High bleeding risk and clinical outcomes in East Asian patients undergoing percutaneous coronary intervention: the PENDULUM registry
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Masato Nakamura1, Kazushige Kadota, Koichi Nakao
1Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
Insights
The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria are applicable to Japanese patients undergoing percutaneous coronary intervention (PCI). Half of patients met ARC-HBR criteria, with increased bleeding risk correlating to more criteria met.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Research
Background:
- High bleeding risk (HBR) criteria are crucial for managing patients undergoing percutaneous coronary intervention (PCI).
- The Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria require validation in diverse populations, including East Asians.
Purpose of the Study:
- To evaluate the applicability and validity of the ARC-HBR criteria in Japanese patients undergoing contemporary PCI.
- To assess the association between ARC-HBR criteria and major bleeding events in this population.
Main Methods:
- A post hoc analysis of 6,267 Japanese patients from the PENDULUM registry undergoing PCI.
- Patients were stratified into ARC-HBR and non-ARC-HBR groups based on defined criteria.
- Major bleeding incidence at 12 months post-PCI was the primary endpoint.
Main Results:
- 50.8% of patients met the ARC-HBR criteria, with many having overlapping criteria.
- The incidence of major bleeding was significantly higher in the ARC-HBR group (4.2%) compared to the non-ARC-HBR group (1.4%).
- Increasing numbers of ARC-HBR criteria correlated with higher bleeding rates; severe CKD, anticoagulant use, and ACS were independent predictors.
Conclusions:
- The ARC-HBR criteria are applicable to Japanese patients undergoing contemporary PCI.
- A significant proportion of patients meet HBR criteria, highlighting the need for risk stratification.
- Findings support the use of ARC-HBR criteria for identifying high-bleeding-risk patients in this demographic.
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.
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