Abstract 12239: Efficacy and Safety of the Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Japan: A Retrospective Cohort Study Using the National Database of Health Insurance Claim

Abstract

Objective: Examine efficacy and safety of anticoagulation (AC) treatment in Japanese Acute hospitals Methods: Insurance claim data of 66, 693 patients who received anticoagulant treatment were extracted from 352 (20%) of hospitals of all 1580 hospitals enrolled in national database of health insurance, Diagnosis Procedure Combination (DPC) database. All the patients received anticoagulant treatment using warfarin and/or non-vitamin K antagonist oral anticoagulants (NOAC) during 10/1/2012 and 9/30/2014. NOACs in this study are: dabigatran, rivaroxaban, and apixaban. We observed incidence of ischemic stroke as efficacy related outcome. We also observed following unfavorable events: intracranial hemorrhage, gastrointestinal hemorrhage, and all-cause death. Outcomes were compared between group of warfarin-treated patients and NOACs-treated patients. Findings: Of 66,693 patients treated with anticoagulants, 50,523(77.3%) were treated with Warfarin, 16,170(24.8%) were with NOACs. Among 66,693 patients, 1,378 patients (2.1%) who were treated with both drugs were excluded for the analysis. The event rate of ischemic stroke was similar between warfarin-treated group and NOACs-treated group 849 (1.68%) vs 245 (1.52%), respectively (p=0.16). On the other hands, unfavorable events were observed significantly more frequently in warfarin-treated group than NOACs-treated group: all-cause death, 4,875(9.6%) vs 724(4.5%), respectively (p<0.001); intracranial hemorrhage, 685(1.4%) vs 94(0.6%), respectively (p<0.001); gastrointestinal hemorrhage, 883 (1.74%) vs 157 (0.97%), p<0.001). Conclusions: This retrospective study based on large-scale national database revealed that efficacy of warfarin and NOACs were equivalent. However, risk of all-cause death and unfavorable bleeding events was higher in warfarin-treated patients than NOACs-treated patients. This study demonstrates that NOACs contribute a beneficial effect on anticoagulation treatment for the patients with atrial fibrillation in the real world.