Abstract
The safety and efficacy of endovascular therapy for large-artery stroke in the extended time window is not yet well-established. We performed a subgroup analysis on subjects enrolled within an extended time window in the Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial. Fifty-nine of 315 subjects (33 in the intervention group and 26 in the control group) were randomized in the ESCAPE trial between 5.5 and 12 hours after last seen healthy (likely to have groin puncture administered 6 hours after that). Treatment effect sizes for all relevant outcomes (90-day mRS shift, mRS 0-2, mRS 0-1, and 24-hour NIHSS scores and intracerebral hemorrhage) were reported using unadjusted and adjusted analyses. There was no evidence of treatment heterogeneity between subjects in the early and late windows. Treatment effect favoring intervention was seen across all clinical outcomes in the extended time window (absolute risk difference of 19.3% for mRS 0-2 at 90 days). There were more asymptomatic intracerebral hemorrhage events within the intervention arm (48.5% versus 11.5%, P = .004) but no difference in symptomatic intracerebral hemorrhage. Patients with an extended time window could potentially benefit from endovascular treatment. Ongoing randomized controlled trials using imaging to identify late presenters with favorable brain physiology will help cement the paradigm of using time windows to select the population for acute imaging and imaging to select individual patients for therapy.
Highlights
BACKGROUND AND PURPOSEThe safety and efficacy of endovascular therapy for large-artery stroke in the extended time window is not yet well-established
Patients with an extended time window could potentially benefit from endovascular treatment
Current guidelines recommend endovascular treatment in patients with ischemic stroke presenting within 6 hours from stroke-symptom onset.[1]
Summary
Fifty-nine of 315 subjects (33 in the intervention group and 26 in the control group) were randomized in the ESCAPE trial between 5.5 and 12 hours after last seen healthy (likely to have groin puncture administered 6 hours after that). Treatment effect sizes for all relevant outcomes (90-day mRS shift, mRS 0 –2, mRS 0 –1, and 24-hour NIHSS scores and intracerebral hemorrhage) were reported using unadjusted and adjusted analyses. The ESCAPE trial was a prospective, multicenter, randomized, controlled, open-label trial design with blinded outcome assessment.[6,7] The trial enrolled. The absolute risk difference favoring intervention was 19.3% on the mRS 0 –2 at 90 days, and the shift analysis (proportional odds model) favored intervention (adjusted common OR ϭ 2.61; patients presenting within 12 hours from last seen healthy with 95% CI, 0.9 –7.8). A higher rate of all types of ICH (including disabling ischemic stroke, a small core infarct on noncontrast petechial hemorrhage) was noted in the intervention arm (Tahead CT (ASPECTS 6 –10), and moderate-to-good collaterals ble 3), but not of symptomatic ICH.
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