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• W1997996874 abstract "HomeCirculationVol. 131, No. 12Selection of a Suitable Patient Population for New Antiplatelet Therapy From the Large Clinical Trial Database of the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events–Thrombolysis in Myocardial Infarction 50 (TRA-2P–TIMI50) Trial Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBSelection of a Suitable Patient Population for New Antiplatelet Therapy From the Large Clinical Trial Database of the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events–Thrombolysis in Myocardial Infarction 50 (TRA-2P–TIMI50) Trial Shinichi Goto, MD and Shinya Goto, MD, PhD Shinichi GotoShinichi Goto From Department of Medicine (Cardiology), Tokai University School of Medicine, Kanagawa, Japan. Search for more papers by this author and Shinya GotoShinya Goto From Department of Medicine (Cardiology), Tokai University School of Medicine, Kanagawa, Japan. Search for more papers by this author Originally published13 Feb 2015https://doi.org/10.1161/CIRCULATIONAHA.115.015471Circulation. 2015;131:1041–1043Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: March 24, 2015: Previous Version 1 In this issue of Circulation, Cavender et al1 present an interesting report on the prevention of cardiovascular (CV) events in patients with previous myocardial infarction (MI) with and without diabetes mellitus (DM) by using vorapaxar, a new class of antiplatelet agent of thrombin receptor (protease-activated receptor-1) antagonists.1,2 Platelet cells are known to play crucial roles in both hemostasis and pathological thrombus formation.3 The efficacy and safety of various antiplatelet agents have been tested in many clinical settings, including acute coronary syndrome,4,5 cerebrovascular, coronary, and peripheral arterial diseases,6 stable outpatients with atherothrombosis,7 and so on. The complicated and yet to be clarified quantitative relationship between the activation and inhibition of each receptor on platelet cells (as shown in the Figure)8–10 and the onset of thrombotic and bleeding events makes it difficult to predict the most suitable antiplatelet intervention in individual patients with the use of a constructive logic.11 Thus, the evidence-based approach is currently the only available tool to test scientific hypotheses in clinical medicine. Similar to the other antiplatelet agents, the efficacy and safety of vorapaxar were tested initially in relatively broad patient populations such as acute coronary syndrome12 and secondary prevention cohorts.13 Early termination of the trial, for the subpopulations of patients12,14 who were expected to gain no benefit with the use of the drug in comparison with the expected harm of serious bleeding, worked well for the clinical development of vorapaxar. In this issue of Circulation, Cavender et al1 give us a further clue to the select subpopulation of patients who receive greater benefit from this drug, which is patients with previous MI and DM.Download figureDownload PowerPointFigure. Role of the platelet cell for hemostasis and thrombus formation. There are several important activation receptors on a platelet cell as shown on the lower right. GP Ibα is essentially important for initial platelet adhesion on a damaged vessel, especially under high-shear flow conditions. Once platelet cells are activated, thromboxane (Tx)-A2 production and the release of ADP from dense granules occurs. These locally released vasoactive substances stimulate platelet Tx-A2 receptor and ADP receptors of P2Y1 and P2Y12. These receptors are the target of the widely used antiplatelet agents aspirin and clopidogrel and the new generation of P2Y12 inhibitors prasugrel and ticagrelor. It is noteworthy that activated platelet cells locally regulate the coagulant cascade as shown (Top). The prothrombinase complex formed on the surface of activated platelet cells, which provide negatively charged phospholipids, efficiently catalyzes prothrombin to thrombin as shown in the center. Thrombin formed on the surface of activated platelet cells stimulates PAR-1 for further activation of platelets. Vorapaxar prevents thrombotic events by blocking PAR-1, but the quantitative relationship between PAR-1 inhibition for platelet