For minor stroke without large vessel occlusion, DAPT was superior to intravenous alteplase in preventing early neurological deterioration (risk difference -4.8%; 95% CI -6.9% to -2.6%; P<0.001).
RCT (n=480)
Does dual antiplatelet therapy reduce early neurological deterioration compared to intravenous alteplase in patients with minor nondisabling acute ischemic stroke without large vessel occlusion?
In patients with minor nondisabling acute ischemic stroke without large vessel occlusion, DAPT may be superior to intravenous alteplase for preventing early neurological deterioration and reducing bleeding events.
Absolute Risk Reduction: 4.8 (95% CI 2.6–6.9)
Absolute Risk Reduction: 4.8%
p-value: p=<0.001
BACKGROUND: Dual antiplatelet therapy (DAPT) was noninferior to alteplase in minor nondisabling strokes in the ARAMIS trial (Antiplatelet Versus R-tPA for Acute Mild Ischemic Stroke); however, early neurological deterioration (END) associated with vessel stenosis may benefit from DAPT. We investigated whether the efficacy of DAPT was greater than alteplase in minor strokes with no large vessel occlusion (LVO). METHODS: This study was a prespecified post hoc analysis of the ARAMIS trial and included patients with responsible vessel examination in the as-treated analysis set of the ARAMIS trial who were divided into LVO group and non-LVO group. In each group, patients were further classified into DAPT and intravenous alteplase treatments. Primary outcome was END at 24 hours defined as more than or equal to 4-point National Institutes of Health Stroke Scale score increase compared with baseline, and safety outcomes were symptomatic intracerebral hemorrhage and bleeding events during study. The primary analysis was estimated with a risk difference calculated by a generalized linear model including adjusted different baseline characteristics between treatments. RESULTS: Of 723 patients from the ARAMIS trial, 480 patients were included: 36 were categorized into LVO group and 444 into non-LVO group, of whom 20 patients had END. Compared with intravenous alteplase, a lower proportion of END was found after DAPT treatment in the non-LVO group (adjusted risk difference, −4.8% 95% CI, −6.9% to −2.6%; P <0.001), but not in the LVO group (adjusted risk difference, 2.3% 95% CI, −17.6% to 22.3%; P =0.82). The interaction was marginally significant between groups ( P =0.06). In the non-LVO group, a lower proportion of bleeding events was found after DAPT treatment than intravenous alteplase (adjusted risk difference, −6.4% 95% CI, −8.9% to −3.9%; P <0.001). Other safety outcomes were similar between the 2 treatments. CONCLUSIONS: Among minor nondisabling acute ischemic stroke without LVO, DAPT may be superior to intravenous alteplase regarding preventing END with a better safety profile. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03661411.
Cui et al. (2024) conducted an RCT in Minor stroke with versus without large vessel occlusion (n=480). Dual antiplatelet therapy (DAPT) vs. Intravenous alteplase was evaluated on Early neurological deterioration (END) at 24 hours (≥4-point NIHSS score increase) (adjusted risk difference -4.8%, 95% CI -6.9% to -2.6%, p=<0.001). For minor stroke without large vessel occlusion, DAPT was superior to intravenous alteplase in preventing early neurological deterioration (risk difference -4.8%; 95% CI -6.9% to -2.6%; P<0.001).