients were lost on Fup 287 patients had a complete Fup

Patients characteristics

The distribution of anti-Xa levels 1.8 optimal anticoagulation in 95% of patients Median Anti-Xa Level T1 = 0.1 IU/mL [0.1-0.1] T2 = 0.87 IU/mL [0.74-1.03] 0.5 4.7 % Patients at High Risk of ischemic complications ! 9

Evaluation of the Hemonox CT AUC Hemonox CT : 0.95 ±0.01 95% Cl 0.93–0.97; p<0.0001 AUC aPTT : 0.89 ±0.01 95% Cl 0.86-0.92; p<0.0001 Delong & Delong diff = 0.06* 95% CI 0.03-0.09; *p<0.0001

Detection of AntiXa <0.5 IU/mL 94.9% Se (95% CI 91-97) 73.3% Spe (95% Cl 68-79) 83% Accuracy (95% CI 80-86) Hemonox CT >120 sec AntiXa <0.5 IU/mL AntiXa ≥0.5 IU/mL

Clinical Outcomes and Safety MACCE * n=13 (4.5%) at 30 days Death n=3 (1.0%) * Death + MI + uTVR + Stroke Bleeding rate = 2 major bleedings (0.66%) ( both anti-Xa level <1.2 IU/ml) p=0.9 157 p=0.3 139 0.87 0.76

Limitations 1- not powered to assess the impact of the Hemonox CT on clinical outcomes 2- Limited information obtained on high levels of anticoagulation as very few patients (n=3) reached anti-Xa values > 1.8 IU/ml 3- the cost-effectiveness of a monitoring guided strategy of enoxaparin anticoagulation has not been evaluated Discussion

Conclusion (1/2) 1- Hemonox CT is an easy to use bedside test able to rapidly monitor enoxaparin anticoagulation in patients undergoing PCI 2- High risk patients (anti-Xa activity <0.5 IU/ml) can be reliably identified Montalescot G. Circulation 2004;110:392-8. 3- Hemonox CT can ensure that an adequate anticoagulation level is present before PCI and avoid stacking and overdosing with UFH Ferguson JJ. SYNERGY trial. JAMA 2004;292:45-54. 4- The test can be seen as a tool for tailored enoxaparin therapy in the cath-lab

How to use Hemonox test in cath-lab ? Conclusion (2/2) How to use Hemonox test in cath-lab ? Patients is well anticoagulated Right in 94.8% PCI 120 sec Patients is under anticoagulated Right in 73.3% additional IV bolus of 0.5 mg/kg enoxaparin