activation in comparison with Tx-A2/P2Y12 inhibition in DM and non-DM patients is still unknown. ADP indicates Adenosine 5-Diphosphate; DM, diabetes mellitus; GP, glycoprotein; PAR-1, protease-activated receptor-1; P2Y12, adenosine 5′-diphosphate receptor; and TXA2, thromboxane-A2.Article see p 1047Still High CV Event Rates in Patients With Previous MI and DMIt is noteworthy that the CV event rate of 14.3%/3 years in patients with both prior MI and DM under current standard of care, including antiplatelet therapy, is substantially high in comparison with that of patients with previous MI without DM, which is 7.6%/3 years.1 The high CV event rate in patients both with previous MI and DM was observed even when almost all patients were on aspirin, and three-fourths of the patients were on thienopyridine at least at baseline. The use of lipid-lowering agents and angiotensin-converting enzyme/angiotensin II receptor blockers in these patients is also high in comparison with the patients recruited in the previous registry.15 Thus, the high event rate in patients with both previous MI and DM demonstrated in this trial is not a result of the underuse of evidence-proven drugs, but suggests that currently available preventive therapy in these patient populations has inadequate power. Although vorapaxar reduces the CV event rate to 11.4%/3 years, this event rate is still higher than that of patients with previous MI without DM.Platelet Cell Is Still Too Complicated to Understand Its Functions for the Onset of Thrombotic and Bleeding EventsAlthough the mechanism is unknown, several reports have suggested fewer antiplatelet effects with the widely used antiplatelet agents aspirin and clopidogrel in patients with DM.16,17 The results Cavender et al reported in this issue of Circulation suggest a potential reason for the high CV event rate in patients with both previous MI and DM, that is, increased activation of platelets in these patients even receiving aspirin/P2Y12 inhibitor therapy. It is speculation, but the activation of platelets even under aspirin and P2Y12 inhibitors may be attributable at least in part to increased interaction with the von Willebrand factor expressed on endothelial cells in the microcirculation in DM patients and the increased activation of platelets through glycoprotein Ibα receptor stimulation by the von Willebrand factor.18 Indeed, even in basic research, both aspirin and P2Y12 receptor antagonists are not strong enough to inhibit platelet activation and aggregation mediated by von Willebrand factor interaction with glycoprotein Ibα8,19 The current report by Cavender et al supports the idea that the impaired effects of currently available antiplatelet therapy on platelet activation may explain the reason for the high CV event rate in patients with previous MI with DM. Further quantitative understanding of the mechanism and the role of platelet cells and the effects of currently available antiplatelet agents for the onset and prevention of thrombotic CV events in DM patients are awaited.Evidence-Based Selection of Subpopulation of Patients Who Get the Most Benefit From A Large Clinical Trial DatabaseFinally, Cavender et al convincingly show that the results of the same antiplatelet intervention are not homogenous in DM and non-DM patients. In the era when CV event risk is low in general, the way that Cavender et al demonstrated in the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events–Thrombolysis in Myocardial Infarction 50 (TRA-2P–TIMI50) trial is suggestive for future directions. Initially, the efficacy and safety of vorapaxar was tested in broad secondary prevention cohort.13 A small part of the trial population not expecting benefits, such as the cerebrovascular disease arm, was stopped early during the trial.14 Of the patients with previous MI who benefitted from this intervention,20 Cavender et al demonstrated a further small population who would get more benefit, that is the DM and previous MI patients.1 Provided that it is still difficult to predict the efficacy of antiplatelet intervention in individual patients constructively, selection of a specific patient population that gains real benefit from the intervention by using a approach similar to what Cavender et al demonstrated, which is