The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Coronary interventions - Mini Focus on Antithrombotic Therapy

High bleeding risk and clinical outcomes in East Asian patients undergoing percutaneous coronary intervention: the PENDULUM registry

EuroIntervention 2021;16:1154-1162. DOI: 10.4244/EIJ-D-20-00345

1. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan; 2. Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan; 3. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan; 4. Department of Cardiovascular Medicine, Shiga University of Medical Science, Otsu, Japan; 5. Division of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan; 6. Cardiovascular Medicine Center, Fukuoka Sanno Hospital, Fukuoka, Japan; 7. Division of Cardiology, Department of Internal Medicine, Teikyo University, Tokyo, Japan; 8. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan; 9. Medical Science Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan; 10. Department of Medical Statistics, School of Medicine, Toho University, Tokyo, Japan

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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