Medical Management and Revascularization for Asymptomatic Carotid Stenosis.
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Brott Thomas G, Howard George, Lal Brajesh K, Voeks Jenifer H, Turan Tanya N, Roubin Gary S, Lazar Ronald M, Brown Robert D, Huston John, Edwards Lloyd J, Jones Michael, Clark Wayne M, Chamorro Ángel, Llull Laura, Mena-Hurtado Carlos, Heck Donald, Marshall Randolph S, Howard Virginia J, Moore Wesley S, Barrett Kevin M, Demaerschalk Bart M, Sangha Navdeep, Aronow Herbert, Foster Malcolm, Sternbergh W Charles, Shawl Fayaz, Lanzino Giuseppe, Rapp Joseph, Tran Hoang S, Ecker Robert, Mackey Ariane, Ali Vaqar, Given Curtis, Teal Philip, Kashyap Vikram S, Mukherjee Dipankar, Harrigan Mark, Silverman Scott, Koopmann Matthew, Wadley Virginia G, Zhang Yu, Rhodes J David, Chaturvedi Seemant, Meschia James F, CREST-2 Investigators
Аннотация
METHODS: We conducted two parallel, observer-blinded clinical trials that enrolled patients with high-grade (≥70%) asymptomatic carotid stenosis across 155 centers in five countries. The stenting trial compared intensive medical management alone (medical-therapy group) with carotid-artery stenting plus intensive medical management (stenting group); the endarterectomy trial compared intensive medical management alone (medical-therapy group) with carotid endarterectomy plus intensive medical management (endarterectomy group). 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.
RESULTS: A total of 1245 patients underwent randomization in the stenting trial and 1240 in the endarterectomy trial. In the stenting trial, the 4-year incidence of primary-outcome events was 6.0% (95% confidence interval [CI], 3.8 to 8.3) in the medical-therapy group and 2.8% (95% CI, 1.5 to 4.3) in the stenting group (P = 0.02 for the absolute difference). In the endarterectomy trial, the 4-year incidence of primary-outcome events was 5.3% (95% CI, 3.3 to 7.4) in the medical-therapy group and 3.7% (95% CI, 2.1 to 5.5) in the endarterectomy group (P = 0.24 for the absolute difference). From day 0 to 44, in the stenting trial, no strokes or deaths occurred in the medical-therapy group and seven strokes and one death occurred in the stenting group; in the endarterectomy trial, three strokes occurred in the medical-therapy group and nine strokes occurred in the endarterectomy group.
CONCLUSIONS: Among patients with high-grade stenosis without recent symptoms, the addition of stenting led to a lower risk of a composite of perioperative stroke or death or ipsilateral stroke within 4 years than intensive medical management alone. Carotid endarterectomy did not lead to a significant benefit. (Funded by the National Institute of Neurological Disorders and Stroke and others; CREST-2 ClinicalTrials.gov number, NCT02089217.).