Limitations
Our trial has several limitations. The noninferiority margin used in the original trial was not selected using the minimal clinically important difference or fixed margin methods. The noninferior margin of 10% is broad, reaching no consensus in the clinical community, which may lead to concerns about the robustness of study results. Furthermore, the early termination and small sample size of the trial may create potential limitation affecting our findings that the treatment effect observed with endovascular treatment alone at 3 months was sustained at 18 months. Finally, missing data of long-term outcome at 18 months may introduce a substantial risk of bias. However, a sensitivity analysis in which missing outcomes were imputed by means of model-based imputation showed results that were similar to those of the main analysis of the primary outcome, which suggests a limited effect of bias.