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CAS provides long-term stroke prevention in real-world population
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In a real-world setting, carotid artery stenting appears to achieve long-term stroke prevention in patients treated at experienced, high-volume centers, according to recent findings.
In the all-comers registry with a stringent, prospectively designed follow-up protocol, researchers evaluated 1,000 consecutive carotid artery stenting (CAS) procedures performed in 901 patients at a single center between November 1999 and March 2015. Patients underwent the procedure for symptomatic (29.1%; n = 262) or asymptomatic carotid artery stenosis. The mean age of the patients was 71 years, with 36.1% aged at least 75 years and 17.5% aged at least 80 years. Of these real-world patients, 32.1% would have been excluded from the CREST trial, whereas 40.5% would have been included in the SAPHHIRE trial of patients at high risk for endarterectomy.
According to the researchers, all patients underwent extensive neurological evaluation by an independent neurologist within 24 hours before and after the procedure.
Patients were seen for routine follow-up on day 30 after stent implantation through telephone interviews and filled out written standardized questionnaires on an annual basis thereafter. The mean follow-up was 5.5 years, with 114 patients (13%) reaching 10-year follow-up, according to the researchers.
The study’s primary endpoint was 30-day composite of death, any stroke or MI (MACCE), as well as long-term (beyond 30-day follow-up) ipsilateral stroke. The secondary endpoint was defined as the composite of any periprocedural stroke, as well as long-term (beyond 30 days) ipsilateral stroke.
The researchers reported that procedural success was attained in 98.1% of the cases.
At 30 days, the rate of MACCE was 5% and showed a trend toward higher risk for MACCE among patients with symptomatic carotid artery stenosis vs. asymptomatic patients (7.7% vs. 4%; P = .06).
Additionally, the risk for the composite of death and major stroke was higher among the asymptomatic patients (5.6%) vs. asymptomatic patients (1.7%; P = .001), and symptomatic patients also faced a higher risk for major stroke alone (3.7% vs. 0.8%; P = .008).
According to the researchers, the risk for 30-day MACCE among those who met CREST inclusion criteria was 4.3% in symptomatic patients and 3.6% in asymptomatic patients. Patients eligible as high-risk participants in SAPHHIRE also had a higher risk for 30-day MACCE (7% vs. 3.8%; P = .021).
The Kaplan-Meier estimated 10-year rate of the primary endpoint was 6.9%, and the rate of the stroke endpoint was 5.6%. After the 30-day follow-up, eight patients (1.1%) experienced ipsilateral stroke, resulting in an 0.6% annual ipsilateral stroke risk (0.8% in symptomatic patients and 0.5% in asymptomatic patients), including the periprocedural interval, according to the researchers. A higher rate of the primary endpoint was seen in symptomatic patients vs. asymptomatic patients (9.9% in symptomatic vs. 5.7% in asymptomatic patients; P = .03). No significant difference was seen between symptomatic and asymptomatic patients regarding the stroke outcome.
Patients who would not have been eligible for CREST had increased risk for both the primary endpoint (11.4% vs. 4.9%; P = .001) and the stroke endpoint (8.6% vs. 4.2%; P = .02). Patients deemed at high risk for carotid endarterectomy in the SAPHHIRE trial had a higher estimated risk for the primary endpoint (9.4% vs. 5.4%; log-rank P = .047), but the difference was not significant for the stroke endpoint, according to the researchers.
“The risk profile of patients in daily clinical practice differs from that in randomized controlled trials and has a strong impact on the outcome after CAS,” the researchers wrote. “Therefore, patient characteristics — particularly age, diabetes, and CREST eligibility — need to be considered before any CAS procedure is performed.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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