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Published in: Cardiovascular Drugs and Therapy 1/2019

Open Access 01-02-2019 | ORIGINAL ARTICLE

Rationale, Design, and Baseline Characteristics of the Prospective Japan Acute Myocardial Infarction Registry (JAMIR)

Authors: Satoshi Honda, Kensaku Nishihira, Sunao Kojima, Misa Takegami, Yasuhide Asaumi, Makoto Suzuki, Masami Kosuge, Jun Takahashi, Yasuhiko Sakata, Morimasa Takayama, Tetsuya Sumiyoshi, Hisao Ogawa, Kazuo Kimura, Satoshi Yasuda, on behalf of the JAMIR investigators

Published in: Cardiovascular Drugs and Therapy | Issue 1/2019

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Abstract

Background

Antiplatelet therapy is a cornerstone of treatment following acute myocardial infarction (AMI). Recently, prasugrel, a new and potent antiplatelet agent, has been introduced in clinical practice. To date, however, real-world in-hospital and follow-up data in Japanese patients with AMI remain limited.

Objectives

To examine ischemic and bleeding events in Japanese patients with AMI and the association between these events and antiplatelet therapy.

Methods

The Japan AMI Registry (JAMIR) is a multicenter, nationwide, prospective registry enrolling patients with AMI from 50 institutions. The inclusion criterion is spontaneous onset of AMI diagnosed based on either the universal definition or Monitoring Trends and Determinants in Cardiovascular disease (MONICA) criteria. The major exclusion criteria are hospital admission ≥ 24 h after onset, no return of spontaneous circulation on admission following out-of-hospital cardiopulmonary arrest, and AMI as a complication of percutaneous coronary intervention or coronary artery bypass grafting. The primary end point of the study is the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Major safety end points include major bleeding based on Thrombolysis in Myocardial Infarction (TIMI) criteria and type 3 or type 5 bleeding based on Bleeding Academic Research Consortium (BARC) criteria. Between December 2015 and May 2017, a total of 3411 patients (mean age 68.1 ± 13.2 years, 23.4% female) were enrolled in the study. Patients will be followed for 1 year.

