Are you unsure whether to start anticoagulation for atrial fibrillation after intracranial haemorrhage? Time to randomise!
By: Dr Tom Moullaali, Centre for Clinical Brain Sciences, University of Edinburgh; George Institute for Global Health, Sydney
Do you start or avoid oral anticoagulation for atrial fibrillation (AF) in patients with a history of intracranial haemorrhage?
Are you unsure about the balance of potential benefits (prevention of serious thromboembolic events, including ischaemic stroke) and harms (increased risk of recurrent intracranial haemorrhage or other major bleeding)? Or about the influence of timing, or of patient factors such as brain imaging markers of cerebral small vessel disease, on the safety of the treatment?
These uncertainties might be responsible for the dramatic variation in clinical practice across the world – 14% vs. 91% of patients who meet clinical criteria for oral anticoagulation (AF and CHA2DS2-VASc score of ≥2) receive treatment in Europe and Japan, respectively.
A 2017 Cochrane Review concluded that evidence from randomised controlled trials is needed to provide robust supporting evidence for these difficult decisions; now is a good time to consider getting involved!
Here in the UK, the Start or Stop Anticoagulants Randomised Trial (www.SoSTART.ed.ac.uk) recently randomised its 190th patient, meeting the minimum target sample size set by the study team. Elsewhere, in the Netherlands, the Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation trial (http://apache-af.nl/) is also close to completing recruitment. These, and other small pilot trials will provide important safety and feasibility data needed to show a large, multicentre, international trial can be delivered. Congratulations are in order to all study teams for recruiting: keep up the hard work, and keep randomising!
Finally, the Edoxaban for Intracranial Hemorrhage Survivors with AF trial (ENRICH-AF, http://www.phri.ca/research-study/enrich-af/) aims to provide definitive evidence in a larger sample of 1200 patients across 250 sites in 20 countries. The primary efficacy objective is to evaluate whether edoxaban (60/30 mg daily) compared to standard of care (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischaemic, haemorrhagic and unspecified stroke) in high-risk atrial fibrillation (CHA2DS2-VASc of ≥2) patients with previous intracranial haemorrhage. The primary safety objective is to document the incidence of clinically relevant major bleeding.
Can you help the ENRICH-AF team achieve their goal? If you’re unsure whether to start or avoid anticoagulation for your patient with atrial fibrillation and a history intracranial haemorrhage, it’s time to randomise!