Platelet responsiveness to clopidogrel treatment after peripheral endovascular procedures: the PRECLOP study: clinical impact and optimal cutoff value of on-treatment high platelet reactivity
Stavros Spiliopoulos, Georgios Pastromas, Konstantinos Katsanos, Panagiotis Kitrou, Dimitrios Karnabatidis, Dimitrios Siablis, Stavros Spiliopoulos, Georgios Pastromas, Konstantinos Katsanos, Panagiotis Kitrou, Dimitrios Karnabatidis, Dimitrios Siablis
Abstract
Objectives: This study aimed to assess the clinical implications and optimal cutoff value of high platelet reactivity (HPR) in patients receiving clopidogrel for peripheral endovascular procedures.
Background: As noted in coronary studies, HPR could be related to increased adverse events.
Methods: This prospective trial included patients receiving clopidogrel 75 mg daily, before and after infrainguinal angioplasty or stenting. Platelet inhibition was assessed with the VerifyNow P2Y12 point-of-care test. Primary endpoints were 1-year clinical events rate (composite endpoint of death, major stroke, major amputation, target vessel revascularization, and bypass) according to the P2Y12 reaction units (PRU)-based quartile distribution, the estimation of the optimal PRU cutoff value for predicting clinical outcome, and the identification of independent predictors influencing event-free survival.
Results: In total, 100 consecutive patients were enrolled. The 1-year cumulative events rate was 4% in the first quartile, 12% in the second, 52% in the third, and 84% in the fourth. Pairwise comparisons demonstrated a significant difference in the composite endpoint between successive quartiles (all p < 0.05 except for the first vs. second quartile). According to receiver-operating characteristic curve analysis, the optimal cutoff value for the composite endpoint was PRU ≥234 (area under the curve: 0.883; 95% confidence interval [CI]: 0.811 to 0.954; p < 0.0001; sensitivity: 92.1%; specificity: 84.2%). Cox multivariate regression analysis identified HPR (PRU ≥234) as the only independent predictor of an increased number of adverse events (hazard ratio: 16.9; 95% CI: 5 to 55; p < 0.0001).
Conclusions: On-treatment HPR is associated with markedly increased adverse clinical events in patients undergoing peripheral endovascular procedures. Point-of-care clopidogrel assessment might be useful in individualizing antiplatelet therapy to attain superior clinical results. (High On-Treatment Platelet Reactivity Following Peripheral Endovascular Procedures [PRECLOP]; NCT01744613).
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed