Abstract TP240: Safety of Dabigatran in Patients With Acute Minor Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack and Cerebral Microbleeds: A Post Hoc Analysis of the DATAS-II Randomized Trial

Abstract

Introduction: Cerebral microbleeds are reported to predict risk of hemorrhagic transformation (HT) in patients with acute ischemic stroke. We aimed to investigate whether the effect of dabigatran (vs. aspirin) in patients with acute minor non-cardioembolic ischemic stroke/TIA is modified by baseline microbleeds on MRI. Methods: This is a post hoc analysis of the DATAS-II trial that randomized 305 patients with acute minor non-cardioembolic ischemic stroke/TIA to dabigatran (150/110 mg twice daily) or aspirin (81 mg daily) for 30 days. MRIs of patients with T2*-weighted sequences on their baseline scans underwent blinded central adjudication for microbleeds. Results: A total of 251 participants (mean age=66±13 years, 36% women, median [IQR] time from symptom onset to randomization 40 [27-55] hours; mean NIHSS=1.5±1.9) were included in these analyses, of whom 82 (33%) had baseline microbleeds. On 30-day MRI, 6% (n=14) developed HT, and 80% (n=191) achieved mRS 0-1 at 90 days. In multivariable logistic regression analyses, we found no association between microbleeds and HT (adjusted odds ratio [aOR], 0.76; 95% CI, 0.18-3.23) on 30-day MRI or mRS 0-1 at 90 days (aOR, 1.54; 95% CI, 0.70-3.41). The rates of HT and mRS 0-1 in patients with microbleeds were 3% on dabigatran and 4% on aspirin (OR, 0.71; 95% CI, 0.06-8.17), and 74% on dabigatran and 84% on aspirin (OR, 0.54; 95% CI, 0.18-1.64), respectively. The presence, severity, or location of microbleeds did not modify the effect of dabigatran on these outcomes (p-interaction>0.05). Conclusions: Early dabigatran treatment appears safe in patients with acute minor non-cardioembolic ischemic stroke/TIA and hemorrhage-prone cerebral small vessel disease marked by microbleeds on MRI.