Determination of clinical endpoints of bleeding and SSE
Bleeding events were categorized into major and minor bleeding, by the International Society on Thrombosis and Haemostasis (ISTH) criteria [20]. Major bleeding was defined as (1) fatal bleeding, or (2) bleeding in a critical area or organ, for example intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome, or (3) bleeding causing a fall in hemoglobin level of ≥20 g L-1 (1.24 mmol L-1) or leading to transfusion of ≥2 units of whole blood or red cells. Minor bleeding was defined as any overt bleeding that did not fall under the ISTH major bleeding criteria.
Major bleeding and SSE events were adjudicated by the study team comprising a cardiologist and a cardiology specialist pharmacist based on doctors’ diagnoses obtained from electronic medical records (EMRs). Minor bleeding events were likewise obtained from EMRs or based on clinical signs and symptoms self-reported by patients during the follow-up phone interviews.