Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: carotid endarterectomy, Carotid artery stenting.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure carotid 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. - Procedure Carotid 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.
Primary outcome measures
- DWI Lesion Detection Rate [Time frame: From 3 days before procedure to 7 days after procedure]
Secondary outcome measures (12)
- Profile of lesions [Time frame: From 3 days before procedure to 7 days after procedure]
- Vessel Occlusion Profile [Time frame: From 3 days before procedure to 7 days after procedure]
- Hemorrhage [Time frame: From 3 days before procedure to 7 days after procedure]
- Stroke/Mortality [Time frame: From randomization to 30 days after procedure]
- Stroke Incidence Rate [Time frame: From randomization to 30 days after procedure]
- Severe Stroke Incidence [Time frame: From randomization to 30 days after procedure]
- Mortality [Time frame: From randomization to 30 days after procedure]
- TIA Incidence [Time frame: From randomization to 30 days after procedure]
- MI Occurrence [Time frame: From randomization to 30 days after procedure]
- Local complication [Time frame: From randomization to 30 days after procedure]
- Cranial Nerve Injury Events [Time frame: From randomization to 30 days after procedure]
- Hospitalization Duration [Time frame: From the date of the carotid artery stenting (CAS) or endarterectomy (CEA) procedure until the date of hospital discharge, assessed up to 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- Centre hospitalier Sainte-Anne — Paris
Identifiers
NCT: NCT07054060 · D24-P001 · PHRC-22-0121 · 2024-A01377-40