Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2

CEA vs CAS Comparison:

Early RCTs conducted in the 2000s showed that CAS was associated with a higher risk of procedural stroke or death compared to CEA (8.9% vs 5.8%; RR 1.53, 95% CI 1.20-1.96, p=0.0006). However, CAS was found to be as effective as CEA in preventing recurrent ipsilateral strokes up to 10 years after treatment. Interestingly, an ancillary study of the ICSS trial showed that significantly more patients in the CAS group (50%) than in the CEA group (17%) had new ischemic lesions on diffusion-weighted MRI (DWI), suggesting that DWI might serve as a surrogate outcome measure for future carotid intervention trials.

Data Analysis and Recent Advances:

Individual pooled data analysis of RCTs indicated that CAS could be as safe and effective as CEA in patients under 70 years old. Recent advances in CAS technology, stenting techniques, antiplatelet therapy, and pre-treatment imaging have improved the periprocedural safety of CAS. Due to its ability to treat patients soon after a stroke, CAS has become increasingly used in routine clinical practice.

Study Objectives:

The question remains whether CAS is as safe as CEA in patients with recent symptomatic severe carotid stenosis. The study's objectives are:

Primary Objective:

To assess whether carotid stenting is non-inferior to carotid endarterectomy in preventing new ischemic lesions on DWI MRI, confirmed by a core lab.

* To assess the difference between groups regarding post-intervention MRI characteristics in terms of ischemic lesion number and size, vessel occlusion and hemorrhagic transformation * To assess differences between groups with regard to the procedural risks and efficacy (within 30 days after procedure) of

1. any stroke or death 2. any stroke, 3. disabling or fatal stroke 4. death 5. transient ischemic attack 6. myocardial infarction 7. local complication 8. cranial nerve palsy

• Profile of lesions [Срок оценки: From 3 days before procedure to 7 days after procedure]
• Vessel Occlusion Profile [Срок оценки: From 3 days before procedure to 7 days after procedure]
• Hemorrhage [Срок оценки: From 3 days before procedure to 7 days after procedure]
• Stroke/Mortality [Срок оценки: From randomization to 30 days after procedure]
• Stroke Incidence Rate [Срок оценки: From randomization to 30 days after procedure]
• Severe Stroke Incidence [Срок оценки: From randomization to 30 days after procedure]
• Mortality [Срок оценки: From randomization to 30 days after procedure]
• TIA Incidence [Срок оценки: From randomization to 30 days after procedure]
• MI Occurrence [Срок оценки: From randomization to 30 days after procedure]
• Local complication [Срок оценки: From randomization to 30 days after procedure]
• Cranial Nerve Injury Events [Срок оценки: From randomization to 30 days after procedure]
• Hospitalization Duration [Срок оценки: From the date of the carotid artery stenting (CAS) or endarterectomy (CEA) procedure until the date of hospital discharge, assessed up to 30 days]