One review author selected trials for inclusion, assessed trial quality and extracted data. A second review author independently validated trial selection and a third review author independently validated data extraction. We calculated treatment effects as odds ratios (OR) and 95% confidence intervals (CI), with endovascular treatment as the reference group. We quantified heterogeneity using the I(2) statistic.
MAIN RESULTS: We included 16 trials involving 7572 patients. In patients with symptomatic
carotid stenosis at standard surgical risk, endovascular treatment was associated with a higher risk of the following outcome measures occurring between randomisation and 30 days
after treatment than
endarterectomy: death or any
stroke (the primary safety outcome) (OR 1.72, 95% CI 1.29 to 2.31, P = 0.0003; I(2) = 27%), death or any
stroke or
myocardial infarction (OR 1.44, 95% CI 1.15 to 1.80, P = 0.002; I(2) = 7%), and any
stroke (OR 1.81, 95% CI 1.40 to 2.34, P < 0.00001;I(2) = 12%). The OR for the primary safety outcome was 1.16 (95% CI 0.80 to 1.67) in patients < 70 years old and 2.20 (95% CI 1.47 to 3.29) in patients ≥ 70 years old (interaction P = 0.02).The rate of death or major or disabling
stroke did not differ significantly between treatments (OR 1.28, 95% CI 0.93 to 1.77, P = 0.13; I(2) = 0%). Endovascular treatment was associated with lower risks of
myocardial infarction (OR 0.44, 95% CI 0.23 to 0.87, P = 0.02; I(2) = 0%),
cranial nerve palsy (OR 0.08, 95% CI 0.05 to 0.14, P < 0.00001; I(2) = 0%) and access site haematomas (OR 0.37, 95% CI 0.18 to 0.77, P = 0.008; I(2) = 27%).The combination of death or any
stroke up to 30 days
after treatment or ipsilateral
stroke during follow-up (the primary combined safety and efficacy outcome) favoured
endarterectomy (OR 1.39, 95% CI 1.10 to 1.75, P = 0.005; I(2) = 0%), but the rate of ipsilateral
stroke after the peri-procedural period did not differ between treatments (OR 0.93, 95% CI 0.60 to 1.45, P = 0.76; I(2) = 0%).Restenosis during follow-up was more common in patients receiving endovascular treatment than in patients assigned surgery (OR 2.41, 95% CI 1.28 to 4.53, P = 0.007; I(2) = 55%). In patients with asymptomatic
carotid stenosis, treatment effects on the primary safety (OR 1.71, 95% CI 0.78 to 3.76, P = 0.18; I(2) = 0%) and combined safety and efficacy outcomes (OR 1.75, 95% CI 0.92 to 3.33, P = 0.09; I(2) = 0%) were similar to symptomatic patients, but differences between treatments were not statistically significant. Among patients not suitable for surgery, the rate of death or any
stroke between randomisation and end of follow-up did not differ significantly between endovascular treatment and medical care (OR 0.22, 95% CI 0.01 to 7.92, P = 0.41; I(2)= 79%).
AUTHORS' CONCLUSIONS: