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- Table 1
RCTs to compare CEA and CAS for carotid stenosis
Trial Study population Follow-up Primary endpoint Results WALLSTENT56 Symptomatic stenosis of 60%–99%
(n=219)24 hours;
1, 6, 12 monthsIpsilateral stroke, or death within 1 year CAS with significantly higher primary endpoint (12.1% vs 3.6%, p=0.022)
No significant difference in any major stroke at 1 year (3.7% vs 0.9%, p=0.204)
CAS with significantly higher complication rates at 30 days (12.1% vs 4.5%, p=0.049)CAVATAS43 55 Carotid stenosis equally suitable for CAS and CEA
(n=504)Median 5 years Any stroke or death No significant difference for disabling stroke or death within 30 days (6.4% vs 5.9%)
CAS with significantly more severe restenosis after 1-y (14% vs 4%, p<0.001)
CAS with higher 8-y rate of ipsilateral (11.3% vs 8.6%) & any stroke (21.1% vs 15.4%)SAPPHIRE46 47 Symptomatic: >50%;
Asymptomatic: >80%;
(n=334)30 days; 1, 2, 3 years Death, stroke, or MI within 30 days; death or ipsilateral stroke beyond 30 days Lower primary endpoint with CAS (12.2% vs 20.1%) (p=0.053)
Less carotid revascularisation with CAS at 1 year (0.6% vs 4.3%, p=0.04)
No significant difference in outcome at 3 years (24.6% vs 26.9%)EVA-3S50 51 Symptomatic carotid stenosis of ≥60%
(n=527)Median 7.1 years Composite of any stroke or death within 30 days Significantly higher rate of any stroke or death with CAS within 30 days (9.6% vs 3.9%), at 6 months (11.7% vs 6.1%), and 5 years (11.0% vs 6.3%)
No significant difference in any stroke or death at 10 years (11.5% vs 7.6%, p=0.07)SPACE48 49 Symptomatic severe carotid stenosis
(n=1200)1, 7, 30 days; 6, 12, 24 months ipsilateral ischaemic stroke or death within 30 days Primary endpoint: CAS 6.84% vs CEA 6.34% (p=0.09 for non-inferiority)
No significant difference in ipsilateral ischaemic stroke and periprocedural stroke or death at 2 years (CAS 9.5% vs CEA 8.8%)
Significantly higher rate of restenosis with CAS (10.4% vs 4.6%, p=0.009)CREST44 45 Symptomatic:
>50% on angiography,
>70% on CTA, MRA or US
Asymptomatic:
>60% on angiography,
>70% on US,
>80% on CTA or MRA
(n=2502)Median 2.5 years; 10 years composite of stroke, MI or death during periprocedural period or ipsilateral stroke within 4 years after randomisation No significant difference in primary endpoint: CAS 7.2% vs CEA 6.8% (p=0.51)
Similar in periprocedural death: CAS 0.7% vs CEA 0.3% (p=0.18)
Significantly more periprocedural stroke in CAS (4.1% vs 2.3%, p=0.01)
Significantly more MI in CEA (2.3% vs 1.1%, p=0.03);
No significant difference in primary endpoint at 10 years (CEA 9.9% vs CAS 11.8%)
No significant difference in postprocedural stroke at 10 years (CEA 5.6% vs CAS 6.9%)ICSS52 53 Symptomatic carotid stenosis of more than 50%
(n=1713)Median 4.2 years 3 year rate of fatal or disabling stroke in any territory No significant difference in disabling stroke or death at 120 days (4.0% vs 3.2%)
Higher incidence of stroke, death or procedural MI with CAS at 120 days (8.5% vs 5.2%, p=0.006)
Higher risk of stroke (HR, 1.92) and all-cause death (HR, 2.76) with CAS at 120 days
Similar 5 year risk of fatal or disabling stroke (6.4% vs 6.5%)
Higher rate of any stroke at 5 years with CAS (15.2% vs 9.4%, p<0.001)
No significant difference in mRS at 1 year, 5 years and final follow-upACT-154 Asymptomatic severe carotid stenosis
(n=1453)5 years Composite of death, stroke, or MI within 30 days or ipsilateral stroke within 1 year No significant difference in primary endpoint (3.8% vs 3.4%)
No significant difference in stroke or death within 30 days (2.9% vs 1.7%, p=0.33)
No significant difference in ipsilateral stroke (2.2% vs 2.7%, p=0.51) and overall survival rate (87.1% vs 89.4%, p=0.21) from 30 days to 5 years
Similar cumulative 5 year rate of stroke-free survival (93.1% vs 94.7%, p=0.44)CAS, carotid artery stenting; CEA, carotid endarterectomy; CTA, CT angiography; MI, myocardial infarction;MRA, magnetic resonance angiography; mRS, modified Rankin Scale; RCT, randomised controlled trial; US, ultrasonography.
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