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Comment & Response
May 18, 2021

Functional Outcomes Among Patients With Acute Ischemic Stroke After Mechanical Thrombectomy With or Without Intravenous Thrombolysis—Reply

Author Affiliations
  • 1Department of Neurology, Nippon Medical School, Tokyo, Japan
  • 2Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan
JAMA. 2021;325(19):2020. doi:10.1001/jama.2021.4037

In Reply Dr Mai and colleagues describe some concerns with the SKIP study,1 including the balance of baseline characteristics between the 2 groups, the sample size, and the noninferiority margin for the secondary outcome.

First, patients in our study were randomized to 2 groups using a stratified permuted-block method for each hospital. Although an imbalance did exist between men and women in the study groups, other baseline characteristics, including blood pressure, stroke severity, and stroke location, were not statistically different between the 2 groups. We believe the male/female imbalance was due to chance alone. The odds ratio of noninferiority for the primary outcome was 1.09 (97.5% CI, 0.63 to ∞). In a post hoc analysis, the odds ratio adjusted for male/female sex was 1.11 (97.5% CI, 0.63 to ∞).

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