1 / 15

Enoxaparin Anticoagulation Monitoring in the Cath- Lab Using a New Bedside Assay

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.

sandra_john
Download Presentation

Enoxaparin Anticoagulation Monitoring in the Cath- Lab Using a New Bedside Assay

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Enoxaparin Anticoagulation Monitoring in the Cath- LabUsing 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

  2. 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

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

  4. 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.

  5. A new bedside test HEMONOXTM assay 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)

  6. Enoxaparin Protocol

  7. 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

  8. Patients characteristics

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

  10. 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

  11. 83% Accuracy (95% CI 80-86) 94.9% Se (95% CI 91-97) 73.3% Spe (95% Cl 68-79) Hemonox CT >120 sec Detection of AntiXa <0.5 IU/mL AntiXa ≥0.5 IU/mL AntiXa <0.5 IU/mL

  12. MACCE * n=13 (4.5%) at 30 days Death n=3 (1.0%) * Death + MI + uTVR + Stroke Clinical Outcomes and Safety 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

  13. 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

  14. 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. Conclusion (1/2) 1- Hemonox CT is an easy to usebedside test able to rapidly monitor enoxaparin anticoagulation in patients undergoing PCI 4- The test can be seen as a tool for tailored enoxaparin therapy in the cath-lab

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

More Related