Low molecular-weight heparin versus aspirin in patients with acute ischaemic stroke and atrial fibrillation: a double-blind randomised study

Background Patients with acute ischaemic stroke and atrial fibrillation hav e an increased risk of early stroke recurrence, and anticoagulant treatment with heparins has ben widely advocated, despite missing data on the balanc e of risk and benefit. Methods Heparin in Acute Embolic Stroke Trial (HAEST) was a multicentre, ra ndomised, double-blind, and double-dummy trial on the effect of low-molecul ar-weight heparin (LMWH, dalteparin 100 IU/kg subcutaneously twice a day) o r aspirin (160 mg every day) for the treatment of 449 patients with acute i schaemic stroke and atrial fibrillation. The primary aim was to test whethe r treatment with LMWH, started within 30 h of stroke onset, is superior to aspirin for the prevention of recurrent stroke during the first 14 days. Findings The frequency of recurrent ischaemic stroke during the first 14 da ys was 19/244 (8.5%) in dalteparin-allocated patients versus 17/225 (7.5%) in aspirin-allocated patients (odds ratio=1.13, 95% CI 0.57-2.24). The seco ndary events during the first 14 days also revealed no benefit of daltepari n compared with aspirin: symptomatic cerebral haemorrhage 6/224 versus 4/22 5; symptomatic and asymptomatic cerebral haemorrhage 26/224 versus 32/225; progression of symptoms within the first 48 hours 24/224 versus 17/225; and death 21/224 versus 16/225. There were no significant differences in funct ional outcome or death at 14 days or 3 months. Interpretation The present data do not provide any evidence that LMWH is su perior to aspirin for the treatment of acute ischaemic stroke in patients w ith atrial fibrillation. However, the study could not exclude the possibili ty of smaller, but still worthwhile, effects of either of the trial drugs.