CREST Analysis Breaks Down Results in Symptomatic, Asymptomatic Patients

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Regardless of symptomatic status, patients with carotid artery disease have comparable outcomes with stenting or surgery, according to a new subanalysis from the CREST trial published online February 9, 2011, ahead of print in Stroke.

The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), originally published in the July 1, 2010, issue of the New England Journal of Medicine (Brott TG, et al. N Engl J Med. 2010;363:11-23), randomized 2,502 patients with either symptomatic or asymptomatic disease to undergo carotid endarterectomy (CEA) or carotid artery stenting (CAS). Overall, the trial found no significant difference in the estimated 4-year rates of the primary endpoint (composite of any periprocedural stroke, MI, or death, or the incidence of ipsilateral stroke ≤ 4 years) between the 2 groups. However, there was a higher risk of stroke with stenting and a higher risk of MI with surgery.

For the new subanalysis, CREST researchers led by Thomas G. Brott, MD, of the Mayo Clinic (Jacksonville, FL), compared periprocedural complications of CEA and CAS by symptomatic status.

Primary Endpoints Comparable

For the entire cohort, the periprocedural primary endpoint (stroke, MI, or death) was similar for CAS and CEA at 5.2% and 4.5%, respectively (HR 1.18; 95% CI 0.82-1.68 (P = 0.38).

Looking separately at symptomatic and asymptomatic patients, there also was no difference in the primary composite endpoint between the 2 procedures. Periprocedural stroke or death occurred more often with stenting vs. surgery in symptomatic patients but not in asymptomatic patients. MI was more common after surgery in both subgroups, but the trends did not reach statistical significance (tables 1 and 2).

Table 1. Symptomatic Patients: Periprocedural Outcomes

 

CAS
(n = 668)

CEA
(n = 653)

HR (95% CI)

P Value

Primary Endpoint

6.7%

5.4%

1.26 (0.81-1.96)

0.30

Stroke and/or Death

6.0%

3.2%

1.89 (1.11-3.21)

0.019

MI

1.0%

2.3%

0.45 (0.18-1.11)

0.083


Table 2. Asymptomatic Patients: Periprocedural Outcomes

 

CAS
(n = 594)

CEA
(n = 587)

HR (95% CI)

P Value

Primary Endpoint

3.5%

3.6%

1.02 (0.55-1.86)

0.96

Stroke and/or Death

2.5%

1.4%

1.88 (0.79-4.42)

0.15

MI

1.2%

2.2%

0.55 (0.22-1.38)

0.20


For CEA, the primary complications were neck hematomas (1.5%), surgical wound complications (1.6%), and cranial nerve palsies (4.7%), while femoral bleeding events and nonhemorrhagic femoral complications were higher in CAS patients. There were no differences in complication rates between symptomatic and asymptomatic patients.

Despite Similar Results, Surgery Best in Symptomatic

According to Dr. Brott and colleagues, the results of the subanalysis demonstrate the comparative safety of the 2 approaches. They also represent the lowest reported periprocedural stroke and death rates for CAS and CEA from population-based studies or from large randomized trials.

Of clinical interest, however, is the finding that surgery offered a significant reduction in the likelihood of stroke or death only in the symptomatic population, they note.

Quieting the ‘Elephant in the Room’

In a telephone interview with TCTMD, Christopher J. White, MD, of the Ochsner Heart and Vascular Institute (New Orleans, LA), said the new study is important when you consider that asymptomatic patients account for 70% to 80% of all carotid interventions.

“Everyone talks about the symptomatic patients, but the real ‘elephant in the room’ has been these asymptomatic patients,” Dr. White said. “This paper puts to rest the idea that there is any difference between symptomatic and asymptomatic patients with regard to carotid stenting and surgery.” Moreover, it bolsters the original CREST findings by nearly replicating the trial’s primary endpoint rates, he added.

As to the authors’ suggestion that death and stroke rates in the symptomatic group favor surgery, Dr. White strongly disagreed.

“There was no difference in major strokes. The difference was in minor strokes. Why would you take out MI and say that the data favor surgery when surgery causes more MI?” he commented. “If we take out minor strokes, then stenting is better than surgery. It’s a little unfair to cherry pick your endpoint.”

The new analysis also provides more support for clinicians who disagree with recently published guidelines regarding the use of stenting in asymptomatic patients, Dr. White said, asserting, “I think these data really move asymptomatic patients up to a level I rather than a level IIb, so that’s big.”

Study Details

Symptomatic patients were required to have ≥ 50% ipsilateral carotid stenosis by angiography, ≥ 70% by duplex ultrasound, or ≥ 70% by computed tomographic (CT) angiography or magnetic resonance (MR) angiography if the stenosis on ultrasound was 50% to 69%. Asymptomatic patients had to have ≥ 60% stenosis by angiography, ≥ 70% by ultrasound, or ≥ 80% by CT angiography or MR angiography if the stenosis on ultrasound was 50% to 69%. Symptomatic patients had experienced transient ischemic attack or ischemic stroke ipsilateral to a stenosed carotid artery within 180 days of randomization.

 


Source:
Silver FL, Mackey A, Clark WM, et al. Safety of stenting and endarterectomy by symptomatic status in the carotid revascularization endarterectomy versus stenting trial (CREST). Stroke. 2011;Epub ahead of print.

 

 

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Disclosures
  • The study was supported by the National Institute of Neurological Disorders and Stroke and the National Institutes of Health, with supplemental funding from Abbott Vascular.
  • Dr. Brott reports having received honoraria from Sahs Memorial Lecture University of Iowa, American Academy of Neurology 62nd Annual Meeting, Heritage Valley Health System, American Society of Neuroradiology 48th Annual Meeting, Massachusetts General Hospital, and Pennsylvania Advances in Stroke.
  • Dr. White reports having served as principal investigator of the CABANA study, which was sponsored by Boston Scientific.

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