Background and Aims:
In the Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate versus acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS) trial, dabigatran was not superior to acetylsalicylic acid (ASA) for the prevention of recurrent stroke. Our prespecified subgroup analysis evaluated results in patients enrolled in East Asia.
Overall, 5390 patients diagnosed with ESUS (564 centres; 42 countries) were randomly assigned to dabigatran (150mg or 110mg twice daily) or ASA and followed up for 0.5–3.5 years. The primary efficacy outcome was time to recurrent stroke. A Cox proportional hazards regression model was used for the analysis of outcomes.
Out of 5390 participants, 988 patients were randomized in East Asia (Japan 599, Korea 187, China 109, Taiwan 93). Mean age was 65.3 years, 31.6% were women and the median duration of follow-up was 18.8 months. Efficacy and safety results are shown in the table. The hazard ratios for recurrent stroke and major bleeding (dabigatran vs ASA) were 0.65 (95% CI, 0.41–1.03) and 1.19 (95% CI 0.62–2.30), respectively.
In patients with ESUS in East Asia, dabigatran was not superior to ASA in preventing recurrent stroke and did not significantly increase the risk of major bleeding; reflecting the pattern of results observed in the overall study population.