Methods
death, bleeding, Gastrointestinal tract bleeding, GI bleed, stroke, ASCVD, coronary artery disease
PERIPHERAL ARTERIAL DISEASE, BLEEDING, TRANSIENT ISCHEMIC ATTACK, GI BLEED, EVENT, STROKE, SECONDARY, DIABETES TYPE 1, ASCVD, CEREBROVASCULAR DISEASE, CORONARY ARTERY DISEASE
The ADAPTABLE study design has been previously described in detail.Overall, 15 076 participants 18 years or older with known ASCVD and at least 1 enrichment factor (age >65 years, serum creatinine >1.5 mg/dL [to convert milligrams per deciliter to micromoles per liter, multiply by 88.4], diabetes type 1 or type 2, 3-vessel coronary artery disease, cerebrovascular disease or peripheral arterial disease, left ventricular ejection fraction lower than 50%, and current cigarette smoker), no history of significant GI bleed within the last 12 months, and not currently treated with an oral anticoagulant or with ticagrelor were enrolled. The primary effectiveness end point was the time to a first occurrence of any event in the composite of death from any cause, hospitalization for MI, or hospitalization for stroke. The secondary effectiveness end points were the individual components of the primary end point, all-cause mortality, revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]), and transient ischemic attack. The primary safety end point was hospitalization for major bleeding with an associated blood product transfusion. Gastrointestinal tract bleeding was also evaluated as a safety end point. For this analysis, participants were divided into subgroups based on randomized aspirin dose and self-reported aspirin formulation (enteric-coated aspirin or uncoated aspirin) at the time of randomization. Participants who did not answer the question related to aspirin formulation, or reported that they did not know the formulation, were excluded from the analyses. It was assumed that the participants remained on the same aspirin formulation throughout the study, as information on enteric coating was not collected past baseline.