Stenting versus medical therapy alone for symptomatic intracranial arterial stenosis: protocol for a systematic review and individual patient data meta-analysis

INTRODUCTION: Intracranial atherosclerotic stenosis (ICAS) is a common cause of stroke worldwide. However, whether the treatment options for symptomatic ICAS is stent placement or medical therapy alone is still controversial. At present, three multicentre randomised controlled trials (RCTs) have been published, but their research designs are also slightly different and the conclusions are not completely consistent. Therefore, we plan to conduct a systematic review and individual patient data (IPD) meta-analysis of randomised clinical trials to ascertain safety and efficacy of stenting versus medical therapy alone for symptomatic patients with intracranial arterial stenosis. METHODS AND ANALYSES: We will identify RCTs comparing stenting vs medical therapy alone in patients with symptomatic ICAS stenosis (70%–99%) through a systematic search, mainly including PubMed, MEDLINE, EMBASE, the Cochrane Library and ClinicalTrials.gov. Individual-level patient data for a prespecified list of variables will be sought from authors of all eligible studies. The primary outcome was a composite of stroke or death within 30 days, or stroke in territory of qualifying artery beyond 30 days after randomisation. IPD meta-analysis will be conducted with a one-stage approach. ETHICS AND DISSEMINATION: Ethical approval and individual patient consent will not be required in most cases since this IPD meta-analysis will use pseudoanonymised data from RCTs. Results will be disseminated through peer-reviewed journals and international conferences. PROSPERO REGISTRATION NUMBER: CRD42022369922.