Usefulness of the INNOVANCE® PFA P2Y test cartridge for the detection of patients with congenital defects of the platelet P2Y12 receptor for adenosine diphosphate

INTRODUCTION: The platelet function analyzer (PFA)-100® is used in clinical practice to screen patients with bleeding diathesis and suspected defects of primary hemostasis. A new cartridge, INNOVANCE® PFA P2Y, has been specifically developed to monitor patients' response to drugs inhibiting the platelet P2Y12 receptor for ADP. In this study, we compared the ability of INNOVANCE® PFA P2Y to detect congenital defects of the platelet P2Y12 receptor to that of standard cartridge formulations currently in clinical use. MATERIALS AND METHODS: We studied two patients with severe P2Y12 deficiency, one patient with heterozygous P2Y12 deficiency and one with dysfunctional P2Y12 receptor. Closure times were measured using 3 cartridges: collagen/ADP, collagen/epinephrine, and INNOVANCE® PFA P2Y. The results obtained in the four patients with P2Y12 defects were compared to those obtained for 20 healthy controls. RESULTS: In 2 patients with severe P2Y12 deficiency, closure times of INNOVANCE® PFA P2Y and collagen/ADP cartridges were >300s, while those of collagen/epinephrine cartridge were variable (186s and >300s). In the patient with dysfunctional P2Y12, closure time of INNOVANCE® PFA P2Y was >300s, while closure times of collagen/ADP and collagen/epinephrine were normal. Closure times of all cartridges were normal in the patient with heterozygous P2Y12 deficiency. CONCLUSION: Our study provides the first evidence that INNOVANCE® PFA P2Y cartridge is sensitive to congenital severe and moderate defects of the platelet P2Y12 receptors.