Application of the Modified High Bleeding Risk Criteria for Japanese Patients in an All-Comers Registry of Percutaneous Coronary Intervention ― From the CREDO-Kyoto Registry Cohort-3 ―
Masahiro Natsuaki, Takeshi Morimoto, Hiroki Shiomi, Natsuhiko Ehara, Ryoji Taniguchi, Toshihiro Tamura, Takeshi Tada, Satoru Suwa, Kazuhisa Kaneda, Hirotoshi Watanabe, Junichi Tazaki, Shin Watanabe, Erika Yamamoto, Naritatsu Saito, Masayuki Fuki, Teruki Takeda, Hiroshi Eizawa, Eiji Shinoda, Hiroshi Mabuchi, Manabu Shirotani, Takashi Uegaito, Mitsuo Matsuda, Mamoru Takahashi, Moriaki Inoko, Takashi Tamura, Kazuhisa Ishii, Tomoya Onodera, Hiroki Sakamoto, Takeshi Aoyama, Yukihito Sato, Kenji Ando, Yutaka Furukawa, Yoshihisa Nakagawa, Kazushige Kadota, Takeshi Kimura, on behalf of the CREDO-Kyoto PCI/CABG Registry Cohort-3 Investigators
Abstract
BACKGROUND: The prevalence of and expected bleeding event rate in patients with the Japanese version of high bleeding risk (J-HBR) criteria are currently unknown in real-world percutaneous coronary intervention (PCI) practice. METHODS AND RESULTS: We applied the J-HBR criteria in the multicenter CREDO-Kyoto registry cohort-3 that enrolled 13,258 consecutive patients who underwent first PCI. The J-HBR criteria included Japanese-specific major criteria such as heart failure, low body weight, peripheral artery disease and frailty in addition to the Academic Research Consortium (ARC)-HBR criteria. There were 8,496 patients with J-HBR, and 4,762 patients without J-HBR. The J-HBR criteria identified a greater proportion of patients with HBR than did ARC-HBR (64% and 48%, respectively). Cumulative incidence of the Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding was significantly higher in the J-HBR group than in the no-HBR group (14.0% vs. 4.1% at 1 year; 23.1% vs. 8.4% at 5 years, P<0.0001). Cumulative 5-year incidence of BARC 3/5 bleeding was 25.1% in patients with ARC-HBR, and 23.1% in patients with J-HBR. Cumulative incidence of myocardial infarction or ischemic stroke was also significantly higher in the J-HBR group than in the no-HBR group (6.9% vs. 3.6% at 1 year; 13.2% vs. 7.1% at 5 years, P<0.0001). CONCLUSIONS: The J-HBR criteria successfully identified those patients with very high bleeding risk after PCI, who represented 64% of patients in this all-comers registry.