Ischemic and Bleeding Events After Early Initiation of Direct Oral Anticoagulants for Acute Intracranial Hemorrhage With Non-Valvular Atrial Fibrillation - A Multicenter Prospective Registry.
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Koga Masatoshi, Toyoda Kazunori, Iguchi Yasuyuki, Itabashi Ryo, Kataoka Hiroharu, Nakai Michikazu, Tanaka Kanta, Miwa Kaori, Kondo Rei, Todaka Tatemi, Kimura Naoto, Yoshimura Kunikazu, Yamashiro Shigeo, Ogishima Takahiro, Terasawa Yuka, Komoribayashi Nobukazu, Sakai Nobuyuki, Hatano Taketo, Arakawa Shuji, Sonoda Kazutaka, Hagii Joji, Hirano Teruyuki, Miyashita Fumio, Ohnishi Hiroyuki, Kimura Kazumi, Ueda Toshihiro, Maezono-Kandori Keiko, Yazawa Yukako, Kinosada Masanori, Izumo Tsuyoshi, Noshiro Shouhei, Nagasawa Hikaru, Wada Kuniyasu, Yamagami Hiroshi, Kamiyama Kenji, Takagi Yasushi, Ito Yasuhiro, Sugio Kumiko, Takita Atsushi, Kimura Tetsuya, Unverdorben Martin, Ihara Masafumi, Fujimoto Shigeru, Shoamanesh Ashkan, SAFE-ICH Registry Group
Аннотация
METHODS AND RESULTS: SAFE-ICH is a multicenter prospective observational single-arm registry study at 32 Japanese hospitals. Eligible patients had NVAF, were aged ≥20 years, and (re)initiated DOAC ≤14 days following symptomatic ICH. Among 240 patients who (re)initiated DOAC (61.3% male; mean [±SD] age 79.4±9.3 years), intraparenchymal hemorrhage predominated (84.6%), followed by subdural (12.9%), intraventricular (1.7%), and epidural (0.8%) hemorrhage. The median (interquartile range) baseline National Institutes of Health Stroke Scale score was 10 (3-16) and time to DOAC (re)initiation was 7 days (5-10 days). Edoxaban, apixaban, and rivaroxaban were used in 55.0%, 35.8%, and 9.2% of patients, respectively. The primary endpoint (composite of symptomatic ICH, any stroke, or death ≤30 days following DOAC [re]initiation) occurred in 12 (5.0%) patients. There were 4 recurrent ICH events (1.7%; all recurrent subdural hemorrhages). Five (2.1%) patients died of non-vascular causes.
CONCLUSIONS: In Japanese patients with NVAF, early DOAC (re)initiation ≤14 days after ICH appears to have an acceptable risk for ischemic and hemorrhagic events, particularly in patients with intraparenchymal hemorrhage. In patients with subdural hematoma, early DOAC (re)initiation requires vigilant monitoring.