Carotid stenting (CAS) has been mainly offered to those patients considered at “high
risk” for open carotid endarterectomy based on available data from large randomized
clinical trials. However, several recent studies have called medical “high risk” into
question for CAS indication. The REAL-1 trial evaluated the safety and perioperative
and long-term effectiveness in patients with significant carotid artery stenosis with
“high-risk” criteria treated with CAS and proximal protection device (MOMA) compared
with those with standard surgical-risk features. This nonrandomized double-arm registry
included 125 patients (40% symptomatic), 71 (56%) with “standard-risk” and 54 (44%)
with “high-risk” criteria. The primary end point was the cumulative incidence of any
major adverse event, a composite of stroke, myocardial infarction, and death within
30 days after the intervention or ipsilateral stroke after 30 days and up to 4 years.
There was no significant difference in primary end point rate at 30 days between patients
at “standard risk” and those with “high risk” (1.4% vs 1.9% respectively; hazard ratio
for “standard risk” 1.1; 95% CI 0.8 to 1.2, p = 0.77) nor estimated 4-year rate of
ipsilateral stroke (1.3% vs 1.8%; hazard ratio for “standard risk” 1.05, 95% CI 0.86
to 1.14, p = 0.9). In conclusion, 4-year postprocedure results demonstrated that CAS
with proximal device (MOMA) is safe and effective for patients with and without “high-risk”
for carotid endarterectomy.
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Article Info
Publication History
Published online: April 26, 2017
Accepted:
April 13,
2017
Received in revised form:
April 13,
2017
Received:
February 8,
2017
Footnotes
See page 325 for disclosure information.
Identification
Copyright
© 2017 Elsevier Inc. All rights reserved.
