Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.
Background
Significant asymptomatic carotid stenosis (
ACS
) is associated with higher risk of strokes. While the prevalence of moderate and severe
ACS
is low in the general population, prediction models may allow identification of individuals at increased risk, thereby enabling targeted screening. We identified established prediction models for
ACS
and externally validated them in a large screening population.
Methods and Results
Prediction models for prevalent cases with ≥50% ACS were identified in a systematic review (975 studies reviewed and 6 prediction models identified [3 for moderate and 3 for severe
ACS
]) and then validated using data from 596 469 individuals who attended commercial vascular screening clinics in the United States and United Kingdom. We assessed discrimination and calibration. In the validation cohort, 11 178 (1.87%) participants had ≥50% ACS and 2033 (0.34%) had ≥70%
ACS
. The best model included age, sex, smoking, hypertension, hypercholesterolemia, diabetes mellitus, vascular and cerebrovascular disease, measured blood pressure, and blood lipids. The area under the receiver operating characteristic curve for this model was 0.75 (95%
CI,
0.74–0.75) for ≥50%
ACS
and 0.78 (95%
CI,
0.77–0.79) for ≥70%
ACS
. The prevalence of ≥50%
ACS
in the highest decile of risk was 6.51%, and 1.42% for ≥70%
ACS
. Targeted screening of the 10% highest risk identified 35% of cases with ≥50%
ACS
and 42% of cases with ≥70%
ACS
.
Conclusions
Individuals at high risk of significant
ACS
can be selected reliably using a prediction model. The best‐performing prediction models identified over one third of all cases by targeted screening of individuals in the highest decile of risk only.
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