Real-World Safety and Effectiveness of a 4-Factor Prothrombin Complex Concentrate in Japanese Patients Experiencing Major Bleeding: A Post-marketing Surveillance Study

Toyoda K, Arihiro S, Todo K, et al. Trends in oral anticoagulant choice for acute stroke patients with nonvalvular atrial fibrillation in Japan: the SAMURAI-NVAF study. Int J Stroke. 2015;10:836–42.

Article  PubMed  PubMed Central  Google Scholar 

Shehab N, Sperling LS, Kegler SR, Budnitz DS. National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin. Arch Intern Med. 2010;170:1926–33.

Article  PubMed  Google Scholar 

Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.

Article  CAS  PubMed  Google Scholar 

Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91.

Article  CAS  PubMed  Google Scholar 

Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92.

Article  CAS  PubMed  Google Scholar 

Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–104.

Article  CAS  PubMed  Google Scholar 

Ono K, Iwasaki Y, Akao M, et al. JCS/JHRS 2020 Guideline on pharmacotherapy of cardiac arrhythmias. Circ J. 2022;86:1790–924.

Article  CAS  PubMed  Google Scholar 

Chen A, Stecker E, Warden BA, et al. Direct oral anticoagulant use: a practical guide to common clinical challenges. J Am Heart Assoc. 2020;9:e017559. https://doi.org/10.1161/JAHA.120.017559.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021;42:373–498.

Article  PubMed  Google Scholar 

Schulman S, Beyth RJ, Kearon C, Levine MN, American College of Chest Physicians. Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133:257S–298S.

Article  CAS  PubMed  Google Scholar 

Fitzmaurice DA, Blann AD, Lip GY. Bleeding risks of antithrombotic therapy. BMJ. 2002;325:828–31.

Article  PubMed  PubMed Central  Google Scholar 

Lip GY, Andreotti F, Fauchier L, et al. Bleeding risk assessment and management in atrial fibrillation patients: a position document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis. Europace. 2011;13:723–46.

Article  PubMed  Google Scholar 

Fang MC, Go AS, Chang Y, et al. Death and disability from warfarin-associated intracranial and extracranial hemorrhages. Am J Med. 2007;120:700–5.

Article  PubMed  PubMed Central  Google Scholar 

Fang MC, Go AS, Chang Y, et al. Thirty-day mortality after ischemic stroke and intracranial hemorrhage in patients with atrial fibrillation on and off anticoagulants. Stroke. 2012;43:1795–9.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ageno W, Gallus AS, Wittkowsky A, et al. Oral anticoagulant therapy: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141:e44S–e88S.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Holland L, Warkentin TE, Refaai M, et al. Suboptimal effect of a three-factor prothrombin complex concentrate (Profilnine-SD) in correcting supratherapeutic international normalized ratio due to warfarin overdose. Transfusion. 2009;49:1171–7.

Article  CAS  PubMed  Google Scholar 

Greenberg SM, Ziai WC, Cordonnier C, et al. 2022 guideline for the management of patients with spontaneous intracerebral hemorrhage: a guideline from the American Heart Association/American Stroke Association. Stroke. 2022;53:e282–361.

Article  CAS  PubMed  Google Scholar 

Pabinger I, Brenner B, Kalina U, et al. Prothrombin complex concentrate (Beriplex PN) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008;6:622–31.

Article  CAS  PubMed  Google Scholar 

Sarode R, Milling TJ Jr, Refaai MA, et al. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013;128:1234–43.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Goldstein JN, Refaai MA, Milling TJ Jr, et al. Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015;385:2077–87.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Inoue H, Okumura K, Atarashi H, et al. Target international normalized ratio values for preventing thromboembolic and hemorrhagic events in Japanese patients with non-valvular atrial fibrillation: results of the J-RHYTHM Registry. Circ J. 2013;77:2264–70.

Article  PubMed  Google Scholar 

Yamashita T, Inoue H, Okumura K, et al. Warfarin anticoagulation intensity in Japanese nonvalvular atrial fibrillation patients: a J-RHYTHM Registry analysis. J Cardiol. 2015;65:175–7.

Article  PubMed  Google Scholar 

Kodani E, Atarashi H, Inoue H, et al. Target intensity of anticoagulation with warfarin in Japanese patients with valvular atrial fibrillation: subanalysis of the J-RHYTHM Registry. Circ J. 2015;79:325–30.

Article  PubMed  Google Scholar 

Kushimoto S, Fukuoka T, Kimura A, et al. Efficacy and safety of a 4-factor prothrombin complex concentrate for rapid vitamin K antagonist reversal in Japanese patients presenting with major bleeding or requiring urgent surgical or invasive procedures: a prospective, open-label, single-arm phase 3b study. Int J Hematol. 2017;106:777–86.

Article  CAS  PubMed  Google Scholar 

Connolly SJ, Crowther M, Eikelboom JW, et al. Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Engl J Med. 2019;380:1326–35.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Milling TJ Jr, Middeldorp S, Xu L, et al. Final study report of andexanet alfa for major bleeding with factor Xa inhibitors. Circulation. 2023;147:1026–38.

Article  CAS  PubMed  Google Scholar 

Toyoda K, Arakawa S, Ezura M, et al. Andexanet alfa for the reversal of factor Xa inhibitor activity: prespecified subgroup analysis of the ANNEXA-4 study in Japan. J Atheroscler Thromb. 2023. https://doi.org/10.5551/jat.64223.

Article  PubMed  PubMed Central  Google Scholar 

Yasaka M, Yokota H, Suzuki M, et al. Idarucizumab for emergency reversal of the anticoagulant effects of dabigatran: final results of a Japanese postmarketing surveillance study. Cardiol Ther. 2023. https://doi.org/10.1007/s40119-023-00333-6.

Article  PubMed  PubMed Central  Google Scholar 

Dai JW, Wang CH, Chu CL, et al. Effectiveness and safety of dabigatran reversal with idarucizumab in the Taiwanese population: a comparison based oneligibility for inclusion in clinical trials. Medicina (Kaunas). 2023;59:881.

Article  PubMed  Google Scholar 

Okumura K, Tomita H, Nakai M, et al. Risk factors associated with ischemic stroke in Japanese patients with nonvalvular atrial fibrillation. JAMA Netw Open. 2020;3(4):e202881.

Article  PubMed  PubMed Central  Google Scholar 

Roselli C, Chaffin MD, Weng L, et al. Multi-ethnic genome-wide association study for atrial fibrillation. Nat Genet. 2018;50(9):1225–33.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Milling TJ Jr, Refaai MA, Sarode R, et al. Safety of a four-factor prothrombin complex concentrate versus plasma for vitamin K antagonist reversal: an integrated analysis of two phase IIIb clinical trials. Acad Emerg Med. 2016;23:466–75.

Article  PubMed  PubMed Central  Google Scholar 

Shen AY, Yao JF, Brar SS, et al. Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol. 2007;50:309–15.

Article  PubMed  Google Scholar 

Toyoda K. Pharmacotherapy for the secondary prevention of stroke. Drugs. 2009;69:633–47.

Article  CAS  PubMed  Google Scholar 

van Asch CJ, Luitse MJ, Rinkel GJ, et al. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010;9:167–76.

Article  PubMed  Google Scholar 

Rieder MJ, Reiner AP, Gage BF, et al. Effect of VKORC1 haplotypes on tr

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