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An Observational Study of the Relationship Between Outcome and Platelet Reactivity in Chinese Patients Undergoing PCI Loading with 600 mg clopidogrel

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Cardiovascular Innovations and Applications 2020年第3期16卷 27-35页

作者： Jing-xiu Li Ling Weng Xue-qi Li Yang Li Shu-jun Yan Zhao-yan Song Xue-yanZhang Li Cha Lin Lin Tian-shu Yang Wei-jun Lv Ying-nan Dai Ye-ping Chen De-Jun Xia Xin Li En-ze Jin Department of Cardiology The Fourth Affi liated Hospital of Harbin Medical UniversityHarbin150001 HeilongjiangChina School of Public Health of Harbin Medical University Harbin150001 HeilongjiangChina Internal Medicine Harbin Daoli Traditional Chinese Medicine HospitalHarbin150001 HeilongjiangChina

Objectives:We sought to determine whether high posttreatment platelet reactivity(HPPR)to a 600 mg loading dose of clopidogrel affects outcomes in Chinese patients with acute coronary syndrome(ACS)following percutaneous coronary intervention(PCI)and to investigate whether there is a relationship between the number of platelet reactivity units(PRUs)and the characteristics of the patients.Background:Although impaired platelet response to clopidogrel is a strong predictor of unfavorable outcome after PCI,the impact of HPPR to a 600 mg loading dose of clopidogrel in Chinese patients with ACS undergoing PCI is still unknown.Methods:We performed observational research on 134 unselected patients with ACS undergoing urgent or planned PCI with a 600 mg loading dose of clopidogrel.Platelet activation was expressed as the PRU value measured by the VerifyNow assay.Results:Among the 134 patients(mean age 60.62 years[standard deviation 9.13 years],60.4%male),there were 46 patients with HPPR(34.3%)and 88 patients without HPPR(65.7%).At a mean follow-up of 6 months(standard deviation 1 month),the rates of cardiac death,unstable angina,and rehospitalization for target lesion revascularization were higher in the HPPR group(19.6%vs.6.8%,P=0.029).Multivariate analysis identifi ed hemoglobin level and sex as independent predictors of the PRU value(y=456.355−1.736 x 1−31.880 x 2,Pclopidogrel is associated with worse outcomes after PCI.There is some relationship between the PRU value and the hemoglobin level and sex.PRU values can predict the prognosis.

关键词： clopidogrel platelet reactivity PCI VerifyNow assay high on-clopidogrel platelet reactivity

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A genome-wide association study identifies novel genetic loci that modify pharmacokinetic-pharmacodynamic responses to clopidogrel

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中国药理学与毒理学杂志 2016年第10期30卷 1047-1048页

作者： ZHONG Wan-ping WU Hong CHEN Ji-yan Li Xin-xin LIN Hao-ming ZHANG Bin ZHANG Zhi-wei MA Dun-liang SUN Shuo LI Han-ping MAI Li-ping HE Gou-dong WANG Xi-pei LEI He-ping TANG Lan LIU Shu-wen ZHONG Shi-long Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention Guangdong Cardiovascular Institute Medical Research Center of Guangdong General Hospital Guangdong Academy of Medical Sciences Sun Yatsen Memorial Hospital Sun Yat-sen University Department of Pharmaceutics School of Pharmaceutical SciencesSouthern Medical University

OBJECTIVE Genetic variants in the pharmacokinetic(PK)mechanism are the main underlying factors that modify the antiplatelet efficacy of clopidogrel.Hence,joint analysis of genetic variants that modify pharmacodynamic(PD)and PK responses to clopidogrel should be effective for identifying the genetic variants affecting the antiplatelet response to the drug.METHODS A genome-wide association study was conducted to identify new genetic loci that modify PD responses to clopidogrel and its active metabolite H4 in 115 Chinese patients with coronary heart disease(CHD).RESULTS We identified novel variants in two transporter genes(rs12456693 in SLC14A2 and rs2487032 in ABCA1)and in N6AMT1(rs2254638)associated with clopidogrel-treated P2Y12reaction unit(PRU)and plasma H4 concentration.The associations between these single nucleotide polymorphisms(SNPs)and PK parameters of clopidogrel and H4 were observed in 31 additional CHD patients(Pclopidogrel was validated in 32 liver S9 fractions,and the N6AMT1 rs2254638 T variant was found to be associated with decreased formation of H4(P=0.0386).Meanwhile,N6AMT1 rs2254638 was further identified to exert a marginal risk effect for MACE in an independent CHD patient cohort(OR:1.428,95%CI:0.978-2.086,P=0.0653,FDR=0.4726).In conclusion,we systematically identified new genetic variants as risk factors for the reduced efficacy of clopidogrel.CONCLUSION Our study findings enhanced the understanding of the absorption and metabolic mechanisms that influence PD responses to clopidogrel treatment.

