Long-Term Observational Extension Study of an International Stroke Prevention Clinical Trial: Methods and Opportunities.

Abstract

Introduction: The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2) randomized clinical trial compares the efficacy of revascularization plus intensive medical management (IMM) versus IMM alone for stroke prevention in patients with high-grade asymptomatic carotid stenosis. Innovative strategies are needed to extend clinical follow-up and assess long-term durability of both revascularization and intensive medical therapy. This manuscript describes the methods and early experiences of the Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE).

Methods: C2LOE will extend follow-up in CREST-2 participants for up to 10 years. Patients undergo a scripted, computer-assisted telephone interview every 6 months focused on screening for potential stroke events and any hospitalizations and performing a brief cognitive assessment. If a stroke or transient ischemic attack (TIA) is suspected, or a hospitalization is reported, medical records are retrieved, and vascular neurology video visit assessments are conducted to be used for central adjudication of potential endpoints.

Conclusion: We describe an ongoing posttrial follow-up study of stroke prevention following IMM with or without carotid revascularization. The study relies on screening for stroke endpoints through periodic telephonic interviews and validation of endpoints through medical record review and vascular neurology video visits. We demonstrate that this technique can be applied effectively to patients enrolled across more than 50 centers. Further research is needed to determine the optimal approach for long-term follow-up studies in stroke-relevant populations.