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J Am Coll Cardiol, 2008; 51:1925-1934, doi:10.1016/j.jacc.2007.12.056
© 2008 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Cytochrome P450 2C19 681G>A Polymorphism and High On-Clopidogrel Platelet Reactivity Associated With Adverse 1-Year Clinical Outcome of Elective Percutaneous Coronary Intervention With Drug-Eluting or Bare-Metal Stents

Dietmar Trenk, PhD*,*, Willibald Hochholzer, MD*, Martin F. Fromm, MD{dagger}, Ligia-Emilia Chialda, MD{dagger}, Andreas Pahl, PhD{dagger}, Christian M. Valina, MD*, Christian Stratz, MD*, Peter Schmiebusch, MD*, Hans-Peter Bestehorn, MD*, Heinz Joachim Büttner, MD* and Franz-Josef Neumann, MD*

* Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany
{dagger} Institute of Experimental and Clinical Pharmacology and Toxicology, University of Erlangen-Nuremberg, Erlangen, Germany.

Manuscript received September 10, 2007; revised manuscript received November 30, 2007, accepted December 10, 2007.

* Reprint requests and correspondence: Dr. Dietmar Trenk, Herz-Zentrum Bad Krozingen, Suedring 15, D-79189 Bad Krozingen, Germany. (Email: dietmar.trenk{at}herzzentrum.de).

Objectives: We investigated whether the loss of function CYP2C19 681G>A *2 polymorphism is associated with high (>14%) residual platelet aggregation (RPA) on clopidogrel and whether high on-clopidogrel RPA impacts clinical outcome after elective coronary stent placement.

Background: The cytochrome P450 (CYP)–dependent conversion of clopidogrel to its active metabolite may contribute to the variability in antiplatelet effect of clopidogrel.

Methods: The study included 797 consecutive patients undergoing percutaneous coronary intervention, who were followed-up for 1 year. Adenosine-diphosphate–induced (5 µmol/l) RPA was assessed after a 600-mg loading dose and after the first 75-mg maintenance dose of clopidogrel before discharge. CYP2C19 genotype was analyzed by real-time polymerase chain reaction.

Results: Of the patients included, 552 (69.3%) were CYP2C19 wild-type homozygotes (*1/*1) and 245 (30.7%) carried at least one *2 allele. Residual platelet aggregation at baseline did not differ significantly between genotypes. On clopidogrel, RPA was significantly (p < 0.001) higher in *2 carriers than in wild-type homozygotes (23.0% [interquartile range (IQR) 8.0% to 38.0%] vs. 11.0% [IQR 3.0% to 28.0%] after loading; 11.0% [IQR 5.0% to 22.0%] vs. 7.0% [IQR 3.0% to 14.0%] at pre-discharge). Between *2 carriers and wild-type homozygotes, we found significant (p < 0.001) differences in the proportion of patients with RPA >14%, both after loading (62.4% vs. 43.4%) and at pre-discharge (41.3% vs. 22.5%). Residual platelet aggregation >14% at pre-discharge incurred a 3.0-fold increase (95% confidence interval 1.4 to 6.8; p = 0.004) in the 1-year incidence of death and myocardial infarction.

Conclusions: Patients carrying at least one CYP2C19*2 allele are more prone to high-on clopidogrel platelet reactivity, which is associated with poor clinical outcome after coronary stent placement (Effect of Clopidogrel Loading and Risk of PCI [EXCELSIOR]; NCT00457236 [ClinicalTrials.gov] ).

Abbreviations and Acronyms
  ADP = adenosine diphosphate
  CI = confidence interval
  CYP = cytochrome P450
  GP = glycoprotein
  MI = myocardial infarction
  PCI = percutaneous coronary intervention
  PCR = polymerase chain reaction
  RPA = residual platelet aggregation


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Association of Cytochrome P450 2C19 Genotype With the Antiplatelet Effect and Clinical Efficacy of Clopidogrel Therapy
JAMA, August 26, 2009; 302(8): 849 - 857.
[Abstract] [Full Text] [PDF]

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 JAMAHome page
D. L. Bhatt
Tailoring Antiplatelet Therapy Based on Pharmacogenomics: How Well Do the Data Fit?
JAMA, August 26, 2009; 302(8): 896 - 897.
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 Eur Heart JHome page
C. Verstuyft, T. Simon, and R. B. Kim
Personalized medicine and antiplatelet therapy: ready for prime time?
Eur. Heart J., August 2, 2009; 30(16): 1943 - 1963.
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 Eur Heart JHome page
C. Varenhorst, S. James, D. Erlinge, J. T. Brandt, O. O. Braun, M. Man, A. Siegbahn, J. Walker, L. Wallentin, K. J. Winters, et al.
Genetic variation of CYP2C19 affects both pharmacokinetic and pharmacodynamic responses to clopidogrel but not prasugrel in aspirin-treated patients with coronary artery disease
Eur. Heart J., July 2, 2009; 30(14): 1744 - 1752.
[Abstract] [Full Text] [PDF]

