A randomized trial of intraarterial treatment for acute ischemic stroke

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  • P.S.S. F
  • D. B
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Background In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. Methods We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). Results We enrolled 500 patients at 16 medical centers in the Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. Conclusions In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe.

Author-supplied keywords

  • Barthel index
  • ISRCTN10888758
  • National Institutes of Health Stroke Scale
  • Rankin scale
  • adult
  • adverse outcome
  • aged
  • allergic reaction
  • alteplase
  • artery catheterization
  • article
  • blood clot lysis
  • blood clot retraction
  • brain hematoma
  • brain hemorrhage
  • brain infarction size
  • brain ischemia
  • carotid artery stenting
  • cerebral revascularization
  • clinical effectiveness
  • computed tomographic angiography
  • controlled study
  • crossover procedure
  • digital subtraction angiography
  • disease course
  • double blind procedure
  • drug efficacy
  • drug safety
  • embolectomy system
  • emergency treatment
  • female
  • functional status
  • heart muscle ischemia
  • human
  • intention to treat analysis
  • intervention study
  • intraarterial drug administration
  • magnetic resonance angiography
  • major clinical study
  • male
  • mechanical thrombectomy
  • microcatheter
  • multicenter study
  • neuroimaging
  • occlusive cerebrovascular disease
  • outcome assessment
  • patient safety
  • phase 3 clinical trial
  • pneumonia
  • prognosis
  • quality of life
  • quality of life index
  • randomized controlled trial
  • reperfusion
  • scoring system
  • self report
  • subarachnoid hemorrhage
  • symptomatology
  • thromboembolism
  • thrombus aspiration
  • urokinase
  • very elderly

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  • Berkhemer O.A.

  • Fransen P.S.S.

  • Beumer D.

  • Van Den Berg L.A.

  • Lingsma H.F.

  • Yoo A.J.

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