The primary outcomes of interest were the rates of various antithrombotic therapy prescribing patterns during the initial 12-months following PCI and changes (if any) to antithrombotic therapy at 12-months (± 1 month) following the index PCI. Changes were categorized according to the predominant antithrombotic therapy pathways identified during manual medical record reviews. After categorization of antithrombotic therapy changes at 12-months, patients were followed an additional 6-months for clinical outcomes including major bleeding, clinically relevant non-major bleeding (CRNMB), major adverse cardiovascular or neurological events (MACNE), and all-cause mortality.
Clinical outcomes were identified using hospitalization ICD-9/10 codes for bleeding and thromboembolic events in “any” diagnostic position and confirmed via manual chart review. Bleeding outcome severity was categorized using the definitions of the International Society on Thrombosis and Haemostasis (ISTH). Specifically major bleeding was defined as fatal bleeding, symptomatic bleeding in a critical area or organ, or bleeding that caused a drop in hemoglobin level of 2.0 g/L or more, or that lead to the transfusion of two or more units of whole blood or red blood cells [9 (link)]. CRNMB was defined as any bleeding that required medical intervention by a healthcare professional, lead to hospitalization or an increased level of care, or prompted a face-to-face evaluation but did not meet the definition of major bleeding [10 (link)]. MACNE was defined as the occurrence of cardiovascular death, MI, stroke/non-central nervous system systemic embolism or transient ischemic attack [11 (link)]. All-cause mortality was identified through documentation of death within the EMR.
Clinical outcomes were identified using hospitalization ICD-9/10 codes for bleeding and thromboembolic events in “any” diagnostic position and confirmed via manual chart review. Bleeding outcome severity was categorized using the definitions of the International Society on Thrombosis and Haemostasis (ISTH). Specifically major bleeding was defined as fatal bleeding, symptomatic bleeding in a critical area or organ, or bleeding that caused a drop in hemoglobin level of 2.0 g/L or more, or that lead to the transfusion of two or more units of whole blood or red blood cells [9 (link)]. CRNMB was defined as any bleeding that required medical intervention by a healthcare professional, lead to hospitalization or an increased level of care, or prompted a face-to-face evaluation but did not meet the definition of major bleeding [10 (link)]. MACNE was defined as the occurrence of cardiovascular death, MI, stroke/non-central nervous system systemic embolism or transient ischemic attack [11 (link)]. All-cause mortality was identified through documentation of death within the EMR.
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