Meeting the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria was associated with a significantly higher incidence of major bleeding at 12 months post-PCI (4.2% vs 1.4%, HR 3.00).
Observational (n=6,267)
Yes
Does the ARC-HBR criteria accurately predict major bleeding in East Asian patients undergoing PCI?
The ARC-HBR criteria are valid and applicable for predicting 12-month major bleeding risk in Japanese patients undergoing contemporary PCI.
Hazard Ratio: 3 (95% CI 2.11–4.27)
Absolute Event Rate: 4.2% vs 1.4%
p-value: p=<0.001
AIMS: We aimed to evaluate the validity of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria for East Asian patients undergoing contemporary percutaneous coronary intervention (PCI) from the PENDULUM registry. METHODS AND RESULTS: This post hoc analysis included 6,267 Japanese patients undergoing PCI between December 2015 and June 2017 enrolled in PENDULUM. The primary endpoint was the incidence of major bleeding at 12 months post index PCI. In total, 3,185 (50.8%) and 3,082 (49.2%) patients were stratified to the ARC-HBR and non-ARC-HBR groups, respectively, and almost all patients had overlapping criteria. Incidence of major bleeding was 4.2% versus 1.4% in the ARC-HBR group versus the non-ARC-HBR group (hazard ratio 3.00 95% confidence interval: 2.11-4.27; p<0.001). As the number of overlapping ARC-HBR criteria increased, the incidence of major bleeding also increased. In contrast, the incidence of major bleeding was 4.2% for one major criterion, 2.1% for two minor criteria. Multivariate analysis suggested that severe CKD, anticoagulant use, acute coronary syndrome, low body weight and heart failure were independent predictors of major bleeding. CONCLUSIONS: Half of the Japanese patients who underwent PCI in the PENDULUM registry met the ARC-HBR criteria, and many patients had overlapping criteria. ARC-HBR criteria are applicable to Japanese patients undergoing contemporary PCI.
Nakamura et al. (Mon,) conducted a observational in Patients undergoing percutaneous coronary intervention (PCI) (n=6,267). High bleeding risk (ARC-HBR) status vs. Non-high bleeding risk (non-ARC-HBR) status was evaluated on Incidence of major bleeding at 12 months post index PCI (HR 3.00, 95% CI 2.11-4.27, p=<0.001). Meeting the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria was associated with a significantly higher incidence of major bleeding at 12 months post-PCI (4.2% vs 1.4%, HR 3.00).