International journal of stroke : official journal of the International Stroke Society · 2026
Long-term risk of bleeding events in patients taking antithrombotic agents for cerebrovascular or cardiovascular disease.
СтатьяНазвание и аннотация: Перевод в очереди
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Yoshimura Sohei, Miwa Kaori, Koga Masatoshi, Tanaka Kanta, Yagita Yoshiki, Nagakane Yoshinari, Hoshino Haruhiko, Terasaki Tadashi, Shiozawa Masayuki, Iguchi Yasuyuki, Arakawa Shuji, Fujimoto Shigeru, Okada Yasushi, Ihara Masafumi, Takahashi Shinichi, Doijiri Ryosuke, Sasaki Makoto, Yakushiji Yusuke, Hirano Teruyuki, Toyoda Kazunori, for BAT2 Investigators
Аннотация
BACKGROUND: Antithrombotic agents are essential for preventing cerebrovascular and cardiovascular diseases; however, bleeding complications remain a major concern, particularly among elderly patients and those receiving combination therapy.
AIMS: We designed the Bleeding with Antithrombotic Therapy 2 (BAT2) Study, a prospective multicenter registry involving hospitals from a clinical research network in Japan, to clarify the risk of bleeding events in patients taking antithrombotic agents for cerebrovascular and cardiovascular diseases in recent clinical settings.
METHODS: This prospective, multicenter, observational study followed bleeding and ischemic events for up to 2 years in patients with cerebrovascular and cardiovascular diseases. The primary outcome was major bleeding, and secondary outcomes included intracranial hemorrhage (ICH).
RESULTS: The 5250 patients enrolled comprised 3134 (70 ± 11 years; male, 66.6%; HASBLED ⩾ 3, 32.8%) treated with single antiplatelet therapy (SAPT), 551 (71 ± 11 years; 25.8%; 40.8%, respectively) with dual antiplatelet therapy (DAPT), 870 (75 ± 10 years; 37.1%; 39.8%, respectively) with direct oral anticoagulant (DOAC) alone, 433 (72 ± 12 years; 34.2%; 41.4%, respectively) with warfarin alone, 143 (76 ± 8 years; 16.8%; 42.7%, respectively) with DOAC plus antiplatelet agents (AP), and 119 (73 ± 12 years; 18.5%; 47.5%, respectively) with warfarin plus AP. During follow-up (median, 1.98 years), 93 patients experienced major bleeding, and 55 developed ICH. Compared with the SAPT group (37 events, 0.63%/year), the DOAC (18 events, 1.12%/year; adjusted hazard ratio (aHR) = 1.94, 95% confidence interval (CI) = 1.09-3.46), warfarin (16 events, 2.02%/year; 3.44, 1.90-6.23), and DOAC plus AP groups (six events, 2.24%/year; 3.07, 1.28-7.35) exhibited significantly higher risks of major bleeding after multivariable adjustment. DAPT (aHR 2.47, 95% CI = 1.11-5.48), warfarin (5.38, 2.65-10.92), and DOAC plus AP (3.86, 1.30-11.47) had significantly higher risks of ICH than SAPT. The DAPT (2.28, 95% CI = 1.65-3.14), DOAC plus AP (1.96, 1.08-3.56), and warfarin plus AP (2.83, 1.62-4.92) groups showed significantly higher risks of ischemic events than the SAPT group.
CONCLUSION: Oral anticoagulant alone and DOAC with antiplatelet therapy were associated with higher risks of major bleeding events than SAPT in long-term follow-up for patients with stroke and cardiovascular disease.
AIMS: We designed the Bleeding with Antithrombotic Therapy 2 (BAT2) Study, a prospective multicenter registry involving hospitals from a clinical research network in Japan, to clarify the risk of bleeding events in patients taking antithrombotic agents for cerebrovascular and cardiovascular diseases in recent clinical settings.
METHODS: This prospective, multicenter, observational study followed bleeding and ischemic events for up to 2 years in patients with cerebrovascular and cardiovascular diseases. The primary outcome was major bleeding, and secondary outcomes included intracranial hemorrhage (ICH).
RESULTS: The 5250 patients enrolled comprised 3134 (70 ± 11 years; male, 66.6%; HASBLED ⩾ 3, 32.8%) treated with single antiplatelet therapy (SAPT), 551 (71 ± 11 years; 25.8%; 40.8%, respectively) with dual antiplatelet therapy (DAPT), 870 (75 ± 10 years; 37.1%; 39.8%, respectively) with direct oral anticoagulant (DOAC) alone, 433 (72 ± 12 years; 34.2%; 41.4%, respectively) with warfarin alone, 143 (76 ± 8 years; 16.8%; 42.7%, respectively) with DOAC plus antiplatelet agents (AP), and 119 (73 ± 12 years; 18.5%; 47.5%, respectively) with warfarin plus AP. During follow-up (median, 1.98 years), 93 patients experienced major bleeding, and 55 developed ICH. Compared with the SAPT group (37 events, 0.63%/year), the DOAC (18 events, 1.12%/year; adjusted hazard ratio (aHR) = 1.94, 95% confidence interval (CI) = 1.09-3.46), warfarin (16 events, 2.02%/year; 3.44, 1.90-6.23), and DOAC plus AP groups (six events, 2.24%/year; 3.07, 1.28-7.35) exhibited significantly higher risks of major bleeding after multivariable adjustment. DAPT (aHR 2.47, 95% CI = 1.11-5.48), warfarin (5.38, 2.65-10.92), and DOAC plus AP (3.86, 1.30-11.47) had significantly higher risks of ICH than SAPT. The DAPT (2.28, 95% CI = 1.65-3.14), DOAC plus AP (1.96, 1.08-3.56), and warfarin plus AP (2.83, 1.62-4.92) groups showed significantly higher risks of ischemic events than the SAPT group.
CONCLUSION: Oral anticoagulant alone and DOAC with antiplatelet therapy were associated with higher risks of major bleeding events than SAPT in long-term follow-up for patients with stroke and cardiovascular disease.