Observational case-control study of the prevalence of chronic cerebrospinal venousinsufficiency in multiple sclerosis: results from the CoSMo study

Abstract

Background: Chronic cerebrospinal venous insufficiency (CCSVI) has been proposed as a possible cause ofmultiple sclerosis (MS). Objectives: The CoSMo study evaluated the association between CCSVI and MS. Methods: The primary end-point of this multicentric, case-control study was to compare the prevalence ofCCSVI between patients with MS, patients with other neurodegenerative diseases (ONDs) and healthycontrols (HCs). Color-coded duplex sonography was performed by a sonologist and the images were sentto one of three central sonologists for a second reading. Agreement between local and centralsonologists or, in case of disagreement, the predominant judgment among the three central readers,was required for a diagnosis of CCSVI. All readings, data collection and analysis were blinded. Results: The study involved 35 MS centers across Italy and included 1874 subjects aged 18–55. 1767 (94%)were evaluable: 1165 MS patients, 226 patients with ONDs and 376 HCs. CCSVI prevalence was 3.26%,3.10% and 2.13% for the MS, OND and HC groups, respectively. No significant difference in CCSVIprevalence was found amongst the three cohorts (MS versus HC, OR = 1.55, 95%CI = 0.72–3.36,p = 0.30; OND versus HC, OR = 1.47, 95%CI = 0.53–4.11, p = 0.46;MS versus OND, OR = 1.05, 95%CI = 0.47–2.39, p = 0.99). High negative and lowpositive agreement was found between the local and centralized readers. Conclusions: CCSVI is not associated with MS.