Korean Circ J.  2017 Nov;47(6):833-841. 10.4070/kcj.2017.0158.

Real-world Data and Recommended Dosage of Non-vitamin K Oral Anticoagulants for Korean Patients

• Joung B

• KMID: 2396475
• DOI: http://doi.org/10.4070/kcj.2017.0158

Abstract

Regulatory approvals of non-vitamin K antagonist oral anticoagulants (NOACs) have been based on large randomized phase III trials evaluating dabigatran, rivaroxaban, apixaban, or edoxaban relative to warfarin for atrial fibrillation (AF). The results of the trials showed that all NOACs were at least non-inferior to warfarin in the prevention of stroke/thromboembolism and showed lower rates of intracranial bleeding than those associated with warfarin. However, the trials were designed differently, varied in the inclusion/exclusion criteria, and used either one dose or a low/high dose of the NOAC drug. Some of these differences have challenged the ability to directly compare various NOACs, and comparative data on effectiveness and intracranial bleeding are sparse in "real-world" patients. Real-world data complement data from large randomized phase III trials by providing new aspects of the "real-world" absolute risks of ischemic and hemorrhagic stroke associated with NOACs vs. warfarin. Moreover, "real-world" fragile patients might have been included (e.g., patients with increased risk of bleeding, liver disease, and chronic kidney disease), although these patients would be less represented in trials. This paper introduces recently published real-world data of NOACs and further suggests the recommended dosage of NOACs for Korean patients.

Keyword

Atrial fibrillation; Anticoagulants; Factor Xa inhibitors; Clinical trial

MeSH Terms

Anticoagulants*
Atrial Fibrillation
Complement System Proteins
Dabigatran
Factor Xa Inhibitors
Hemorrhage
Humans
Kidney
Liver Diseases
Rivaroxaban
Stroke
Warfarin
Anticoagulants
Complement System Proteins
Dabigatran
Factor Xa Inhibitors
Rivaroxaban
Warfarin

Figure

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  Figure 1 Comparison of each NOAC and warfarin in risk of stroke/TE in patients with AF. AF = atrial fibrillation; CI = confidence interval; HR = hazard ratio; NOAC = non-vitamin K antagonist oral anticoagulant; TE = thromboembolism.

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  Figure 2 Rivaroxaban compared with dabigatran in risk of stroke/TE in patients with AF. AF = atrial fibrillation; CI = confidence interval; HR = hazard ratio; IS = ischemic stroke; TE = thromboembolism.

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  Figure 3 Comparison of each NOAC and warfarin in risk of major bleeding in patients with AF. AB = any bleeding; AF = atrial fibrillation; CI = confidence interval; HR = hazard ratio; ICH = intracranial hemorrhage; NOAC = non-vitamin K antagonist oral anticoagulant.

• 

  Figure 4 Comparison of NOACs in risk of major bleeding in patients with AF. AF = atrial fibrillation; CI = confidence interval; ECH = extracranial hemorrhage; HR = hazard ratio; NOAC = non-vitamin K antagonist oral anticoagulant.

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