Conclusions

JAMIR will provide important information regarding contemporary practice patterns in the management of Japanese patients with AMI, their demographic and clinical characteristics, in-hospital and post-discharge outcomes, and how they are related to antiplatelet therapy.
Appendix
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Literature
1.
2.
go back to reference Ohira T, Iso H. Cardiovascular disease epidemiology in Asia: an overview. Circ J. 2013;77(7):1646–52.CrossRefPubMed Ohira T, Iso H. Cardiovascular disease epidemiology in Asia: an overview. Circ J. 2013;77(7):1646–52.CrossRefPubMed
3.
go back to reference Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. 2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the task force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018;39(2):119–77.CrossRef Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, et al. 2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the task force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018;39(2):119–77.CrossRef
4.
go back to reference Group JCSJW. Guidelines for secondary prevention of myocardial infarction (JCS 2011). Circ J. 2013;77(1):231–48.CrossRef Group JCSJW. Guidelines for secondary prevention of myocardial infarction (JCS 2011). Circ J. 2013;77(1):231–48.CrossRef
5.
6.
go back to reference Kojima S, Nishihira K, Takegami M, Nakao YM, Honda S, Takahashi J, et al. Nationwide real-world database of 20,462 patients enrolled in the Japanese Acute Myocardial Infarction Registry (JAMIR): impact of emergency coronary intervention in a super-aging population. Int J Cardiol Heart Vasc. 2018;20:1–6.PubMedPubMedCentral Kojima S, Nishihira K, Takegami M, Nakao YM, Honda S, Takahashi J, et al. Nationwide real-world database of 20,462 patients enrolled in the Japanese Acute Myocardial Infarction Registry (JAMIR): impact of emergency coronary intervention in a super-aging population. Int J Cardiol Heart Vasc. 2018;20:1–6.PubMedPubMedCentral
7.
go back to reference Selwyn AP. Prothrombotic and antithrombotic pathways in acute coronary syndromes. Am J Cardiol. 2003;91(12A):3H–11H.CrossRefPubMed Selwyn AP. Prothrombotic and antithrombotic pathways in acute coronary syndromes. Am J Cardiol. 2003;91(12A):3H–11H.CrossRefPubMed
8.
go back to reference Angiolillo DJ, Ueno M, Goto S. Basic principles of platelet biology and clinical implications. Circ J. 2010;74(4):597–607.CrossRefPubMed Angiolillo DJ, Ueno M, Goto S. Basic principles of platelet biology and clinical implications. Circ J. 2010;74(4):597–607.CrossRefPubMed
9.
go back to reference Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Alfonso F, Macaya C, Bass TA, et al. Variability in individual responsiveness to clopidogrel: clinical implications, management, and future perspectives. J Am Coll Cardiol. 2007;49(14):1505–16.CrossRefPubMed Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Alfonso F, Macaya C, Bass TA, et al. Variability in individual responsiveness to clopidogrel: clinical implications, management, and future perspectives. J Am Coll Cardiol. 2007;49(14):1505–16.CrossRefPubMed
10.
go back to reference Oh IY, Park KW, Kang SH, Park JJ, Na SH, Kang HJ, et al. Association of cytochrome P450 2C19*2 polymorphism with clopidogrel response variability and cardiovascular events in Koreans treated with drug-eluting stents. Heart. 2012;98(2):139–44.CrossRefPubMed Oh IY, Park KW, Kang SH, Park JJ, Na SH, Kang HJ, et al. Association of cytochrome P450 2C19*2 polymorphism with clopidogrel response variability and cardiovascular events in Koreans treated with drug-eluting stents. Heart. 2012;98(2):139–44.CrossRefPubMed
11.
go back to reference Man M, Farmen M, Dumaual C, Teng CH, Moser B, Irie S, et al. Genetic variation in metabolizing enzyme and transporter genes: comprehensive assessment in 3 major East Asian subpopulations with comparison to Caucasians and Africans. J Clin Pharmacol. 2010;50(8):929–40.CrossRefPubMed Man M, Farmen M, Dumaual C, Teng CH, Moser B, Irie S, et al. Genetic variation in metabolizing enzyme and transporter genes: comprehensive assessment in 3 major East Asian subpopulations with comparison to Caucasians and Africans. J Clin Pharmacol. 2010;50(8):929–40.CrossRefPubMed
12.
go back to reference Jinnai T, Horiuchi H, Makiyama T, Tazaki J, Tada T, Akao M, et al. Impact of CYP2C19 polymorphisms on the antiplatelet effect of clopidogrel in an actual clinical setting in Japan. Circ J. 2009;73(8):1498–503.CrossRefPubMed Jinnai T, Horiuchi H, Makiyama T, Tazaki J, Tada T, Akao M, et al. Impact of CYP2C19 polymorphisms on the antiplatelet effect of clopidogrel in an actual clinical setting in Japan. Circ J. 2009;73(8):1498–503.CrossRefPubMed
13.
