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

Year: 2025

Type: article

Abstract: 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.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.17714557

Authors: Albiña-Palmarola, Pablo, Henkes, Hans

Institutions: Klinikum Stuttgart, University of Duisburg-Essen

Language: English

Topic: Intracranial Aneurysms: Treatment and Complications

Subfield: Neurology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W7106714221

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