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ESCAPE Trial: Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke

Summary:

  • ESCAPE was a well designed prospective, multicenter, clinical trial involving 350 patients with acute ischemic stroke due to a proximal occlusion of the anterior circulation who were randomized to either receive usual care or endovascular therapy (endovascular thrombectomy or thrombolysis) plus usual care. 
  • The primary endpoint was a shift of one or more categories (proportional odds analysis) on the modified Rankin scale.
  • More patients receiving endovascular therapy had a greater degree of independence.  In addition, mortality was reduced from 13% to 6% and the study was terminated early.
  • This is the first randomized control trial to show a mortality benefit from reperfusion for ischemic stroke.

ESCAPE Trial Summary

  • Goyal et al (ESCAPE Trial investigators). Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke. N Engl J Med 2015 Mar 12;372(11):1019-30. PubMed
    Level of Evidence 1b
    Study Design Prospective, Randomized, Open-label, Blinded end-point, Multicenter Trial
    Sample Size N = 315 (this study was terminated early)
    Population Patients with disabling acute stroke due to a proximal intracranial artery occlusion of the anterior circulation with collateral flow to an ischemic penumbra surrounding an ischemic core.
    Inclusion Criteria
    • Acute ischemic stroke
    • Age 18 or greater
    • Onset (last-seen-well) time to randomization time < 12 hours.
    • Disabling stroke defined as a baseline NIHSS > 5 at the time of randomization.
    • Pre-stroke (24 hours prior to stroke onset) independent functional status
    • Confirmed symptomatic intracranial occlusion at the internal carotid artery, proximal middle cerebral artery, distal middle cerebral artery.
    • Time to puncture within 60 minutes of baseline non-contrast CT with target CT to first recanalization of 90 minutes
    Exclusion Criteria
    • Confirmation of a moderate/large core in the territory of symptomatic intracranial occlusion via non contrast CT, CTA or CT perfusion.
    • Groin puncture is not possible within 60 minutes
    • No femoral pulses or very difficult endovascular access
    • Pregnancy
    • Suspected intracranial dissection as a cause of stroke
    • Severe or fatal comorbid illness precluding follow-up or rendering intervention ineffective
    Interventions
    • N = 150; Control Group = Usual acute stroke care per guidelines
    • N = 165; Intervention Group = Endovascular thrombectomy or thrombolysis plus usual care
    Follow Up 90 days
    Primary Endpoint A shift of one or more categories (proportional odds analysis) on the modified Rankin scale.
    Secondary Endpoint

    • NIHSS 0-2
    • Modified Rankin Score of 0-2
    • Mortality at 90 days
    • EQ-5D (EuroQoL) Cognitive outcomes (Trailmaking A, B; MoCA; Boston Naming test; Sunnybrook hemi-spatial neglect battery) Barthel Index > 90 (≥95)
    • Barthel Index shift analysis (ordinal logistic regression) miFUNCTION score
    • Economic (cost-effectiveness) analysis
    Results

    • Median age was 70 years with an NIH stroke scale of 17
    • Time to puncture was approximately 4 hours
    • 53% of patients in the intervention group had a modified Rankin score of 0-2 at 90 days as compared to 29.3% in the control group giving an absolute difference of 23.7%
    • Mortality was reduced from 13% to 6%
    • Retrievable stents were used in 130 of the 151 participants (86%) in the intervention group
    • There were no significant differences in symptomatic intracerebral hemorrhage or perforations of the middle cerebral artery.
    NNT/NNH

    • NNT for good neurologic outcome = 4
    • NNT to save a life = 15
    Conclusions In patients with an acute ischemic stroke due to a proximal vessel occlusion with a small infarct core and moderate to good collateral circulation, intra-arterial intervention as an adjunct to the standard of care improves neurologic status and mortality at 90 days.
    Location 22 centers in Canada, the United States, South Korea, Ireland, and the UK
    Funding Covidien and others
    Comments
    • This is the first randomized control trial to show a mortality benefit from reperfusion for ischemic stroke.
    • A planned interim analysis was accelerated after the MR CLEAN results were published and conducted after 243 patients had completed their 90 day follow up. Early termination of trial recruitment for efficacy was recommended. The trial had originally planned to enroll 500 patients through 90 days of follow up.

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MESH Terms & Keywords

  • tPA Alteplase, Endovascular Treatment of Acute Ischemic Stroke, ESCAPE Trial