关键词： clopidogrel pharmacokinetics pharmacodynamics genome-wide association study N6AMT1

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Proton pump inhibitors and gastroprotection in patients treated with antithrombotic drugs: A cardiologic point of view

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世界心脏病学杂志:英文版(电子版) 2023年第8期15卷 375-394页

作者： Maurizio Giuseppe Abrignani Alberto Lombardo Annabella Braschi Nicolo Renda Vincenzo Abrignani Operative Unit of Cardiology P.Borsellino HospitalASP TrapaniMarsala 91025TrapaniItaly Operative Unit of Cardiology S.Antonio Abate HospitalASP TrapaniErice 91100TrapaniItaly Department of Psychology Educational Science and Human MovementUniversity of PalermoPalermo 90100Italy Department of Direction CTA SalusGibellina 91024TrapaniItaly Operative Unit of Internal Medicine with Stroke Care Department of Health PromotionMother and Child CareInternal Medicine and Medical Specialties(ProMISE)“G.D’Alessandro”University of PalermoPalermo 90100Italy

Aspirin,other antiplatelet agents,and anticoagulant drugs are used across a wide spectrum of cardiovascular and cerebrovascular diseases.A concomitant proton pump inhibitor(PPI)treatment is often prescribed in these patients,as gastrointestinal complications are relatively frequent.On the other hand,a potential increased risk of cardiovascular events has been suggested in patients treated with PPIs;in particular,it has been discussed whether these drugs may reduce the cardiovascular protection of clopidogrel,due to pharmacodynamic and pharmacokinetic interactions through hepatic metabolism.Previously,the concomitant use of clopidogrel and omeprazole or esomeprazole has been discouraged.In contrast,it remains less known whether PPI use may affect the clinical efficacy of ticagrelor and prasugrel,new P2Y12 receptor antagonists.Current guidelines recommend PPI use in combination with antiplatelet treatment in patients with risk factors for gastrointestinal bleeding,including advanced age,concurrent use of anticoagulants,steroids,or non-steroidal anti-inflammatory drugs,and Helicobacter pylori(H.pylori)infection.In patients taking oral anticoagulant with risk factors for gastrointestinal bleeding,PPIs could be recommended,even if their usefulness deserves further data.H.pylori infection should always be investigated and treated in patients with a history of peptic ulcer disease(with or without complication)treated with antithrombotic drugs.The present review summarizes the current knowledge regarding the widespread combined use of platelet inhibitors,anticoagulants,and PPIs,discussing consequent clinical implications.

关键词： Antithrombotic drugs Anticoagulants Aspirin clopidogrel Gastrointestinal bleeding Proton pump inhibitors

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clopidogrel in ischemic heart disease: A critical appraisal

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Health 2013年第3期5卷 465-468页

作者： Mohammed A. Al-Otaiby Abdulrahman M. Al-Moghairi Adult Cardiology Department Prince Sultan Cardiac Center (PSCC) Riyadh Saudi Arabia Adult Cardiology Department Prince Sultan Cardiac Center (PSCC) Riyadh Saudi Arabia.

Aspirin and clopidogrel are the commonest dual antiplatelet agents being used in the secondary prevention of cardiovascular disease. In high risk patients with coronary heart disease, the use of aspirin was associated with a significant risk reduction of myocardial infarction, stroke and vascular death. The use of clopidogrel alone was slightly superior to aspirin, and associated with reduced risk of vascular death, ischemic stroke and myocardial infarction. Dual antiplatelet therapy has been well studied in patients with acute coronary syndrome and those undergoing percutaneous coronary intervention (PCI). In patients with stable coronary heart disease or multiple risk factors the combination of clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing MI, stroke or death from cardiovascular causes.

