CLINICAL RESEARCH: ANTIPLATELET THERAPY
Variability in platelet responsiveness to clopidogrel among 544 individuals
Victor L. Serebruany, MD, PhD*,*,
Steven R. Steinhubl, MD, FACC ,
Peter B. Berger, MD, FACC ,
Alex I. Malinin, MD*,
Deepak L. Bhatt, MD, FACC and
Eric J. Topol, MD, FACC
* HeartDrug Research Laboratories, Towson, Maryland
University of Kentucky, Lexington, Kentucky
Duke Clinical Research Institute, Durham, North Carolina
Cleveland Clinic, Cleveland, Ohio
Manuscript received July 7, 2004;
revised manuscript received September 22, 2004,
accepted September 27, 2004.
* Reprint requests and correspondence: Dr. Victor L. Serebruany, HeartDrug Research Laboratories, Osler Medical Building, 7600 Osler Drive, Suite 307, Towson, Maryland 21204 (Email: heartdrug{at}aol.com).
OBJECTIVES: We sought to describe the responses of patients to clopidogrel using ex vivo measures of platelet aggregation and activation in a large, heterogeneous population.
BACKGROUND: Recently, a number of reports, using various definitions, have dichotomized patients who are treated with clopidogrel into a minority of "non-responders" and a majority of "responders." Such classifications imply that treatment leads to an all-or-none response, with potentially important clinical implications.
METHODS: We conducted secondary post-hoc analyses of a dataset consisting of volunteers (n = 94) and patients after coronary stenting (n = 405), with heart failure (n = 25), and after stroke (n = 20).
RESULTS: The response of subjects to clopidogrel followed a normal, bell-shaped distribution, with a mean and standard deviation of 41.9 ± 20.8% when aggregation was induced by 5 µmol/l of adenosine diphosphate. When hyporesponsiveness and hyper-responsiveness to clopidogrel were considered to be two standard deviations less than and greater than the mean, respectively, the prevalence of hyporesponsiveness and hyper-responsiveness in these patients was 4.2% and 4.8%, respectively. Pretreatment platelet activity and clinical characteristics were not associated with responsiveness to clopidogrel.
CONCLUSIONS: Individuals receiving clopidogrel exhibit a wide variability in response that follows a normal distribution. The clinical implications of this variability are unknown but potentially are important. Clinical trials are needed to define whether hyporesponders to clopidogrel are at increased risk for thrombotic events and whether hyper-responders are at increased risk for bleeding. If so, the individualization of antiplatelet therapy, including clopidogrel dosing, may be possible in the future but will require the ability to easily and reproducibly measure responsiveness by a method that has been proven to be predictive of clinical events.
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Abbreviations and Acronyms
| | ADP = adenosine diphosphate | | PRP = platelet-rich plasma |
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1715 - 1722.
[Abstract]
[Full Text]
[PDF]
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V L Serebruany, M G Midei, H Meilman, A I Malinin, and D R Lowry
Platelet inhibition with prasugrel (CS-747) compared with clopidogrel in patients undergoing coronary stenting: the subset from the JUMBO study.
Postgrad. Med. J.,
June 1, 2006;
82(968):
404 - 410.
[Abstract]
[Full Text]
[PDF]
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S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol.,
April 18, 2006;
47(8):
1689 - 1706.
[Full Text]
[PDF]
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S. A. de Oliveira, L. H. W. Gowdak, G. Buckberg, J. E. Krieger, and the RESTORE Group
Cell biology, MRI and geometry: insight into a microscopic/macroscopic marriage
Eur. J. Cardiothorac. Surg.,
April 1, 2006;
29(Suppl_1):
S259 - S265.
[Abstract]
[Full Text]
[PDF]
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E. D. Michos, R. Ardehali, R. S. Blumenthal, R. A. Lange, and H. Ardehali
Aspirin and Clopidogrel Resistance
Mayo Clin. Proc.,
April 1, 2006;
81(4):
518 - 526.
[Abstract]
[Full Text]
[PDF]
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T. H. Wang, D. L. Bhatt, and E. J. Topol
Aspirin and clopidogrel resistance: an emerging clinical entity
Eur. Heart J.,
March 2, 2006;
27(6):
647 - 654.
[Abstract]
[Full Text]
[PDF]
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A. A. Barsky and R. R. Arora
Clopidogrel Resistance: Myth or Reality?
Journal of Cardiovascular Pharmacology and Therapeutics,
March 1, 2006;
11(1):
47 - 53.
[Abstract]
[PDF]
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E. I. Lev, R. T. Patel, K. J. Maresh, S. Guthikonda, J. Granada, T. DeLao, P. F. Bray, and N. S. Kleiman
Aspirin and Clopidogrel Drug Response in Patients Undergoing Percutaneous Coronary Intervention: The Role of Dual Drug Resistance
J. Am. Coll. Cardiol.,
January 3, 2006;
47(1):
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[Abstract]
[Full Text]
[PDF]
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E. I. Lev, R. T. Patel, K. J. Maresh, S. Guthikonda, J. Granada, T. DeLao, P. F. Bray, and N. S. Kleiman
Aspirin and Clopidogrel Drug Response in Patients Undergoing Percutaneous Coronary Intervention: The Role of Dual Drug Resistance
J. Am. Coll. Cardiol.,
December 13, 2005;
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[Abstract]
[Full Text]
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B. Labarthe, P. Theroux, M. Angioi, and M. Ghitescu
Matching the Evaluation of the Clinical Efficacy of Clopidogrel to Platelet Function Tests Relevant to the Biological Properties of the Drug
J. Am. Coll. Cardiol.,
August 16, 2005;
46(4):
638 - 645.
[Abstract]
[Full Text]
[PDF]
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N. Jochmann, K. Stangl, E. Garbe, G. Baumann, and V. Stangl
Female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases
Eur. Heart J.,
August 2, 2005;
26(16):
1585 - 1595.
[Abstract]
[Full Text]
[PDF]
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S. R. Steinhubl, R. Charnigo, and D. J. Moliterno
Resistance to Antiplatelet Resistance: Is it Justified?
J. Am. Coll. Cardiol.,
June 7, 2005;
45(11):
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E. R. Bates, W. C. Lau, and B. E. Bleske
Loading, Pretreatment, and Interindividual Variability Issues With Clopidogrel Dosing
Circulation,
May 24, 2005;
111(20):
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T. A. Nguyen, J. G. Diodati, and C. Pharand
Resistance to clopidogrel: A review of the evidence
J. Am. Coll. Cardiol.,
April 19, 2005;
45(8):
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[Abstract]
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