Stroke
Conditions
Keywords
CEA, CAS, stroke, Magnetic resonance imaging, Carotid Artery Stenting, Carotid Endarterectomy
Brief summary
Carotid stenosis caused by atherosclerosis is a significant risk factor for ischemic stroke, accounting for up to 15% of all strokes and transient ischemic attacks. Randomized clinical trials (RCTs) have demonstrated the benefits of carotid endarterectomy (CEA) in reducing stroke risk in patients with severe symptomatic carotid stenosis. Carotid artery stenting (CAS) has been developed as an alternative to CEA, offering several potential advantages, such as avoiding local surgical complications. However, unlike CEA, CAS has not been compared to medical therapy in RCTs for symptomatic carotid stenosis.
Detailed description
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
Interventions
PROCEDUREcarotid endarterectomy
Carotid endarterectomy is a surgical procedure used to reduce the risk of stroke due to carotid artery stenosis. During an endarterectomy, the surgeon opens the artery and removes the plaque.
PROCEDURECarotid artery stenting
Carotid artery stenting is an endovascular procedure in which a stent is deployed in the lumen of the carotid artery to treat narrowing of the carotid artery and reduce the risk of stroke.
Sponsors
Direction Générale de l'Offre de Soins
Centre Hospitalier St Anne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age 18 years or over * Hemispheric or retinal transient ischemic attack or a non-disabling stroke (or retinal infarct) within 15 days before enrolment * Stenosis of 50% to 99% in the symptomatic carotid artery (NASCET method) for whom revascularisation is decided according to guidelines
Exclusion criteria
* Patients unwilling or unable to participate in follow-up for whatever reason * Preexisting disability (Modified Rankin Score ≥ 3) * Nonatherosclerotic carotid disease * Severe tandem lesions * Previous revascularization of the symptomatic carotid stenosis * History of bleeding disorder * Unstable angina * Contraindication to dual antiplatelet therapy * Contraindication to MRI * Life expectancy of less than 2 years * Percutaneaous or surgical intervention within 30 days before or after the study procedure * Stenotic lesion on arterial workup appeared as not a factor in the selection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DWI Lesion Detection Rate | From 3 days before procedure to 7 days after procedure | Imaging endpoint : Proportion of patients having at least one new lesion on post-treatment Diffusion-Weigthed Imaging (DWI) MRI compared to pre-treatment DWI MRI and confirmed by a core lab. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel Occlusion Profile | From 3 days before procedure to 7 days after procedure | Imaging endpoint : Proportion of patients having a new intracranial vessel occlusion on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure. |
| Hemorrhage | From 3 days before procedure to 7 days after procedure | Imaging endpoint : Hemorrhagic transformation on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure. |
| Stroke/Mortality | From randomization to 30 days after procedure | Clinical endpoint : proportion of patients having any stroke or death during periprocedural period. |
| Stroke Incidence Rate | From randomization to 30 days after procedure | Clinical endpoint : Proportion of patients having any stroke during periprocedural period. |
| Severe Stroke Incidence | From randomization to 30 days after procedure | Clinical endpoint : Proportion of patients having any disabling or fatal stroke during periprocedural period. |
| Mortality | From randomization to 30 days after procedure | Clinical endpoint : Proportion of patients who died during periprocedural period. |
| Profile of lesions | From 3 days before procedure to 7 days after procedure | Imaging endpoint : Number and size of new lesions on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure. |
| MI Occurrence | From randomization to 30 days after procedure | Clinical endpoint : Proportion of patients having myocardial infarction during periprocedural period. |
| Local complication | From randomization to 30 days after procedure | Clinical endpoint : cervical or groin or radial hematoma, infection, arteriovenous fistula at puncture site, lower-limb arterial occlusion during periprocedural period. |
| Cranial Nerve Injury Events | From randomization to 30 days after procedure | Clinical endpoint : Proportion of patients having cranial nerve injury during periprocedural period. |
| Hospitalization Duration | From the date of the carotid artery stenting (CAS) or endarterectomy (CEA) procedure until the date of hospital discharge, assessed up to 30 days | Healthcare endpoint : number of days the patient stayed in the hospital stay |
| Procedure Delay | From the date of patient randomization until the date of carotid artery stenting (CAS) or endarterectomy (CEA) procedure, assessed up to 15 days | Operational endpoint: number of days between the date at which the patient is randomized and the date at which the carotid artery stenting (CAS) or endarterectomy) is proceeded |
| Ischemic Events | From 3 days before procedure to 7 days after procedure. | Clinical endpoint: Incidence of ischemic events among patients with confirmed new lesions on post-procedure DWI MRI (as verified by core lab assessment). The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure. |
| TIA Incidence | From randomization to 30 days after procedure | Clinical endpoint : Proportion of patients having a Transient ischemic attack during periprocedural period. |
Countries
France
Contacts
Primary ContactDavid Calvet, Professor
Backup ContactDRCI DRCI
Outcome results
None listed