关键词： clopidogrel Ischemic Heart Disease Thienopyridine Platelets Inhibition

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Clinical relevance of clopidogrel-proton pump inhibitors interaction

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World Journal of Gastrointestinal Pharmacology and Therapeutics 2015年第2期6卷 17-21页

作者： Stella D Bouziana Konstantinos Tziomalos First Propedeutic Department of Internal Medicine Medical School Aristotle University of Thessaloniki AHEPA Hospital

clopidogrel is a widely used antiplatelet agent for the secondary prevention of cardiovascular events in patients with stable coronary heart disease, acute coronary syndromes and ischemic stroke. Even though clopidogrel is safer than aspirin in terms of risk for gastrointestinal(GI) bleeding, the elderly, and patients with a history of prior GI bleeding, with Helicobacter pylori infection or those who are also treated with aspirin, anticoagulants, corticosteroids or nonsteroidal antiinflammatory drugs are at high risk for GI complications when treated with clopidogrel. Accordingly, proton pump inhibitors are frequently administered in combination with clopidogrel to reduce the risk for GI bleeding. Nevertheless, pharmacodynamic studies suggest that omeprazole might attenuate the antiplatelet effect of clopidogrel. However, in observational studies, this interaction does not appear to translate into increased cardiovascular risk in patients treated with this combination. Moreover, in the only randomized, double-blind study that assessed the cardiovascular implications of combining clopidogrel and omeprazole, patients treated with clopidogrel/omeprazole combination had reduced risk for GI events and similar risk for cardiovascular events than patients treated with clopidogrel and placebo. However, the premature interruption of the study and the lack of power analysis in terms of the cardiovascular endpoint do not allow definite conclusions regarding the cardiovascular safety of clopidogrel/omeprazole combination. Other proton pump inhibitors do not appear to interact with clopidogrel. Nevertheless, given the limitations of existing observational and interventional studies, the decision to administer proton pump inhibitors to patients treated with clopidogrel should be individualized based on the patient's bleeding and cardiovascular risk.

关键词： clopidogrel Esomeprazole Lansoprazole Pantoprazole Rabeprazole Omeprazole Cardiovascular risk Proton pump inhibitors

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Variability of platelet aggregation in patients with clopidogrel treatment and hip fracture: A retrospective case-control study on 112 patients

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World Journal of Orthopedics 2015年第5期6卷 439-445页

作者： Anna Clareus Inga Fredriksson Hkan Wallén Max Gordon André Stark Olof Skldenberg Division of Orthopaedics Department of Clinical Sciences at Danderyd Hospital Karolinska Institutet Division of Anesthesiology Department of Clinical Sciences at Danderyd Hospital Karolinska Institutet Division of Cardiology Department of Clinical Sciences at Danderyd Hospital Karolinska Institute

AIM: To identify the rate of non-responders to clopidogrel treatment in hip fracture patients and study how non-responders differ from controls.METHODS: In a retrospective case-control study we included 28 cases of acute proximal femoral fracture with clopidogrel treatment 2011 to 2013. Eighty-four controls from the same time period were included. Data collected included response to clopidogrel measured with multiple electrode aggregometry(MEA), intraoperative bleeding, erythrocyte transfusion, time to surgery and the incidence of adverse events up to 3 mo after surgery. RESULTS: Eight(29%) of the 28 cases were nonresponders. The median intraoperative bleeding was 300 mL(range, 0-1500), and was lower for non-responders(50 m L) but did not reach statistical significance. Erythrocyte transfusions did not differ between responders, non-responders and controls. Forty-five(40%) of 112 patients had adverse events postoperatively but the rate did not differ between patients with and without clopidogrel treatment.CONCLUSION: Almost one-third of patients withclopidogrel treatment and an acute proximal femoral fracture are non-responders to antiplatelet therapy and can be operated without delay.

