- Risk for another stroke is 51% higher in patients with embolic stroke of undetermined source who have cerebral microbleeds.
- The presence of cerebral microbleeds does not significantly affect rivaroxaban efficacy and safety.
Why this matters
- Editorial: findings should “contribute to changing the mindset of clinicians," and "[c]urrent evidence does not justify avoiding antithrombotic medication" solely because of microbleeds.
- 11% of patients had microbleeds.
- Independent predictors (ORs):
- Advancing age (OR per year): 1.03.
- East Asian ancestry: 1.57.
- Hypertension: 2.20.
- Multiterritorial infarcts: 1.95.
- Chronic infarcts: 1.78.
- Occult intracerebral hemorrhage: 5.23.
- Microbleeds increased HRs (95% CIs) for:
- Recurrent stroke: 1.51 (1.02-2.25).
- Intracerebral hemorrhage: 4.18 (1.26-13.90).
- All-cause mortality: 2.13 (1.06-4.26).
- Lobar microbleeds specifically increased risk for ischemic stroke: HR, 2.33 (95% CI, 1.26-4.30).
- No significant interactions between microbleeds and treatment (rivaroxaban vs aspirin) for recurrent stroke, ischemic stroke, or all-cause mortality risks.
- Intracerebral hemorrhage risk on rivaroxaban was similar with (HR, 3.12) and without microbleeds (HR, 2.96; interaction P>.99).
- Subgroup analyses of international, phase 3, randomized clinical trial comparing rivaroxaban vs aspirin in patients aged ≥50 years with embolic stroke of undetermined source (NAVIGATE ESUS).
- 3699 patients (51%) had information on cerebral microbleeds reported on baseline MRI.
- Main outcome: recurrent stroke over a median 11 months.
- Funding: Bayer AG; Janssen Research and Development LLC.
- Possible selection bias, misclassification.
- Lack of power to assess associations of microbleed burden, topography with outcomes.