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      Relationship between Cytochrome P450 2C19 *2 Polymorphism and Stent Thrombosis following Percutaneous Coronary Intervention in Chinese Patients Receiving Clopidogrel

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          Abstract

          This study investigated the relationship between the cytochrome P450 2C19 (CYP2C19) *2 polymorphism (681A) and definite stent thrombosis (ST) in patients undergoing percutaneous coronary intervention (PCI) and receiving clopidogrel (75 mg/day, orally). The CYP2C19 *2 polymorphism status of 1738 Chinese patients with coronary artery disease was examined. The primary endpoint was the occurrence of definite ST during the 180-day follow-up period. The presence of at least one CYP2C19 *2 allele was significantly associated with increased ST risk (19 CYP2C19 *2/ *2 or *1/ *2 patients [2.4%] versus seven homozygous wild-type CYP2C19 *1/ *1 patients [0.75%]). The risk of definite ST was highest in patients with the CYP2C19 *2/ *2 genotype. The CYP2C19 *2 genotype is associated with an increased risk of definite ST following coronary stent placement among Chinese patients with coronary artery disease receiving clopidogrel.

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          Clinical end points in coronary stent trials: a case for standardized definitions.

          Donald E Cutlip, Stephan Windecker, Roxana Mehran … (2007)
          Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
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            Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction.

            Ilya Novikov, Roy Bienart, Boris S. Shenkman … (2004)
            Although clopidogrel reduces the risk of cardiovascular episodes after coronary events and stenting, a substantial number of incidents continue to occur. The antiplatelet effect of clopidogrel was studied prospectively in 60 consecutive patients who underwent primary angioplasty (percutaneous coronary intervention [PCI]) with stenting for acute ST-segment-elevation myocardial infarction (STEMI) to determine whether variability in response to clopidogrel affects clinical outcomes. Patients were stratified into 4 quartiles according to the percentage reduction of ADP-induced platelet aggregation. Although patients in the first quartile were resistant to the effects of clopidogrel (ADP-induced platelet aggregation at day 6, 103+/-8% of baseline), ADP-induced aggregation was reduced to 69+/-3%, 58+/-7%, and 33+/-12% of baseline, respectively, in patients in quartiles 2 through 4 (P<0.01 for all). In addition, epinephrine-induced platelet aggregation and platelet aggregation under flow conditions, assessed by the cone-and-plate(let) analyzer method, were reduced significantly less in the first quartile than in quartiles 2 through 4. Whereas 40% of patients in the first quartile sustained a recurrent cardiovascular event during a 6-month follow-up, only 1 patient (6.7%) in the second quartile and none in the third and fourth quartiles suffered a cardiovascular event (P=0.007). Up to 25% of STEMI patients undergoing primary PCI with stenting are resistant to clopidogrel and therefore may be at increased risk for recurrent cardiovascular events.
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              Cytochrome P450 2C19 loss-of-function polymorphism is a major determinant of clopidogrel responsiveness in healthy subjects.

              Jean-Sébastien Hulot, Alessandra Bura, Eric Villard … (2006)
              The capacity of clopidogrel to inhibit ADP-induced platelet aggregation shows wide intersubject variability. To determine whether frequent functional variants of genes coding for candidate cytochrome P450 (CYP) isoenzymes involved in clopidogrel metabolic activation (CYP2C19*2, CYP2B6*5, CYP1A2*1F, and CYP3A5*3 variants) influence the platelet responsiveness to clopidogrel, we conducted a prospective pharmacogenetic study in 28 healthy white male volunteers treated for 7 days with clopidogrel 75 mg/d. We observed that pharmacodynamic response to clopidogrel was significantly associated with the CYP2C19 genotype. Twenty of the subjects were wild-type CYP2C19 (*1/*1) homozygotes, while the other 8 subjects were heterozygous for the loss-of-function polymorphism CYP2C19*2 (*1/*2). Baseline platelet activity was not influenced by the CYP2C19 genotype. In contrast, platelet aggregation in the presence of 10 muM ADP decreased gradually during treatment with clopidogrel 75 mg once daily in *1/*1 subjects, reaching 48.9% +/- 14.9% on day 7 (P < .001 vs baseline), whereas it did not change in *1/*2 subjects (71.8% +/- 14.6% on day 7, P = .22 vs baseline, and P < .003 vs *1/*1 subjects). Similar results were found with VASP phosphorylation. The CYP2C19*2 loss-of-function allele is associated with a marked decrease in platelet responsiveness to clopidogrel in young healthy male volunteers and may therefore be an important genetic contributor to clopidogrel resistance in the clinical setting.
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                Author and article information

                Journal
                Title: Journal of International Medical Research
                Abbreviated Title: J Int Med Res
                Publisher: SAGE Publications
                ISSN (Print): 0300-0605
                ISSN (Electronic): 1473-2300
                Publication date Created: October 2011
                Publication date (Electronic): October 01 2011
                Publication date (Print): October 2011
                Volume: 39
                Issue: 5
                Pages: 2012-2019
                Affiliations
                [1 ] Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China
                [2 ] Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
                [3 ] Department of Cardiology, People's Hospital of Pu-dong New Area, Shanghai, China
                Article
                DOI: 10.1177/147323001103900548
                SO-VID: d3fbe255-420e-4a37-aad3-78bebd20e5c4
                Copyright © © 2011
                License:

                http://journals.sagepub.com/page/policies/text-and-data-mining-license

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                ScienceOpen disciplines: Genetics
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                ScienceOpen disciplines: Genetics

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