Methodological Compromise in the EVIDENCE trial: Why a Non-Significant Result Does Not Mean Equivalence

The EVIDENCE trial compared flow diversion with coiling ± stenting for unruptured wide-neck intracranial aneurysms and reported no significant difference in the primary outcome. This commentary argues that such a result, in an underpowered randomized trial that was terminated early and whose primary hypothesis and endpoint handling were modified during the study, cannot be interpreted as evidence of equivalence. Instead, the findings should be regarded as inconclusive and insufficient to support practice-changing claims about the comparative safety and efficacy of flow diversion versus coiling.