Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2 (EVA3S-2)

Centre Hospitalier St Anne

Status: Enrolling

Conditions: Stroke

Treatments: Procedure: Carotid artery stenting; Procedure: carotid endarterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07054060

D24-P001

2024-A01377-40 (Other Identifier)

PHRC-22-0121 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 2 patient groups

surgical arm

Active Comparator group

Description:

carotid endarterectomy

Treatment:

Procedure: carotid endarterectomy

Stenting arm

Active Comparator group

Description:

Carotid artery stenting

Treatment:

Procedure: Carotid artery stenting