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Safety of Dabigatran in Acute Ischemic Stroke Patients with Microbleeds: Post Hoc Analysis of DATAS-II Randomized
Pargol Balali1, Ken Butcher2, Kelvin K H Ng3
1McMaster University / Population Health Research Institute, Department of Neuroscience, Hamilton, ON, Canada.
Background:
Cerebral microbleeds are associated with an increased risk of hemorrhagic transformation (HT) following acute ischemic stroke. We investigated whether the effect of dabigatran (vs. aspirin) in patients with acute minor non-cardioembolic ischemic stroke/transient ischemic attack (TIA) is modified by baseline microbleeds on MRI.
Methods:
The Dabigatran Treatment of Acute Stroke II trial 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. Microbleeds were centrally adjudicated in patients with an interpretable blood-sensitive sequence on baseline MRI. In this post hoc analysis, we used multivariable regression models to determine the association between microbleeds and any incident HT on day-30 MRI and excellent functional outcome (modified Rankin scale = 0-1) at 90 days.
Results:
A total of 251 (82.3%) participants (mean age = 66 ± 13 years, 36% women, median [IQR] onset-to-randomization time = 40[27-55] hours; median [IQR] NIHSS = 1 [0-2]) were included, of whom 82 (33%) had microbleeds. On day-30 MRI, 6% (n = 14) developed HT, and 80% (n = 191) achieved 90-day mRS of 0-1. We found no association between microbleed presence and HT (adjusted OR = 0.84; 95%CI:0.21-3.25) or excellent functional outcome (adjusted RR = 1.09; 95%CI:0.94-1.26). The rate of HT in patients with microbleeds was 3% with dabigatran and 4% with aspirin (OR = 0.85; 95%CI:0.11-6.75). Excellent functional outcome occurred in 74% and 84% of dabigatran and aspirin-treated patients, respectively (RR = 0.88; 95%CI:0.69-1.12). 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.
Insights
Dabigatran is safe for acute ischemic stroke patients with cerebral microbleeds, showing no increased risk of hemorrhagic transformation or reduced functional outcomes compared to aspirin. Microbleed presence did not alter dabigatran
Area of Science:
- Neurology
- Radiology
- Pharmacology
Background:
- Cerebral microbleeds increase hemorrhagic transformation (HT) risk after ischemic stroke.
- The impact of dabigatran versus aspirin on HT in minor stroke patients with microbleeds is unclear.
Purpose of the Study:
- To investigate if baseline cerebral microbleeds modify the effect of dabigatran compared to aspirin in patients with acute minor non-cardioembolic ischemic stroke or transient ischemic attack (TIA).
Main Methods:
- Post hoc analysis of the Dabigatran Treatment of Acute Stroke II trial.
- 251 patients with interpretable baseline MRI for microbleeds were analyzed.
- Multivariable regression assessed the association between microbleeds and HT or excellent functional outcome.
Main Results:
- 33% of patients had microbleeds; 6% developed HT. No association found between microbleeds and HT (aOR=0.84) or excellent functional outcome (aRR=1.09).
- Dabigatran and aspirin showed similar HT rates (3% vs 4%) and excellent functional outcomes (74% vs 84%) in patients with microbleeds.
- Microbleed presence, severity, or location did not modify dabigatran's effect on outcomes (p-interaction > 0.05).
Conclusions:
- Early dabigatran treatment is safe for acute minor ischemic stroke/TIA patients with cerebral microbleeds.
- Dabigatran does not increase hemorrhage risk in patients with hemorrhage-prone cerebral small vessel disease.
