The CREST-2 study aimed to assess whether adding revascularization (either with carotid-artery stenting or endarterectomy) to intensive medical management resulted in better outcomes as compared with intensive medical management alone, in patients with high-grade asymptomatic carotid stenosis. The study was designed as a two parallel observer-blinded trials, each randomizing patients to either medical therapy alone or revascularisation (1245 for stenting and 1240 for endarterectomy). Inclusion criteria were carotid stenosis ≥70% and no recent history of stroke, transient ischemic attack (TIA) or amaurosis fugax in the carotid-artery territory. Each cohort presented similar demographic and risk-factor profiles. Notably, patients with history of atrial fibrillation (AF) prompting anticoagulation were excluded. The primary outcome was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke, assessed during the remaining follow-up period up to 4 years.
In the stenting trial, revascularisation significantly lowered the incidence of the primary outcome (2.8% in stenting vs 6.0% in medical therapy), whereas the endarterectomy trial showed no significant difference (3.7% vs 5.3%). Furthermore, low rates of disabling stroke were observed across all treatment groups, reinforcing the data of other recent interventional trials such as SPACE-2 and ECST-2.
The CREST-2 study challenges prior paradigms in the management of asymptomatic carotid-artery stenosis, as it constitutes the first randomized trial to present evidence in support of carotid-artery stenting over intensive medical management alone, reinforcing its role as a treatment option in this group of patients."