Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel following endovascular therapy of peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.
Study Type
OBSERVATIONAL
Enrollment
100
Patras University Hospital
Rio, Achaia, Greece
Major event-free survival
12 months freedom from all causes of death, stroke, index limb amputation, non pre-scheduled minor amputation, index limb bypass surgery and target vessel recanalization (TVR)stratified according to PRU values distribution
Time frame: 12 months
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition
Optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition measured with VerifyNow P2Y12 assay point-of-care testing, influencing the 12 months primary outcome of major event-free survival estimated by ROC analysis
Time frame: 12 months
Positive and negative predictive value of PRU testing
Positive and negative predictive value of PRU measurement with regard to the primary outcome of major event-free survival
Time frame: 12 months
Bleeding rate
12-months bleeding rate including intracranial hemorrhage and puncture related pseudoaneurysm stratified according to PRU values
Time frame: 12 months
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