In individuals who had embolic stroke of unknown source (ESUS) and carotid atherosclerosis, treatment with aspirin was safer than with rivaroxaban (Xarelto; Janssen Pharmaceuticals, Raritan, NJ) and as effective for prevention of secondary stroke. An exploratory subgroup analysis of outcomes for participants in the NAVIGATE-ESUS trial (NCT02313909). Of those who participated in the trial, 40% had carotid artherosclerosis (defined as carotid stenosis of 20%-49% or presence of carotid stenosis (n = 490) and 11% had carotid stenosis. For those with carotid stenosis, the hazard ratio (HR) for secondary stroke when treated with aspirin was 0.85 (95% CI, 0.39-1.87; P = .78 for interaction of treatment effect with group without carotid stenosis). For those with carotid plaque, the HR was 1.20 (95% CI, 0.86–1.68; P for interaction of treatment effect with patients without carotid stenosis 0.2).
For participants with carotid plaque, major bleeding was more frequent in those treated with rivaroxaban compared with aspirin (HR = 3.75; 95% CI, 1.63–8.65). Although participants with carotid stenosis had a similar rate of secondary ischemic stroke compared with those without (HR = 1.11; 95% CI, 0.73–1.69), there was a strong trend of higher rate of secondary ischemic stroke recurrence in people with carotid plaque vs those without (HR, 1.23; 95% CI, 0.99–1.54).
Carotid plaque was much more often present ipsilateral to the qualifying ischemic stroke than contralateral, supporting an important etiological role of nonstenotic carotid disease in ESUS.
Michelle L. Dougherty, MD, FAAN, FAES
Reginald Lafleur, MD; Melissa Lafleur, MD; Steven Mandel, MD; and Jason A. Ellis, MD
Amber D. Van Laar, MD; and Victor S. Van Laar, PhD