Results:

Major criterion for ARC-HBR include clinical diagnoses, which confer BARC 3 or 5 bleeding risk ≥4% at 1 year or a risk of intracranial hemorrhage (ICH) of ≥1% at 1 year:

1. Long-term oral anticoagulation
2. Severe or end-stage chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] <30 ml/min)
3. Hemoglobin <11 g/dl
4. Spontaneous bleeding requiring hospitalization and transfusion in the past 6 months
5. Moderate to severe baseline thrombocytopenia (platelet count <100 x 109/L)
6. Chronic bleeding diathesis
7. Liver cirrhosis with portal hypertension
8. Active cancer in the past 12 months
9. Previous spontaneous ICH (at any time)
10. Previous traumatic ICH within the past 12 months
11. Presence of known brain arteriovenous malformations
12. Moderate to severe ischemic stroke within the past 6 months
13. Nondeferrable major surgery on dual antiplatelet therapy
14. Recent major surgery or trauma within 30 days before PCI

Minor criterion for ARC-HBR is defined as any criterion that, in isolation, is considered to confer increased bleeding risk, with a BARC 3 or 5 bleeding rate of <4% at 1 year:

1. Age >75 years
2. Moderate CKD (eGFR 30-59 ml/min)
3. Hemoglobin 11-12.9 g/dl for men and 11-11.9 g/dl for women
4. Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months not meeting major criterion
5. Long-term use of oral nonsteroidal anti-inflammatory drugs or steroids
6. Any ischemic stroke at any time not meeting major criterion

These 20 clinical criteria were established based on consensus and available published evidence. Patients are considered at HBR if at least one major or two minor criteria are present. This definition, unlike risk scores, is binary; either the patient is HBR or not. The authors aimed to establish a consistent definition, which can be used in clinical studies to define patients undergoing PCI who are at HBR. This would allow for more consistently identifying risks and benefits of treatments for patients who are at HBR.