CREST Published in NEJM

May 26, 2010—Thomas G. Brott, MD, et al published the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial) study results online ahead of print in the New England Journal of Medicine. The data were presented for the first time on February 26 at the International Stroke Conference 2010 in San Antonio, Texas and were reported at that time by Endovascular Today (2010;9:12–16).

As detailed in the New England Journal of Medicine, the CREST study randomly assigned patients with symptomatic or asymptomatic carotid stenosis to undergo carotid artery stenting (CAS) or carotid endarterectomy (CEA). The primary composite endpoint was stroke, myocardial infarction (MI), or death from any cause during the periprocedural period or any ipsilateral stroke within 4 years after randomization.

The CREST investigators concluded, “Among patients with symptomatic or asymptomatic carotid stenosis, the risk of the composite primary outcome of stroke, MI, or death did not differ significantly in the group undergoing CAS and the group undergoing CEA. During the periprocedural period, there was a higher risk of stroke with stenting and a higher risk of MI with endarterectomy.”

The investigators reported that for 2,502 patients over a median follow-up period of 2.5 years, there was no significant difference in the estimated 4-year rates of the primary composite endpoint between the CAS group and the CEA group (7.2% vs 6.8%; hazard ratio with stenting, 1.11; 95% confidence interval, 0.81–1.51; P = .51). There was no differential treatment effect with regard to the primary endpoint according to symptomatic status (P = .84) or sex (P = .34).

For CAS and CEA, the 4-year rate of stroke or death was 6.4% and 4.7% (hazard ratio, 1.5; P = .03), the rates among symptomatic patients were 8% and 6.4% (hazard ratio, 1.37; P = .14), and the rates among asymptomatic patients were 4.5% and 2.7% (hazard ratio, 1.86; P = .07), respectively. Periprocedural rates of individual components of the endpoints differed between the CAS group and the CEA group for death (0.7% vs 0.3%; P = .18), stroke (4.1% vs 2.3%; P = .01), and MI (1.1% vs 2.3%; P = .03). After this period, the incidences of ipsilateral stroke with CAS and with CEA were similarly low (2% vs 2.4%; P = .85).

In an accompanying editorial published online ahead of print in the New England Journal of Medicine, Stephen M. Davis, MD, and Geoffrey A. Donnan, MD, concluded that given the lack of significant difference in the rate of longterm outcomes, the individualization of treatment choices is appropriate. They advised that more long-term data are needed before a full appreciation of the relative risks and benefits of CAS and CEA can be made. The risk-benefit issue is complex and should be discussed with patients.

Abbott Vascular (Santa Clara, CA) announced that based on the strength of data from the CREST study, which used the company's Acculink carotid stent system and Accunet embolic protection system, the company will seek an expanded indication from the US Food and Drug Administration (FDA) for the Acculink as a treatment option for patients at standard surgical risk. Abbott will also seek coverage from the Centers for Medicare & Medicaid Services for standard-risk patients if the FDA approves the treatment for this broader patient group. The company will submit the results of a previously agreed upon analysis of the CREST data to the FDA by the end of the year. All carotid stent systems in the United States are currently indicated only for high-surgical-risk patients, the company noted.

In addition, the Society for Cardiovascular Angiography and Interventions (SCAI) stated that the results from CREST should convince the CMS to reopen its coverage decision to give carotid artery stenosis patients the opportunity to receive CAS and allow physicians to tailor treatments for the best possible outcome. The evidence now strongly supports individualizing treatment and offering stent coverage so that more patients who may benefit from this safe, effective, and less-invasive treatment can have access to it, SCAI stated.