Trial | Study population | Follow-up | Primary endpoint | Results |
WALLSTENT56 | Symptomatic stenosis of 60%–99% (n=219) | 24 hours; 1, 6, 12 months | Ipsilateral 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-up |
ACT-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.