Patients meeting the Japanese high bleeding risk (J-HBR) criteria had a significantly higher 5-year cumulative incidence of BARC type 3 or 5 major bleeding compared to those without J-HBR (23.1% vs. 8.4%, HR 2.95).
Cohort (n=13,258)
Yes
Does the Japanese version of high bleeding risk (J-HBR) criteria predict bleeding outcomes in Japanese patients undergoing first PCI?
The J-HBR criteria effectively identify Japanese patients at very high bleeding risk after PCI, capturing a larger proportion (64%) of the population than the standard ARC-HBR criteria.
Hazard Ratio: 2.95 (95% CI 2.66–3.27)
Absolute Event Rate: 23.1% vs 8.4%
p-value: p=<0.0001
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.
A 2020 study conducted a cohort in Coronary artery disease requiring percutaneous coronary intervention (n=13,258). Japanese version of high bleeding risk (J-HBR) criteria vs. No high bleeding risk (no-HBR) was evaluated on Major bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (HR 2.95, 95% CI 2.66-3.27, p=<0.0001). Patients meeting the Japanese high bleeding risk (J-HBR) criteria had a significantly higher 5-year cumulative incidence of BARC type 3 or 5 major bleeding compared to those without J-HBR (23.1% vs. 8.4%, HR 2.95).