to accumulate a huge database in clinical trials, test clinical hypotheses in this patient population, then conduct subanalysis to find the most suitable patient populations, should still be helpful.DisclosuresDr Shinya Goto received a Grant-in-Aid for Scientific Research in Japan (24390202) and grants for the Strategic Program for Innovational Research Field 1 for Super-computational Life Science. He received consulting fees and honoraria from Eisai, Sanofi-Aventis, Otsuka, Bayer HealthCare, Novartis, Astra-Zeneca, Astellas, Pfizer, Medtronics-Japan, Mitsubishi-Tanabe Pharma, Takeda, Daiichi-Sankyo, Mochida and MSD. He also received research grants from Sanofi-Aventis, Eisai, Boehringer Ingelheim, Otsuka and Daiichi-Sankyo. Dr Shinichi Goto reports no conflicts.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Shinya Goto, MD, PhD, Department of Medicine (Cardiology), Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan. E-mail [email protected]References1. Cavender MA, Scirica BM, Bonaca MP, Angiolillo DJ, Dalby AJ, Dellborg M, Morais J, Murphy SA, Oude Ophuis T, Tendera M, Braunwald E, Morrow DA.Vorapaxar in patients with diabetes mellitus and previous myocardial infarction: findings from the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events-TIMI 50 trial.Circulation. 2015; 131:1047–1053. DOI: 10.1161/CIRCULATIONAHA.114.013774.LinkGoogle Scholar2. Angiolillo DJ, Capodanno D, Goto S.Platelet thrombin receptor antagonism and atherothrombosis.Eur Heart J. 2010; 31:17–28. doi: 10.1093/eurheartj/ehp504.CrossrefMedlineGoogle Scholar3. Angiolillo DJ, Ueno M, Goto S.Basic principles of platelet biology and clinical implications.Circ J. 2010; 74:597–607.CrossrefMedlineGoogle Scholar4. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation.N Engl J Med. 2001; 345:494–502. doi: 10.1056/NEJMoa010746.CrossrefMedlineGoogle Scholar5. Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA, Freij A, Thorsén M; PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes.N Engl J Med. 2009; 361:1045–1057. doi: 10.1056/NEJMoa0904327.CrossrefMedlineGoogle Scholar6. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee.Lancet. 1996; 348:1329–1339.CrossrefMedlineGoogle Scholar7. Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events.N Engl J Med. 2006; 354:1706–1717. doi: 10.1056/NEJMoa060989.CrossrefMedlineGoogle Scholar8. Goto S, Tamura N, Eto K, Ikeda Y, Handa S.Functional significance of adenosine 5′-diphosphate receptor (P2Y12) in platelet activation initiated by binding of von Willebrand factor to platelet GP Ibalpha induced by conditions of high shear rate.Circulation. 2002; 105:2531–2536.LinkGoogle Scholar9. Goto S, Ikeda Y, Saldívar E, Ruggeri ZM.Distinct mechanisms of platelet aggregation as a consequence of different shearing flow conditions.J Clin Invest. 1998; 101:479–486. doi: 10.1172/JCI973.CrossrefMedlineGoogle Scholar10. Goto S, Tomita A.New antithrombotics for secondary prevention of acute coronary syndrome.Clin Cardiol. 2014; 37:178–187. doi: 10.1002/clc.22233.CrossrefMedlineGoogle Scholar11. Tomita A, Tamura N, Nanazawa Y, Shiozaki S, Goto S.Development of virtual platelets implementing the functions of three platelet membrane proteins with different adhesive characteristics.J Atheroscler Thromb. 2015; 22:201–210.CrossrefMedlineGoogle Scholar12. Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW; TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.N Engl J Med. 2012; 366:20–33. doi: 10.1056/NEJMoa1109719.CrossrefMedlineGoogle Scholar13. Morrow DA, Braunwald E, Bonaca MP, Ameriso SF, Dalby AJ, Fish MP, Fox KA, Lipka LJ, Liu X, Nicolau JC, Ophuis AJ, Paolasso E, Scirica BM, Spinar J, Theroux P, Wiviott SD, Strony J, Murphy SA; TRA 2P–TIMI 50 Steering Committee and Investigators. Vorapaxar in the secondary prevention of atherothrombotic events.N Engl J Med. 2012; 366:1404–1413. doi: 10.1056/NEJMoa1200933.CrossrefMedlineGoogle Scholar14. Morrow DA, Alberts MJ, Mohr JP, Ameriso SF, Bonaca MP, Goto S, Hankey GJ, Murphy SA, Scirica BM, Braunwald E; Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events–TIMI 50 Steering Committee and Investigators. Efficacy and safety of vorapaxar in patients with prior ischemic stroke.Stroke. 