CREST: Low Stroke Rate at 10 Years With Both Carotid Stenting and Surgery

February 19, 2016

LOS ANGELES — Results from 10 years' follow-up in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) trial comparing carotid stenting and endarterectomy show low postprocedural rates of stroke (less than 0.7% annually) and other events in both groups, with no difference between symptomatic and asymptomatic patients.

The primary composite endpoint (stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke) and the primary long-term endpoint (postprocedural ipsilateral stroke) were not significantly different between the stent or surgery group at 10 years.

However, the risk for periprocedural stroke or death and subsequent ipsilateral stroke was still significantly higher in the stenting group, driven by the greater number of periprocedural strokes following stenting.

Presenting the 10-year results here at the International Stroke Conference (ISC) 2016, Thomas G. Brott, MD, Mayo Clinic, Jacksonville, Florida, described carotid stenting as "just about as good as surgery," with the current results showing both options were "safe and durable."

Dr Thomas G. Brott

The results were also published online in the New England Journal of Medicine (NEJM) to coincide with the ISC presentation.

"Impressive Durability"

Commenting for Medscape Medial News, Mark Alberts, MD, University of Texas Southwestern Medical Center, Dallas, said: "The trial shows impressive durability with both approaches over a 10-year follow-up. This opens the door for informed discussion between doctor and patient about both options. Yes, there is still the up-front stroke risk with stenting. But if this wasn't there stenting would win very time."

Dr Mark Alberts

The CREST trial randomly assigned 2502 patients with at least 70% carotid stenosis (both symptomatic and asymptomatic patients included) to stenting or endarterectomy. Main results were reported in 2010 and showed similar net outcomes with the two procedures but a higher periprocedural stroke rate in the stenting group. The current presentation addresses results out to 10 years in 1607 patients who consented to long-term follow-up.

These findings showed a postprocedural stroke rate of 6.9% in the stenting group vs 5.6% in the surgery group, a non-significant difference (P = .96). The primary composite endpoint occurred in 11.8% of the stent group vs 9.9%, again a nonsignificant difference (P = .51).

However, the composite of stroke and death (including the periprocedural period) was significantly higher still at 10 years in the stenting group (11.0% vs 7.9%; hazard ratio, 1.37; P = .04).

In the NEJM paper, the authors state that the long-term results of CREST may help guide the treatment of patients with carotid artery disease. They say reducing periprocedural risk with both stenting and endarterectomy should be emphasized. Although in the case of stenting more than half the ipsilateral strokes during a 10-year period occurred within the first month, they point out that with experienced interventionalists and surgeons with verifiable outcomes, who were included in CREST, the rates of periprocedural complications were relatively low with both groups.

They add that: "Decision making is more challenging at centers where interventional and surgical experience cannot be verified."

Dr Alberts agreed that the CREST results "probably wouldn't be replicated by your local community physician," and he recommended that patients should check out individual hospital complication rates as part of the decision-making process.

Dr Brott highlighted the impressively low postprocedural stroke rates out to 10 years in both groups in the trial. "These are on a par with what is expected in the general population," he said.

In contrast, he noted that the North American Symptomatic Carotid Endarterectomy trial had shown a postprocedural stroke rate of 22% at 5 years and the Asymptomatic Carotid Surgery trial showed a rate of 17% at 10 years. But Dr Brott said it is not known whether the impressive long-term complication rate in CREST was actually due to the procedures or to the medical treatment, which has improved greatly in recent years.

He said the trials showing surgery was better than medical therapy were done in the 1980s, "when we would have had ashtrays in this room. Things have moved on a lot since then."

Editorial: Stenting "Potentially Harmful"

In an editorial accompanying the publication, J. David Spence, MD, Western University, London, Ontario, Canada, and A. Ross Naylor, MD, Leicester Royal Infirmary, United Kingdom, say that there is now almost unanimous consensus that after the periprocedural period the rates of late ipsilateral stroke do not differ significantly with carotid stenting or endarterectomy. They add that the long-term CREST results and the Carotid Revascularization Endarterectomy versus Stenting Trial (ACT) 1 trial, presented this week here at the ISC meeting and also published in the New England Journal of Medicine, should dispel any lingering concerns about the durability of stenting.

But the editorialists restate that these trials do not resolve the issue of generalizability of these findings into routine clinical practice, where rates of death and stroke are much higher among patients undergoing carotid stenting.

They caution that there is a danger that the data from CREST and ACT 1 will be interpreted as stenting being equivalent to surgery, further exacerbating the problem. They note that 90% of carotid stenting procedures are carried out in asymptomatic patients, even though most may be unnecessary and "potentially harmful."

Given the low rates of complications now being seen with intensive medical therapy in these patients, the editorialists advise that stenting should be reserved for symptomatic patients and the few asymptomatic patients at particularly high risk (who can be identified with information on microemboli on transcranial Doppler imaging).

They remind that this issue will hopefully be settled by the CREST 2 trial, which is comparing the two interventional strategies with intensive medical therapy alone.

The CREST trial was supported by a grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health and by Abbott Vascular Solutions. Dr Brott reports grant support from the National Institute of Neurological Disorders and Stroke during the conduct of the study.

N Engl J Med. Published online February 18, 2016. Abstract Editorial

International Stroke Conference (ISC) 2016. Abstract LB10. Presented February 18, 2016.

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