关键词： Proximal femoral fracture clopidogrel Variability Bleeding Adverse events

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Determination of clopidogrel Carboxylic Acid in Human Plasma by LC-MS/MS

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American Journal of Analytical Chemistry 2011年第4期2卷 447-455页

作者： Mohamed El-Husseiny El-Sadek Samia Mahmoud Moustafa Hussien Omar Kadi Abdul Moneim Ali Al-Hakami 不详

Background: clopidogrel, is a thienopyridine derivative labeled for use to prevent thrombosis after coronary artery stenting. Pharmacokinetics of clopidogrel is studied indirectly by quantification of carboxylic acid which is a major metabolite of clopidogrel. Objective: The aim of this work is to develop and validate a rapid, simple and sensitive LC/MS/MS assay method for the determination of clopidogrel carboxylic acid in human plasma using clopidogrel-D4-carboxylic acid as internal standard. Methods: Analytes was extracted from 200 μl of plasma by a simple liquid-liquid extraction using diethyl ether – n-hexane (80:20, v/v). The chromatographic separations were achieved on a C18 column using Methanol, de-ionized water and formic acid as a mobile phase at flow rate of 0.5 ml/minute. Analysis was monitored by multiple reactions monitoring mode based on m/z transition of 308.10→113 for clopidogrel carboxylic acid and 312.10→129 for internal standard. Result: The method had a total run time of about 4 minutes. The lower limit of quantification (LLOQ) was 25 ng/ml showing good linearity over the working range of 25 – 3000 ng/ml (r ≥ 0.999). The intra- and inter day accuracies were 90% - 98% and 92.138% - 96.889% respectively (deviation within acceptable range ≤ 10%).Conclusion: It was shown that this method is suitable for pharmacokinetic study following oral administration of clopidogrel and can be successfully applied to the therapeutic drug monitoring of clopidogrel in clopidogrel-treated patients.

关键词： clopidogrel clopidogrel Carboxylic Acid Liquid Chromatography Tandem Mass Spectrometry

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Prasugrel versus clopidogrel in acute coronary syndrome patients undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials

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South China Journal of Cardiology 2010年第4期11卷 238-245,249页

作者：张步春车文良刘伟静徐亚伟 Department of Cardiology Shanghai Tenth People's Hospital Tongji University School of Medicine

Background clopidogrel is beneficial after acute coronary syndrome. Recent studies suggest the superiority of prasugrel compared with clopidogrel. The enhanced platelet inhibition with prasugrel lead to a reduction in major adverse cardiovascular events in patients with moderate to high risk acute coronary syndrome scheduled for PCI. However, prasugrel showed signs of increased bleeding potential. We performed a meta-analysis to assess clinical safety and efficacy of prasugrel in patients with acute coronary syndrome. Methods We systematically searched PubMed, ISI Web of Knowledge, Cochrane Central Register of Controlled Trials, clinicaltrials. gov, proceedings of major US and European cardiology meetings, China National Knowledge Infrastructure （CNKI） databases 2000-2010 and reviews, reference lists of relevant articles. The search strategy paired the term ＂prasugrel＂＂clopidogrel＂ with the following：＂acute coronary syndrome＂＂percutaneous coronary intervention＂ We conducted a meta-analysis of randomized double-blind trials that evaluated clinical outcomes in patients with acute coronary syndrome. Two reviewers independently assessed the trials. Differences were resolved by consensus. Results A total of 2 trials with 14512 patients were available for analysis. Overall, prasugrel appeared significantly superior to clopidogrel for the risk of MACE （OR = 0.820.74-0.90, P ﹤0.0001）, stent thrombosis （OR = 0.470.35-0.62, P 0.00001）, death（OR = 0.850.78-0.93, P = 0.0003）, and myocardial infarction （OR = 0.760.68-0.85, P﹤0.00001）, without any significant difference in stroke （P = 0.85）. However, major bleeding associated with non coronary artery bypass grafting Thrombolysis in Myocardial Infarction related to prasugrel （OR = 1.321.03-1.67, P = 0.03）. Conclusions Prasugrel is superior to clopidogrel for acute coronary syndrome, while causing more bleedings.

