The choice of treatment was decided by the treating physician. VKA therapy was defined as treatment with phenprocoumon (NOACISP, Erlangen) or acenocoumarol/warfarin (SAMURAI‐NVAF, RAF/RAF‐DOAC, CROMIS‐2, and Verona). DOAC therapy was defined as one of the following drugs and dosages: apixaban 2.5mg or 5mg twice daily dabigatran 110mg or 150mg twice daily edoxaban 30mg or 60mg once daily or rivaroxaban 15mg or 20mg once daily (10mg or 20mg once daily in Japan, according to the results from a domestic trial 18). The following baseline variables were recorded and provided by the participating studies: age, sex, type of index event (AIS or TIA) antithrombotic treatment (no treatment, antiplatelet agents, VKA or DOAC including type of DOAC) before and after index event international normalized ration (INR) at index event (if patient was on VKA therapy) time from index event to first dose of VKA or DOAC stroke severity on admission as assessed by the National Institutes of Health Stroke Scale (NIHSS) 17 and use of intravenous thrombolysis or endovascular reperfusion therapy for index stroke. 12, 13 Details about the participating studies can be obtained from the published studies 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and prior publications. 4 The following studies were included: the single‐center prospective cohort studies from Verona, Italy, 5 Erlangen, Germany, 6 and Basel, Switzerland (Novel Oral Anticoagulants in Stroke Patients ) 7 the multicenter cohort studies Early Recurrence and Cerebral Bleeding in Patients with Acute Ischemic Stroke and Atrial Fibrillation (RAF 8 and RAF‐NOAC 9 29 centers in Europe, Asia, and North America) the Clinical Relevance of Microbleeds in Stroke study (CROMIS‐2 79 centers in the United Kingdom and 1 in The Netherlands) 10, 11 and the Stroke Acute Management with Urgent Risk‐Factor Assessment and Improvement Study on Anticoagulant Therapy in Nonvalvular Atrial Fibrillation (SAMURAI‐NVAF, 18 centers in Japan). We used pooled individual patient data from an established international collaboration of investigator‐initiated prospective cohort studies. First, are patients who have an ischemic stroke or TIA despite taking oral anticoagulants (VKA or DOAC) at increased risk of recurrent acute ischemic stroke (AIS) or other outcome events? Second, after the index event, is changing the type of anticoagulant (VKA or DOAC or type of DOAC) associated with reduced rates of AIS? We aimed to answer the following questions in patients with AF and an index acute ischemic stroke or transient ischemic attack (TIA). 3 Among patients with an ischemic stroke despite anticoagulant therapy, it is unknown whether changing the type of anticoagulant (VKA to DOAC, DOAC to VKA, or switching to an alternative DOAC) reduces the risk of recurrence. Direct oral anticoagulants (DOAC) are a proven effective alternative to vitamin K antagonists (VKA) for oral anticoagulation in patients with AF. Moreover, the optimal prevention strategy to reduce further recurrence risk in such patients is unknown. 2 These patients might be at particularly high risk of further ischemic stroke events, but this has not been investigated. 1 This is often regarded as a treatment failure, whose mechanisms include incompliance, reduced pharmacological efficacy of the anticoagulant in individual patients, or other factors such as alternative stroke mechanisms (eg, small vessel occlusion). Nevertheless, patients with AF may still have an ischemic stroke despite taking oral anticoagulants. Oral anticoagulation substantially reduces the risk for ischemic stroke and systemic embolism in patients with atrial fibrillation (AF).
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