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Asymptomatic Carotid Surgery Trial-2 (ACST-2): an international randomised trial to compare carotid endarterectomy with carotid artery stenting to prevent stroke

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Around 5,000 patients with narrowed carotid arteries will be randomly assigned to either surgical removal of the blockage or a less invasive stent procedure, in a head-to-head trial to determine which better prevents stroke. Why this matters: About one million adults in Europe have atherosclerotic narrowing of one or both carotid arteries, putting them at substantially increased risk of stroke over the next 5 to 10 years, even with long-term medication. Previous trials showed that carotid endarterectomy (CEA) – surgical removal of the plaque – greatly reduces stroke risk, but carries a 3% risk of peri-operative stroke or death. Carotid artery stenting (CAS) is an increasingly popular alternative that may have lower immediate risks, but no large trial has reliably compared the two. Potential impact: If ACST-2 shows that CAS has lower peri-operative risks while matching CEA’s long-term benefits, it could shift clinical practice toward the less invasive procedure, reducing hospital stays and recovery times for thousands of patients. If CEA proves superior, it would reaffirm surgery as the standard. Either way, the findings will directly affect treatment decisions for the many patients with carotid stenosis who face a daily risk of disabling or fatal stroke. The trial also includes health economic evaluation to assess quality-of-life and cost-effectiveness.

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About one million adults in Europe alone have atherosclerotic narrowing of one or both of their carotid arteries. They are therefore at a substantially increased risk of stroke over the next 5 or 10 years, even with long-term medical treatment that reduces this risk (e.g. antiplatelet, antihypertensive and lipid-lowering drugs). Our previous international randomised trial in 3000 such patients (ACST) showed that CEA (with 3% risk of peri-operative stroke or death) greatly reduces the subsequent stroke risk. CAS is an increasingly popular alternative to CEA that may produce lower peri-operative risks with long-term benefits comparable to CEA. Our proposed new international trial (ACST-2) will randomise more than 5000 such patients equally between CEA and CAS. The primary aim of this trial is to compare the immediate operative risks (up to 1 month post-procedure) and the long-term (5-year) risks between the two treatment interventions. Secondary to this, comparisons of health-related quality of life will be assessed as part of the health economic evaluation. ACST-2 is the only proposed trial that could be large enough to address this important question reliably. The findings which emerge from ACST-2 will affect thousands of patients with carotid artery stenosis who are at risk of stroke.

Related Research

Grants with similar aims, by meaning.

Asymptomatic carotid surgery trial-2 (ACST-2): an international randomised trial to compare carotid endarterectomy with carotid artery stenting to prevent stroke.
10-year median follow-up of long-term stroke onset rates in ACST-2, the largest randomised trial of carotid surgery vs carotid stenting
The 2nd European Carotid Surgery Trial (ECST2)
The Second European Carotid Surgery Trial (ECST-2): Pilot study
Asymptomatic Carotid Surgery Trial-2. ACST2.

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