Outcomes and follow-up
death, bleeding, systemic thromboembolism, ischemic stroke, thromboembolism, embolism, heart failure
BLEEDING, ADVERSE EVENTS, ISCHEMIC STROKE, EMBOLISM, SECONDARY, ACUTE CORONARY SYNDROME, THROMBOEMBOLISM, EVENTS, HEART FAILURE
The incidence of clinical adverse events was assessed through 6 and 12-month follow-up of each patient. Consistently with the primary analysis of the trial, we defined the primary outcome for this analysis as the composite all-cause death, ischemic stroke or systemic thromboembolism, and rehospitalization. We also investigated several exploratory secondary outcomes: all-cause death, thromboembolism (i.e., ischemic stroke or systemic thromboembolism), bleeding events (intracranial and extracranial), the composite of cardiovascular outcomes (recurrent AF, heart failure and acute coronary syndrome), and rehospitalization. The effect of the mAFA intervention was evaluated, for each outcome, according to the history of previous thromboembolism (i.e., patients with vs. without ischemic stroke or systemic embolism).