2013; 44:691–698. doi: 10.1161/STROKEAHA.111.000433.LinkGoogle Scholar15. Udell JA, Steg PG, Scirica BM, Eagle KA, Ohman EM, Goto S, Alsheikh-Ali AA, Porath A, Corbalan R, Umez-Eronini AA, Hoffman EB, Wilson PW, Bhatt DL; Reduction of Atherothrombosis for Continued Health (REACH) Registry Investigators. Metabolic syndrome, diabetes mellitus, or both and cardiovascular risk in outpatients with or at risk for atherothrombosis.Eur J Prev Cardiol. 2014; 21:1531–1540. doi: 10.1177/2047487313500541.CrossrefMedlineGoogle Scholar16. Duzenli MA, Ozdemir K, Aygul N, Soylu A, Tokac M.Comparison of increased aspirin dose versus combined aspirin plus clopidogrel therapy in patients with diabetes mellitus and coronary heart disease and impaired antiplatelet response to low-dose aspirin.Am J Cardiol. 2008; 102:396–400. doi: 10.1016/j.amjcard.2008.03.074.CrossrefMedlineGoogle Scholar17. Angiolillo DJ, Jakubowski JA, Ferreiro JL, Tello-Montoliu A, Rollini F, Franchi F, Ueno M, Darlington A, Desai B, Moser BA, Sugidachi A, Guzman LA, Bass TA.Impaired responsiveness to the platelet P2Y12 receptor antagonist clopidogrel in patients with type 2 diabetes and coronary artery disease.J Am Coll Cardiol. 2014; 64:1005–1014. doi: 10.1016/j.jacc.2014.06.1170.CrossrefMedlineGoogle Scholar18. Goto S.Role of von Willebrand factor for the onset of arterial thrombosis.Clin Lab. 2001; 47:327–334.MedlineGoogle Scholar19. Yong AS, Pennings GJ, Chang M, Hamzah A, Chung T, Qi M, Brieger D, Behnia M, Krilis SA, Ng MK, Lowe HC, Kritharides L.Intracoronary shear-related up-regulation of platelet P-selectin and platelet-monocyte aggregation despite the use of aspirin and clopidogrel.Blood. 2011; 117:11–20. doi: 10.1182/blood-2010-04-278812.CrossrefMedlineGoogle Scholar20. Scirica BM, Bonaca MP, Braunwald E, De Ferrari GM, Isaza D, Lewis BS, Mehrhof F, Merlini PA, Murphy SA, Sabatine MS, Tendera M, Van de Werf F, Wilcox R, Morrow DA, Investigators TRAdP-TSC. Vorapaxar for secondary prevention of thrombotic events for patients with previous myocardial infarction: A prespecified subgroup analysis of the TRA 2° P-TIMI 50 trial.Lancet. 2012; 380:1317–1324.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Chen Y, Gao F, Zheng G and Gao S (2020) Enantioselective synthesis of a chiral intermediate of himbacine analogs by Burkholderia cepacia lipase A, Biotechnology Letters, 10.1007/s10529-020-02969-z, 42:12, (2643-2651), Online publication date: 1-Dec-2020. GOTO S and GOTO S (2019) Understanding of pathophysiology of thrombosis and prediction of the efficacy of medicine using simulation approachシミュレーションによる血栓症の病態予測と薬効評価, Japanese Journal of Thrombosis and Hemostasis, 10.2491/jjsth.30.856, 30:6, (856-861), . 後藤 信 (2018) 血栓形成の機序, Japanese Journal of Thrombosis and Hemostasis, 10.2491/jjsth.29.539, 29:6, (539-544), . Moschonas I and Tselepis A (2016) Increased Benefit With Vorapaxar Use in Patients With a History of Myocardial Infarction and Diabetes Mellitus, Journal of Cardiovascular Pharmacology and Therapeutics, 10.1177/1074248416662347, 22:2, (133-141), Online publication date: 1-Mar-2017. (2016) Clinical Applications of Aspirin Acetylsalicylic Acid, 10.1002/9783527685059.ch4, (263-446) Goto S, Hasebe T and Takagi S (2015) Platelets: Small in Size But Essential in the Regulation of Vascular Homeostasis – Translation From Basic Science to Clinical Medicine –, Circulation Journal, 10.1253/circj.CJ-14-1434, 79:9, (1871-1881), . Goto S and Goto S (2015) What is the meaning of P2Y12 reaction units in patients with essential thrombocythemia?, Journal of Cardiology Cases, 10.1016/j.jccase.2015.08.008, 12:6, (205-207), Online publication date: 1-Dec-2015. March 24, 2015Vol 131, Issue 12 Advertisement Article InformationMetrics © 2015 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.115.015471PMID: 25681465 Originally publishedFebruary 13, 2015 Keywordsblood plateletsEditorialsplatelet aggregation inhibitorsPDF download Advertisement SubjectsPlateletsThrombosis" @default.
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• W1997996874 title "Selection of a Suitable Patient Population for New Antiplatelet Therapy From the Large Clinical Trial Database of the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events–Thrombolysis in Myocardial Infarction 50 (TRA-2P–TIMI50) Trial" @default.
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