1. 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

2. 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

3. 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

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 <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)

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

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 ; p<0.0001
Delong & Delong diff = 0.06*
95% CI ; *p<0.0001

11. 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

12. 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

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
Discussion

14. 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

15. 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