Best medical management versus intravenous thrombolysis for mild non-disabling ischemic stroke: A prospective noninferiority registry study

Abstract

ObjectivesThe efficacy and safety of intravenous thrombolysis uncertain in patients with non-disabling mild ischemic stroke. Our aim was to investigate whether best medical management only is noninferior to intravenous thrombolysis plus best medical management therapy for achieving favorable functional outcome at 90 days. Materials and methodsIn a prospective acute ischemic stroke registry from 2018 through 2020, 314 non-disabling mild ischemic stroke patients received best medical management only and 638 underwent intravenous thrombolysis plus best medical management. The primary outcome was modified Rankin Scale ≤1 at Day 90. The noninferiority margin was −5%. Secondary outcomes of hemorrhagic transformation, early neurologic deterioration and mortality were also evaluated. ResultsThe best medical management only was noninferior to the combined therapy of intravenous thrombolysis and best medical management with regard to the primary outcome (unadjusted risk difference, 1.16%; 95% CI, −3.48% ∼ 5.8%; p = 0.0046 for noninferiority; adjusted risk difference, 3.01%; 95% CI, −3.39% ∼ 9.41%). After propensity score matching, p < 0.0001 for noninferiority. RD, 4.03%; 95% CI, −1.59% ∼ 9.69%. p < 0.0001 for noninferiority. Adjusted RD, 5.23%; 95% CI, −1.88% ∼ 9.97%. The occurrence of hemorrhagic transformation was significantly increased in the group of combination therapy (OR, 4.26; 95% CI, 1.30 to 13.99; p = 0.008), while no significant difference was detected in early neurologic deterioration (OR, 1.11; 95% CI, 0.49–2.52; p = 0.808) and mortality (OR, 0.57; 95% CI, 0.20 to 1.69; p = 0.214) between groups. ConclusionsIn the present study, we found the best medical management only was noninferior to the combination therapy of intravenous thrombolysis plus best medical management for non-disabling mild ischemic stroke within 4.5 h after onset. Best medical management may be a treatment of choice for non-disabling mild ischemic stroke patients. Further randomized controlled studies are warranted.