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 The Annals of PharmacotherapyHome page
N. B Norgard, K. D Mathews, and G. C Wall
Drug-Drug Interaction Between Clopidogrel and the Proton Pump Inhibitors
Ann. Pharmacother., July 1, 2009; 43(7): 1266 - 1274.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The Year in Interventional Cardiology
J. Am. Coll. Cardiol., June 2, 2009; 53(22): 2080 - 2097.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
C. M. Barker and H. V. Anderson
Acute Coronary Syndromes: Don't Bypass the Clopidogrel
J. Am. Coll. Cardiol., May 26, 2009; 53(21): 1973 - 1974.
[Full Text] [PDF]

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 CirculationHome page
M. J. Price
Bedside Evaluation of Thienopyridine Antiplatelet Therapy
Circulation, May 19, 2009; 119(19): 2625 - 2632.
[Full Text] [PDF]

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 CirculationHome page
J. L. Mega, S. L. Close, S. D. Wiviott, L. Shen, R. D. Hockett, J. T. Brandt, J. R. Walker, E. M. Antman, W. L. Macias, E. Braunwald, et al.
Cytochrome P450 Genetic Polymorphisms and the Response to Prasugrel: Relationship to Pharmacokinetic, Pharmacodynamic, and Clinical Outcomes
Circulation, May 19, 2009; 119(19): 2553 - 2560.
[Abstract] [Full Text] [PDF]

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 J Clin PharmacolHome page
N. F. Ford
Clopidogrel Resistance: Pharmacokinetic or Pharmacogenetic?
J. Clin. Pharmacol., May 1, 2009; 49(5): 506 - 512.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
D. Sibbing, J. Stegherr, W. Latz, W. Koch, J. Mehilli, K. Dorrler, T. Morath, A. Schomig, A. Kastrati, and N. von Beckerath
Cytochrome P450 2C19 loss-of-function polymorphism and stent thrombosis following percutaneous coronary intervention
Eur. Heart J., April 2, 2009; 30(8): 916 - 922.
[Abstract] [Full Text] [PDF]

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 Arterioscler. Thromb. Vasc. Bio.Home page
S. S. Smyth, D. S. Woulfe, J. I. Weitz, C. Gachet, P. B. Conley, S. G. Goodman, M. T. Roe, A. Kuliopulos, D. J. Moliterno, P. A. French, et al.
G-Protein-Coupled Receptors as Signaling Targets for Antiplatelet Therapy
Arterioscler Thromb Vasc Biol, April 1, 2009; 29(4): 449 - 457.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
L. Ang and E. Mahmud
Reply
J. Am. Coll. Cardiol., March 10, 2009; 53(10): 901 - 901.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
A. N. DeMaria, O. Ben-Yehuda, J. J. Bax, G. K. Feld, B. H. Greenberg, W. Y.W. Lew, J. A.C. Lima, A. S. Maisel, S. M. Narayan, D. J. Sahn, et al.
Highlights of the Year in JACC 2008
J. Am. Coll. Cardiol., January 27, 2009; 53(4): 373 - 398.
[Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
P. Gladding, M. Webster, I. Zeng, H. Farrell, J. Stewart, P. Ruygrok, J. Ormiston, S. El-Jack, G. Armstrong, P. Kay, et al.
The Pharmacogenetics and Pharmacodynamics of Clopidogrel Response: An Analysis From the PRINC (Plavix Response in Coronary Intervention) Trial
J. Am. Coll. Cardiol. Intv., December 1, 2008; 1(6): 620 - 627.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
N. S. Kleiman
Searching for the Ceiling: New Reflections on the Disposition and Metabolism of Clopidogrel
J. Am. Coll. Cardiol. Intv., December 1, 2008; 1(6): 628 - 630.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
D. L. Bhatt, J. Scheiman, N. S. Abraham, E. M. Antman, F. K.L. Chan, C. D. Furberg, D. A. Johnson, K. W. Mahaffey, E. M. Quigley, R. A. Harrington, et al.
ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents
J. Am. Coll. Cardiol., October 28, 2008; 52(18): 1502 - 1517.
[Full Text] [PDF]

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 CirculationHome page
Writing Committee Members, D. L. Bhatt, J. Scheiman, N. S. Abraham, E. M. Antman, F. K. L. Chan, C. D. Furberg, D. A. Johnson, K. W. Mahaffey, and E. M. Quigley
ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents
Circulation, October 28, 2008; 118(18): 1894 - 1909.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
J. A. Cairns and J. Eikelboom
Clopidogrel Resistance: More Grist for the Mill
J. Am. Coll. Cardiol., May 20, 2008; 51(20): 1935 - 1937.
[Full Text] [PDF]


 
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