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Clinical validation of AggreGuide A-100 ADP, a novel assay for assessing the antiplatelet effect of oral P2Y12 antagonists

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Abstract

In this prospective, 3-arm, repeated-measure multicenter investigation in 280 patients with cardiovascular risk factors, platelet aggregation was measured with the novel AggreGuide A-100 ADP (A-100 ADP) and VerifyNow (VN)-PRU assays at baseline, and after United States Food and Drug Administration approved loading and 7 days maintenance doses of clopidogrel (n = 94), prasugrel (n = 43) or ticagrelor, (n = 143). Based on the predetermined cutoff values of < 4.7 platelet activity index with A-100 ADP assay to indicate antiplatelet response, more than 91% of patients met the criteria following loading and maintenance doses of prasugrel and more than 84% patients met the criteria following loading and maintenance doses of ticagrelor whereas only 32% and 51% of patients met the criteria following loading and maintenance doses of clopidogrel, respectively. The total percent agreement between the A-100 ADP and VN-PRU assays was 89%. The A-100 ADP assay, which includes whole blood in motion, performs comparably to the VN-PRU assay in a study of patients with cardiovascular risk factors treated with P2Y12 inhibitors possessing known differences in antiplatelet potencies.

Trial registration ClinicalTrials.gov Identifier: NCT3111420.

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Funding

This study was funded by Aggredyne, Inc, Houston, TX, USA.

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Authors and Affiliations

  1. Sinai Center for Thrombosis Research and Drug Development, Sinai Hospital of Baltimore, Baltimore, MD, 21215, USA

    Paul A. Gurbel, Udaya S. Tantry & Kevin P. Bliden

  2. Aggredyne, Inc, Houston, TX, USA

    Richard Fisher

  3. Thrombodyne Inc, Salt Lake City, UT, USA

    Sivaprasad Sukavaneshvar

  4. Hikari Dx, San Diego, CA, USA

    Jeffrey Dahlen

  5. PCS Houston LLC, Houston, TX, USA

    Philip C. Speros

Authors
  1. Paul A. Gurbel
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  2. Udaya S. Tantry
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  3. Kevin P. Bliden
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  4. Richard Fisher
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  5. Sivaprasad Sukavaneshvar
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  6. Jeffrey Dahlen
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  7. Philip C. Speros
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Contributions

PG, KPB, RF, SS, JD, and PCS were involved in the study design; RF, SS, and PCS were involved in funding; KPB, UT, SS, JD, RF, and PCS were involved in data collection and interpretation; UST, SS, PG, KPB, PCS, and JD were involved in manuscript writing and critical evaluation of the manuscript. All the authors read and approved the final version of the manuscript.

Corresponding author

Correspondence to Paul A. Gurbel.

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Conflicts of interest

Dr. Gurbel reports grants and personal fees from Bayer HealthCare LLC, Otitopic Inc, Amgen, Janssen, and US WorldMeds LLC; grants from Instrumentation Laboratory, Haemonetics, Medicure Inc, Idorsia Pharmaceuticals, and Hikari Dx; personal fees from UpToDate; Dr Gurbel is a relator and expert witness in litigation involving clopidogrel; in addition, Dr. Gurbel has two patents: Detection of restenosis risk in patients and Assessment of cardiac health and thrombotic risk in a patient. Dr. Tantry reports personal fees from UptoDate and Aggredyne. Richard Fisher is an employee of Aggredyne; Philip C Speros was an employee of Aggredyne and is an employee of PCS Houston; Sivaprasad Sukavaneshvar is an employee of Thrombodyne Inc. and Jeff Dahlen is an employee of Hikari Dx.

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Gurbel, P.A., Tantry, U.S., Bliden, K.P. et al. Clinical validation of AggreGuide A-100 ADP, a novel assay for assessing the antiplatelet effect of oral P2Y12 antagonists. J Thromb Thrombolysis 52, 272–280 (2021). https://doi.org/10.1007/s11239-021-02498-0

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  • DOI: https://doi.org/10.1007/s11239-021-02498-0

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