go back to reference Jernberg T, Payne CD, Winters KJ, Darstein C, Brandt JT, Jakubowski JA, et al. Prasugrel achieves greater inhibition of platelet aggregation and a lower rate of non-responders compared with clopidogrel in aspirin-treated patients with stable coronary artery disease. Eur Heart J. 2006;27(10):1166–73.CrossRefPubMed Jernberg T, Payne CD, Winters KJ, Darstein C, Brandt JT, Jakubowski JA, et al. Prasugrel achieves greater inhibition of platelet aggregation and a lower rate of non-responders compared with clopidogrel in aspirin-treated patients with stable coronary artery disease. Eur Heart J. 2006;27(10):1166–73.CrossRefPubMed
14.
go back to reference Gurbel PA, Bergmeijer TO, Tantry US, et al. The effect of CYP2C19 gene polymorphisms on the pharmacokinetics and pharmacodynamics of prasugrel 5-mg, prasugrel 10-mg and clopidogrel 75-mg in patients with coronary artery disease. Thromb Haemost. 2014;112(3):589–97.PubMed Gurbel PA, Bergmeijer TO, Tantry US, et al. The effect of CYP2C19 gene polymorphisms on the pharmacokinetics and pharmacodynamics of prasugrel 5-mg, prasugrel 10-mg and clopidogrel 75-mg in patients with coronary artery disease. Thromb Haemost. 2014;112(3):589–97.PubMed
15.
go back to reference Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007;357(20):2001–15.CrossRefPubMed Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007;357(20):2001–15.CrossRefPubMed
16.
go back to reference Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, et al. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009;360(4):354–62.CrossRefPubMed Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, et al. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009;360(4):354–62.CrossRefPubMed
17.
go back to reference Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, et al. Cytochrome P450 genetic polymorphisms and the response to prasugrel: relationship to pharmacokinetic, pharmacodynamic, and clinical outcomes. Circulation. 2009;119(19):2553–60.CrossRefPubMed Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, et al. Cytochrome P450 genetic polymorphisms and the response to prasugrel: relationship to pharmacokinetic, pharmacodynamic, and clinical outcomes. Circulation. 2009;119(19):2553–60.CrossRefPubMed
18.
go back to reference Levine GN, Jeong YH, Goto S, Anderson JL, Huo Y, Mega JL, et al. Expert consensus document: World Heart Federation expert consensus statement on antiplatelet therapy in East Asian patients with ACS or undergoing PCI. Nat Rev Cardiol. 2014;11(10):597–606.CrossRefPubMed Levine GN, Jeong YH, Goto S, Anderson JL, Huo Y, Mega JL, et al. Expert consensus document: World Heart Federation expert consensus statement on antiplatelet therapy in East Asian patients with ACS or undergoing PCI. Nat Rev Cardiol. 2014;11(10):597–606.CrossRefPubMed
19.
go back to reference Hata J, Kiyohara Y. Epidemiology of stroke and coronary artery disease in Asia. Circ J. 2013;77(8):1923–32.CrossRefPubMed Hata J, Kiyohara Y. Epidemiology of stroke and coronary artery disease in Asia. Circ J. 2013;77(8):1923–32.CrossRefPubMed
20.
go back to reference Ueda K, Hasuo Y, Kiyohara Y, Wada J, Kawano H, Kato I, et al. Intracerebral hemorrhage in a Japanese community, Hisayama: incidence, changing pattern during long-term follow-up, and related factors. Stroke. 1988;19(1):48–52.CrossRefPubMed Ueda K, Hasuo Y, Kiyohara Y, Wada J, Kawano H, Kato I, et al. Intracerebral hemorrhage in a Japanese community, Hisayama: incidence, changing pattern during long-term follow-up, and related factors. Stroke. 1988;19(1):48–52.CrossRefPubMed
21.
go back to reference Nakamura M, Iizuka T, Sagawa K, Abe K, Chikada S, Arai M. Prasugrel for Japanese patients with acute coronary syndrome in short-term clinical practice (PRASFIT-Practice I): a postmarketing observational study. Cardiovasc Interv Ther. 2018;33(2):135–45.CrossRefPubMed Nakamura M, Iizuka T, Sagawa K, Abe K, Chikada S, Arai M. Prasugrel for Japanese patients with acute coronary syndrome in short-term clinical practice (PRASFIT-Practice I): a postmarketing observational study. Cardiovasc Interv Ther. 2018;33(2):135–45.CrossRefPubMed
22.
go back to reference Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD. Third universal definition of myocardial infarction. Circulation. 2012;126(16):2020–35.CrossRefPubMed Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD. Third universal definition of myocardial infarction. Circulation. 2012;126(16):2020–35.CrossRefPubMed
23.
