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Service de cardiologie, Hôpital universitaire nord, Marseille; FRANCE

Adjusted Clopidogrel Loading Doses According to VASP Phosphorylation Index Decrease Rate of Major Adverse Cardiovascular Events in Patients With Clopidogrel low response: A Multicentre Randomized Prospective Study. Service de cardiologie, Hôpital universitaire nord, Marseille; FRANCE

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Service de cardiologie, Hôpital universitaire nord, Marseille; FRANCE

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  1. Adjusted Clopidogrel Loading Doses According to VASP Phosphorylation Index Decrease Rate of Major Adverse Cardiovascular Events in Patients With Clopidogrel low response: A Multicentre Randomized Prospective Study. Service de cardiologie, Hôpital universitaire nord, Marseille; FRANCE Laboratoire d’hématologie, INSERM UMRS 608, Hôpital conception; Marseille; FRANCE Service de cardiologie, Hôpital d’aubagne, Aubagne; FRANCE Service de cardiologie, Clinique clairval, Marseille; FRANCE Service de cardiologie, Clinique Bouchard, Marseille; FRANCE Service de cardiologie, Hôpital privé beauregard, Marseille; FRANCE Laboratoire de statistique, Faculté de la timone, Marseille; FRANCE Service de cardiologie, Polyclinique les Fleurs, Ollioules, FRANCE L Bonello, L Camoin-Jau, S Arques, C Boyer, D Panagides, O Wittenberg, MC Siméoni, P Barragan, F Dignat-George, F Paganelli.

  2. BACKGROUND Large inter-individual variability in response to clopidogrel has been observed when a 300 mg loading dose (LD) is used. A 600 mg LD decrease the mean platelet reactivity (PR) but does not overcome the large inter-individual variability observed. In press EHJ 2008

  3. Link between low response and stent thrombosis / ischemic events

  4. VASP index P2Y12 ADP-receptor - + PGE1 PGI2 ADP AC cAMP VASP index : standardized and reproducible. Highly specificof the response to clopidogrel. PKA VASP-P VASP GP 2b/3a complex Fibrinogen binding Activated platelets Inactivated Platelets Horstrup et al. Eur J Biochem 1994;225:21-7 Geiger et al. Arterioscler Thromb Vasc Biol. 1999;19:2007-11.

  5. DEFINITION OF LOW-RESPONSE using VASP index The negative predictive value of the VASP index to predict MACE after PCI was 100% using the cut-off value of 50% of PR. Therefore we defined low response as a post- treatment platelet reactivity ≥ 50% using the VASP index in the present study. Bonello L, et al. J Thromb Haemost. 2007;5:1630-6

  6. AIM • Clinical impact of loading dose adjustment according to platelet monitoring in patients with low-response to clopidogrel.

  7. STUDY DESIGN Non-emergent PCI : ACS and Stable angina (n=406) Loading dose (LD) ASA 250mg Clopidogrel 600mg VASP ≥ 50% Randomization (n=162) CONTROL (n=84) VASP-guided LD (n=78) Up-to 3 additional LD of 600 mg every 24 hours until VASP < 50% before PCI Maintenance dose ASA 160 mg Clopidogrel 75 mg 1° endpoint: MACE (CV death, MI, revascularization) at 30 days 2° endpoints: TIMI major and minor bleeding at 30 days

  8. BASELINE CHARACTERITICS

  9. PROCEDURAL CHARACTERISTICS

  10. PLATELET MONITORING -Each additionnal bolus of 600 mg of clopidogrel decreased the number of patients with low response from 35 to 49%. -Despite 2400 mg of clopidogrel 11 (14%) patients remained low-responders.

  11. PRIMARY-END POINT : EFFICACY Log rank p =0.007 MACE: CV death, MI, revascularization † p =0.059 * p =0.007

  12. BLEEDING Using additionnal clopidogrel LD in patients with low-response and according to platelet monitoring was safe.

  13. CONCLUSION • Adjusted loading dose of clopidogrel according to platelet monitoring using VASP assay is: • Feasible, safe • Efficacious in reducing post-PCI MACE. • Reaching a post-treatment platelet reactivity <50% using the VASP index seems optimal to prevent MACE in patients.

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