Abstract
Background
Atrial fibrillation (AF) patients surviving an intracerebral haemorrhage (ICH) present a clinical challenge. The PRESTIGE-AF trial is an ongoing trial designed to investigate the optimal stroke prevention strategy in AF patients who have suffered an ICH.
Purpose
To describe baseline clinical characteristics of a study population similar to the expected PRESTIGE-AF trial.
Methods
The patient population was identified from the Danish Stroke Registry, linked with additional registries to obtain information on comorbidities and medication. Specific incl/excl criteria from the PRESTIGE-AF trial were applied, including indication for OAC treatment due to AF and the ICH was not related to trauma.
Results
From 2003–2015 a total of 1405 patients with AF and ICH were included, mean age of 79.4 years [Table]. 40% had suffered a “mild” index ICH, and approximately 25% had a “moderate” or a “severe” index event based on the SSS score. Hypertension (75%) and prior thromboembolic events (33%) were common comorbidities. In the year before the index ICH, 27% recieved antiplatelet therapy, 34% OAC, and 22% receiving both treatments.
Table 1 Demographics and clinical characteristics Percent (number) Number of patients 1,405 Females 695 (49.5) Age, mean (SD) 79.4 (8.8) Scandinavian Stroke Scale*, median (IQR) 40.0 (22.0–50.0) “Mild” intracerebral haemorrhage (43–58) 563 (40.1) “Moderate” intracerebral haemorrhage (26–42) 377 (26.8) “Severe” intracerebral haemorrhage (<26) 361 (25.7) Hypertension 1067 (75.9) Prior thromboembolism 460 (32.7) CHA2 DS2 -VASc score, mean (SD) 4.2 (1.3) Antiplatelet therapy (mono) 377 (26.8) VKA treatment 436 (31.0) NOAC treatment 40 (2.9) OAC and antiplatelet treatment 311 (22.1) *Scale from 0–58; lower score indicates more severe stroke; 7% missing information.
Conclusion
The identified study population using the criteria for the PRESTIGE-AF trial were generally elderly and had a high prevalence of hypertension and prior stroke. The PRESTIGE-AF trial is required to determine optimal stroke prevention treatment in a population of AF patients presenting with ICH.
Acknowledgement/Funding
This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 754517