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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Point-of-Care Measurement of Clopidogrel Responsiveness Predicts Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention

Results of the ARMYDA-PRO (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty-Platelet Reactivity Predicts Outcome) Study

Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy

Manuscript received March 25, 2008; revised manuscript received June 5, 2008, accepted June 9, 2008.

^_* Reprint requests and correspondence: Prof. Germano Di Sciascio, Department of Cardiovascular Sciences, Campus Bio-Medico University, Via Alvaro del Portillo, 200, 00128 Rome, Italy (Email: g.disciascio{at}unicampus.it).

Objectives: The aim of this study was to evaluate the correlation of point-of-care measurement of platelet inhibition with clinical outcome in patients undergoing percutaneous coronary intervention (PCI).

Background: Individual variability of clopidogrel response might influence results of PCI.

Methods: A total of 160 patients receiving clopidogrel before PCI were prospectively enrolled. Platelet reactivity was measured by the VerifyNow P2Y12 assay (Accumetrics Inc., San Diego, California). Primary end point was 30-day occurrence of major adverse cardiac events (MACE) according to quartile distribution of P2Y12 reaction units (PRU).

Results: Primary end point occurred more frequently in patients with pre-procedural PRU levels in the fourth quartile versus those in the lowest quartile (20% vs. 3%; p = 0.034), and it was entirely due to periprocedural myocardial infarction (MI). Mean PRU absolute levels were higher in patients with periprocedural MI (258 ± 53 vs. 219 ± 69 in patients without; p = 0.030). On multivariable analysis pre-PCI PRU levels in the fourth quartile were associated with 6-fold increased risk of 30-day MACE (odds ratio: 6.1; 95% confidence interval: 1.1 to 18.3, p = 0.033). By receiver-operating characteristic curve analysis, the optimal cut-off for the primary end point was a pre-PCI PRU value 240 (area under the curve: 0.69; 95% confidence interval: 0.56 to 0.81, p = 0.016).

Conclusions: This study indicates that high pre-PCI platelet reactivity might predict 30-day events. Use of a rapid point-of-care assay for monitoring residual platelet reactivity after clopidogrel administration might help identify patients in whom individualized antiplatelet strategies might be indicated with coronary intervention.

Key Words: clopidogrel • percutaneous coronary intervention • platelet aggregometry

Abbreviations and Acronyms   ACS = acute coronary syndromes   ADP = adenosine diphosphate   CK-MB = creatine kinase-myocardial band   LTA = light transmittance aggregometry   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PRU = platelet (P2Y12) reaction units   ROC = receiver-operating characteristic   Tn = troponin

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