go back to reference Tunstall-Pedoe H, Kuulasmaa K, Amouyel P, Arveiler D, Rajakangas AM, Pajak A. Myocardial infarction and coronary deaths in the World Health Organization MONICA Project. Registration procedures, event rates, and case-fatality rates in 38 populations from 21 countries in four continents. Circulation. 1994;90(1):583–612.CrossRefPubMed Tunstall-Pedoe H, Kuulasmaa K, Amouyel P, Arveiler D, Rajakangas AM, Pajak A. Myocardial infarction and coronary deaths in the World Health Organization MONICA Project. Registration procedures, event rates, and case-fatality rates in 38 populations from 21 countries in four continents. Circulation. 1994;90(1):583–612.CrossRefPubMed
26.
go back to reference Wiviott SD, Antman EM, Gibson CM, Montalescot G, Riesmeyer J, Weerakkody G, et al. Evaluation of prasugrel compared with clopidogrel in patients with acute coronary syndromes: design and rationale for the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 (TRITON-TIMI 38). Am Heart J. 2006;152(4):627–35.CrossRefPubMed Wiviott SD, Antman EM, Gibson CM, Montalescot G, Riesmeyer J, Weerakkody G, et al. Evaluation of prasugrel compared with clopidogrel in patients with acute coronary syndromes: design and rationale for the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 (TRITON-TIMI 38). Am Heart J. 2006;152(4):627–35.CrossRefPubMed
27.
go back to reference Cannon CP, Battler A, Brindis RG, et al. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol. 2001;38(7):2114–30.CrossRefPubMed Cannon CP, Battler A, Brindis RG, et al. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol. 2001;38(7):2114–30.CrossRefPubMed
28.
go back to reference Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial—phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988;11(1):1–11.CrossRefPubMed Rao AK, Pratt C, Berke A, Jaffe A, Ockene I, Schreiber TL, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial—phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988;11(1):1–11.CrossRefPubMed
29.
go back to reference Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736–47.CrossRefPubMed Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736–47.CrossRefPubMed
30.
go back to reference Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–51.CrossRefPubMed Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115(17):2344–51.CrossRefPubMed
31.
go back to reference Daida H, Miyauchi K, Ogawa H, Yokoi H, Matsumoto M, Kitakaze M, et al. Management and two-year long-term clinical outcome of acute coronary syndrome in Japan: prevention of atherothrombotic incidents following ischemic coronary attack (PACIFIC) registry. Circ J. 2013;77(4):934–43.CrossRefPubMed Daida H, Miyauchi K, Ogawa H, Yokoi H, Matsumoto M, Kitakaze M, et al. Management and two-year long-term clinical outcome of acute coronary syndrome in Japan: prevention of atherothrombotic incidents following ischemic coronary attack (PACIFIC) registry. Circ J. 2013;77(4):934–43.CrossRefPubMed
32.
go back to reference Kang J, Han JK, Ahn Y, Chae SC, Kim YJ, Chae IH, et al. Third-generation P2Y12 inhibitors in East Asian acute myocardial infarction patients: a nationwide prospective multicentre study. Thromb Haemost. 2018;118(3):591–600.CrossRefPubMed Kang J, Han JK, Ahn Y, Chae SC, Kim YJ, Chae IH, et al. Third-generation P2Y12 inhibitors in East Asian acute myocardial infarction patients: a nationwide prospective multicentre study. Thromb Haemost. 2018;118(3):591–600.CrossRefPubMed
33.
go back to reference Kim MC, Jeong MH, Sim DS, Hong YJ, Kim JH, Ahn Y, et al. Comparison of clinical outcomes between ticagrelor and prasugrel in patients with ST-segment elevation myocardial infarction—results from the Korea Acute Myocardial Infarction Registry-National Institutes of Health. Circ J. 2018;82:1866–73.CrossRefPubMed Kim MC, Jeong MH, Sim DS, Hong YJ, Kim JH, Ahn Y, et al. Comparison of clinical outcomes between ticagrelor and prasugrel in patients with ST-segment elevation myocardial infarction—results from the Korea Acute Myocardial Infarction Registry-National Institutes of Health. Circ J. 2018;82:1866–73.CrossRefPubMed
34.
go back to reference Myocardial infarction redefined—a consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000;21(18):1502–13. Myocardial infarction redefined—a consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000;21(18):1502–13.
Metadata
Title
Rationale, Design, and Baseline Characteristics of the Prospective Japan Acute Myocardial Infarction Registry (JAMIR)
Authors
Satoshi Honda
Kensaku Nishihira
Sunao Kojima
Misa Takegami
Yasuhide Asaumi
Makoto Suzuki
Masami Kosuge
Jun Takahashi
Yasuhiko Sakata
Morimasa Takayama
Tetsuya Sumiyoshi
Hisao Ogawa
Kazuo Kimura
Satoshi Yasuda
on behalf of the JAMIR investigators
Publication date
01-02-2019
Publisher
Springer US
Published in
Cardiovascular Drugs and Therapy / Issue 1/2019
Print ISSN: 0920-3206
Electronic ISSN: 1573-7241
DOI
https://doi.org/10.1007/s10557-018-6839-1

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