Key result
INNOVANCE PFA P2Y assay shows 85% agreement with VerifyNow for assessing clopidogrel resistance in PCI.
Why the study?
VerifyNow P2Y12 is commonly used to measure clopidogrel responsiveness, but comparison with the novel INNOVANCE PFA P2Y assay in PCI patients was needed.
Does the INNOVANCE PFA P2Y assay compare favorably to the VerifyNow P2Y12 assay for assessing clopidogrel resistance in patients undergoing percutaneous coronary intervention?
Observational (n=255)
Does the INNOVANCE PFA P2Y assay compare favorably to the VerifyNow P2Y12 assay for assessing clopidogrel resistance in patients undergoing percutaneous coronary intervention?
The INNOVANCE PFA P2Y assay shows moderate correlation and comparable sensitivity to the VerifyNow P2Y12 assay for detecting clopidogrel resistance in patients undergoing PCI.
Moderate assay agreement warrants caution before clinical substitution in PCI; leaves open outcome-linked validation of platelet function tests.
INTRODUCTION: VerifyNow P2Y12 is commonly used to measure responsiveness to clopidogrel. We sought to compare the results obtained from novel INNOVANCE® PFA P2Y and VerifyNow P2Y12 assay to assess the clopidogrel resistance in patients undergoing percutaneous coronary intervention. METHODS: A total of 255 patients undergoing percutaneous coronary intervention, preliminarily treated with 100 mg/day of aspirin followed by coadministration of clopidogrel (loading dose, 600 mg; maintenance dose, 75 mg/day), were enrolled in this study. Platelet aggregation was measured by INNOVANCE® PFA P2Y and VerifyNow P2Y12. RESULTS: INNOVANCE® PFA P2Y and VerifyNow P2Y12 assay showed moderate correlations with INNOVANCE® PFA P2Y vs. VerifyNow%inhibition: r = 0.412, P < 0.0001; INNOVANCE® PFA P2Yvs.VerifyNow P2Y12 reaction units (PRU): r = -0.402, P < 0.0001. The agreement between INNOVANCE® PFA P2Y and VerifyNow%inhibition was 85% and that of INNOVANCE® PFA P2Y and VerifyNow PRU was 79%. The k statistics between INNOVANCE® PFA P2Y and VerifyNow%inhibition and PRU were 0.52 and 0.44, respectively. CONCLUSIONS: The sensitivity of INNOVANCE® PFA P2Y in detecting clopidogrel resistance is comparable to that of VerifyNow P2Y12 assay. As the PFA-100® system is already widely used, the new test cartilage may be a useful tool for the assessment of clopidogrel effects. Additional clinical correlation studies are required to validate the effectiveness of INNOVANCE® PFA P2Y in predicting long-term clinical outcomes.
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Jang et al. (2012) conducted an observational in Percutaneous coronary intervention (n=255). INNOVANCE PFA P2Y assay vs. VerifyNow P2Y12 assay was evaluated on Correlation between INNOVANCE PFA P2Y and VerifyNow %inhibition (r = 0.412, p=< 0.0001). The INNOVANCE PFA P2Y assay showed moderate correlation (r=0.412, P<0.0001) and 85% agreement with the VerifyNow P2Y12 assay for assessing clopidogrel resistance in patients undergoing PCI.
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