Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843

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Efficacy and Safety of Warfarin for the Treatment of Venous Thromboembolism ― A Multicenter Prospective Observational Cohort Study in Japan (AKAFUJI Study) ―
Mashio Nakamura Satoshi TamaruShigeki HirookaAtsushi HirayamaAkihiro TsujiMitsuhiro HirataMitsuru MunemasaIzumi NakagawaMasahiro ToshimaHiroaki ShimokawaYuki NishimuraToru OguraTakeshi YamamotoHirono SatokawaToru ObayashiNorikazu Yamadaon behalf of the AKAFUJI Study Investigators
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論文ID: CJ-23-0158

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Background: A large-scale prospective study of the efficacy and safety of warfarin for the treatment of venous thromboembolism (VTE) has not been conducted in Japan. Therefore, we conducted a real-world prospective multicenter observational cohort study (AKAFUJI Study; UMIN000014132) to investigate the efficacy and safety of warfarin for VTE.

Methods and Results: Between May 2014 and March 2017, 352 patients (mean [±SD] age 67.7±14.8 years; 57% female) with acute symptomatic/asymptomatic VTE were enrolled; 284 were treated with warfarin. The cumulative incidence of recurrent symptomatic VTE was higher in patients without warfarin than in those treated with warfarin (8.7 vs. 2.2 per 100 person-years, respectively; P=0.018). The cumulative incidence of bleeding complications was not significantly different between the 2 groups. The mean prothrombin time-international normalized ratio (PT-INR) during warfarin on-treatment was <1.5 in 180 patients, 1.5–2.5 in 97 patients, and >2.5 in 6 patients. The incidence of bleeding complications was significantly higher in patients with PT-INR >2.5, whereas the incidence of recurrent VTE was not significantly different between the 3 PT-INR groups. The cumulative incidence of recurrent VTE and bleeding complications did not differ significantly among those in whom VTE was provoked by a transient risk factor, was unprovoked, or was associated with cancer.

Conclusions: Warfarin therapy with an appropriate PT-INR according to Japanese guidelines is effective without increasing bleeding complications, regardless of patient characteristics.

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© 2023, THE JAPANESE CIRCULATION SOCIETY

This article is licensed under a Creative Commons [Attribution-NonCommercial-NoDerivatives 4.0 International] license.
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