European Carotid Surgery Trial 2 (ECST-2): a randomised controlled trial
Stroke
Immediate endartorectomy and optimised medical therapy. All patients will have their medication adjusted to reach recommended levels for cholesterol and blood pressure, and receive advice about healthy lifestyle. Half the patients will be randomly allocated to have surgery or stenting as soon as possible, the other half will continue on medical treatment alone until such time, if ever, that revascularisation becomes clearly indicated. Patients will be seen regularly for several years to check their cholesterol and blood pressure remain on target and to record surgical complications and the occurrence of strokes or heart attacks. An interim safety analysis will be performed using MRI follow up to assess rates of new cerebral infarction and haemorrhage.
1. Patients over 18 years of age with atherosclerotic carotid stenosis equivalent to at least 50% measured using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method 2. Patient is medically and neurologically stable and suitable for CEA or carotid artery stenting (CAS) 3. Patients with a carotid artery risk (CAR) score indicating a 5-year ipsilateral stroke risk of <20%. This may include patients with asymptomatic stenosis or symptomatic stenosis associated with features (e.g. delayed presentation) indicating intermediate or lower risk, confirmed by CAR Score <20% 4. Clinicians are uncertain about which treatment modality is best for the individual patient 5. Patient or appropriate representative is able and willing to give informed consent 6. Male and female participants
1. Patients (or their representatives) unwilling to have either treatment modality 2. Patients unwilling or unable to participate in follow up for whatever reason 3. Patients with a Rankin score greater than 3 for any reason. Such patients may be eligible for inclusion at such time as they improve to a Rankin score of 3 or less 4. Patients who are medically or neurologically unstable or have progressing neurological signs. Such patients may be eligible for inclusion at such time as they become stable 5. Patients in whom it is planned to carry out coronary artery bypass grafting or other major surgery within one month of carotid stenting or endarterectomy 6. Patients with a CAR Score >20% or other reason for believing the patient would get clear benefit from CEA or CAS 7. Patients not suitable for either surgery or stenting due to anatomical factors 8. Carotid stenosis caused by nonatherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy 9. Previous CEA or stenting in the randomised artery 10. Patients who are known to be pregnant 11. Patients who have a life expectancy of less than two years due to a preexisting condition e.g. cancer 12. Patients intolerant or allergic to all of the medications available for optimised modern medical therapy 13. Patients in clinical trials of medicinal products (CTIMPS) or who have been in a CTIMP within the last 4 months will not be enrolled 14. Patients in other trials (both stroke related and non stroke related) may be enrolled where this would not conflict with the treatments used in ECST2 or place undue additional burdens on the patient