Abstract

Abstract Background In patients with atrial fibrillation (AF), who have suffered an intracerebral haemorrhage (ICH), the optimal stroke prevention strategy is unclear. The PRESTIGE-AF trial is a multinational randomized controlled trial designed to investigate the optimal stroke prevention strategy in patients with AF who have recently suffered an ICH. Until the results of the PRESTIGE-AF trial becomes available, data on the risk of future cerebrovascular events in AF patient surviving an ICH are important to gain knowledge on the risk in this patient group and to support the clinician in this challenging situation. Purpose To investigate the risk of cerebrovascular events in a study population of ICH survivors with AF resembling the expected trial population of the PRESTIGE-AF trial. Methods We used the Danish nationwide registries to identify all patients presenting with incident ICH and prevalent AF between 2003–2018. To resemble the expected trial population of the PRESTIGE-AF trial, key inclusion and exclusion criteria of the PRESTIGE-AF trial were applied [Flowchart]. Patients were followed for up to one year in the Danish Stroke Registry, and outcomes (recurrent ICH, cerebrovascular ischaemic event, and all-cause death) were reported according to initiation/resumption of oral anticoagulant therapy (OAC) during follow-up. Results A total of 1,885 patients were included in the study. At one year after the incident ICH, we observed 40 recurrent ICH, 63 cerebrovascular ischaemic events, 88 all strokes, and 650 all-cause deaths [Figure]. When splitting the follow-up period according to initiation/resumption of OAC during follow-up, 526 patients initiated/resumed OAC during follow-up. The median time to initiation/resumption of OAC was 5.3 months (IQR: 1.1–12.0). For the subpopulation of patients not initiating/resuming OAC during follow-up, we observed a 2.6% risk of cerebrovascular ischaemic events, a 1.5% risk of recurrent ICH, and a 30.3% risk of all-cause death at one year after the incident ICH. For the subpopulation of patients initiating/resuming OAC during follow-up, we observed a 2.8% risk of recurrent ICH, a 3.2% risk of cerebrovascular ischaemic events, and a 22.0% risk of all-cause death at one year after the incident ICH. Conclusion In this observational cohort study, we identified a population of ICH survivors with concomitant AF mirroring the expected PRESTIGE-AF trial population. One year after the incident ICH, we observed more cerebrovascular ischaemic events than recurrent ICH events, which was also evident for the subpopulation of patients initiating/resuming OAC during follow-up. The results of the PRESTIGE-AF trial are warranted to determine optimal stroke prevention among ICH survivors with concomitant AF. Funding Acknowledgement Type of funding sources: Public grant(s) – EU funding. Main funding source(s): This study has received funding from the European Union's Horizon 2020 research and innovation programme. FlowchartFigure

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