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Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct

New England Journal of Medicine Nov 16, 2017

Nogueira RG, et al. - Researchers compared endovascular thrombectomy plus standard medical care with standard medical care alone for the treatment of patients with acute stroke who had last been known to be well 6 to 24 hours earlier and who had a mismatch between clinical deficit and infarct. Compared to standard care alone, outcomes for disability at 90 days were better with thrombectomy plus standard care among these patients.

Methods

  • Patients with occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 hours earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume, with mismatch criteria defined according to age (<80 years or ≥80 years) were enrolled.
  • The researchers randomly assigned patients to thrombectomy plus standard care (the thrombectomy group) or to standard care alone (the control group).
  • The mean score for disability on the utility-weighted modified Rankin scale (which ranges from 0 [death] to 10 [no symptoms or disability]) and the rate of functional independence (a score of 0, 1, or 2 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days were the coprimary end points.

Results

  • The researchers enrolled 206 patients.
  • They assigned 107 to the thrombectomy group and 99 to the control group.
  • They stopped enrollment in the trial because of the results of a prespecified interim analysis at 31 months.
  • At 90 days, the mean score on the utility-weighted modified Rankin scale was 5.5 in the thrombectomy group as compared with 3.4 in the control group (adjusted difference [Bayesian analysis], 2.0 points; 95% credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999), and the rate of functional independence at 90 days was 49% in the thrombectomy group as compared with 13% in the control group (adjusted difference, 33% points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999).
  • Between the 2 groups, the rate of symptomatic intracranial hemorrhage did not differ significantly (6% in the thrombectomy group and 3% in the control group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00).

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