关键词： acute coronary syndrome meta-analysis prasugrel clopidogrel

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Impact of concomitant use of proton pump inhibitors on anti-platelet therapy of clopidogrel in patients undergoing percutaneous coronary intervention

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South China Journal of Cardiology 2013年第4期14卷 219-223,236页

作者：何鹏程蒋磊马雪芬谭宁周颖玲陈纪言 Cardiology department Guangdong Academy of Medical Sciences Guangdong Provincial Cardiovascular Institute

Background In clopidogrel-treated patients undergoing percutaneous coronary intervention （PCI）, the effect of concomitant use of PPIs on prognosis remains unclear. Methods From July 2010 to June 2012, 600 patients after implantation of drug-eluting stent （DES） were assigned to 3 groups according to the medical therapy： group 1 （n = 200） received dural antiplatelet therapy （DAPT） alone （aspirine 100 mg daily plus clopidogrel 75 mg daily）, group 2（n = 199） received DAFT plus pantoprazole 20 mg daily while group 3（n = 201） received DAFT plus omeprazole 20 mg daily for 1 year. The primary outcome was major adverse cardiovascular events （MACEs） which compose of death, nonfatal myocardial infarction （MI）, nonfatal stroke, target vessel revascularization （TVR） or stent thrombosis （ST） at 1 year. Platelet reactivity was evaluated for all patients before PCI and 1 year after PCI. Results There was no significant difference in the platelet reactivity among the 3 groups at 1-year follow-up（27.3% versus 29.9% versus 29.3%, respectively, P = 0.339）. Neither was there significant difference in the incidence of 1-year MACEs （13% versus 14.6% versus 12.4%, respectively, P = 0.809）. Conclusions Concomitant use of pantoprazole or omeprazole did not influence platelet reactivity or clinical events in patients receiving DAPT after implantation of DES.

关键词： proton pump inhibitors clopidogrel drug-eluting stents

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Impact of cytochrome P450 2C19*2 polymorphism on the clinical cardiovascular events after stent implantation in patients receiving clopidogrel of a southern Tunisian region

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World Journal of Cardiovascular Diseases 2013年第1期3卷 4-10页

作者： Leila Abid Lobna Laroussi Amine Bahloul Ahmed Siala R. Abdelhédi Najla Kharrat Mourad Hentati Samir Kammoun Cardiology Department Hedi Chaker Hospital Medicine University of Sfax Sfax Tunisia CBS Center Sfax Tunisia

Introduction: The concept of clopidogrel resistance, first described in biology is being strengthened by recent data from clinical epidemiology. The cardiologists have been sensitized to this concept because of its possible involvement in the occurrence of coronary stent thrombosis. Purpose of the study: The purpose of this study was to investigate the genetic variant of the gene CYP 2C19 inour population and to assess the involvement of this genetic profile in the occurrence of major cardiovascular events (MACE) during the follow-up period. Methods: Our prospective study was conducted between May 2009 and September 2010 including 100 patients admitted to the cardiology department for percutaneous coronary stenting. The patients were divided into 2 groups: those with at least one CYP2C19*2 allele (*2 carriers) and non-carriers. Results: The mean age of our patients was 56.7 years ± 10, 5. No remarkable differences in the baseline characteristics were noted between the two groups. The prevalence of CYP2C19*2 allele in our population was 11.5%. Hospital mortality was estimated at 3%. No statistically significant differences were noted between the two groups regarding the occurrence of intra hospital MACE. The mean follow up was 7.5 ± 4.87 months for the entire study population. The rate of MACE during the follow-up of patients receiving clopidogrel was 8.2% throughout the study population: 5.3% in the *2 non-carriers versus 18.2% in the *2 carriers with a statistically significant difference (p = 0.075) at the risk of error of 10%. Concerning the occurrence of stent thrombosis, there was no significant statistical difference between the two study groups. Conclusion: From these results it is suggested that CYP2C19*2 polymorphism is associated with increase in the occurrence of MACE among Tunisian patients receiving clopidogrel. A larger study is needed to assess the role of genotyping in the evaluation of the phenomenon of clopidogrel resistance.

关键词： clopidogrel CYP2C19*2 Polymorphism MACE Stent Thrombus Percutaneous Coronary Intervention

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