EVA3S: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by: Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

The purpose of this study is to evaluate whether carotid angioplasty with stent (CAS) is as safe and effective as carotid surgery in regards to:

1. the risk of stroke and death within 30 days of the procedure;
2. the long-term risk of ipsilateral carotid territory stroke, in patients with recently symptomatic, severe carotid stenosis suitable for both CAS and carotid endarterectomy.

Condition or disease	Intervention/treatment	Phase
Transient Ischemic Attack; Carotid Stenosis; Atherosclerosis	Device: Carotid angioplasty and stenting with cerebral protection	Phase 3

Detailed Description:

Findings from two large randomized clinical trials - NASCET and ECST - have established endarterectomy as the standard treatment for severe symptomatic carotid artery stenosis. Compared to endarterectomy, stenting with or without cerebral protection has the advantage of avoiding general anesthesia and incision in the neck that could lead to nerve injury and wound complications. The costs may be less than those of surgery, mainly because of a shorter hospital stay. However, stenting also carries a risk of stroke and local complications. Unlike endarterectomy, which has known long-term benefits, stenting does not remove the atheromatous plaque, and the long-term efficacy of this technique needs also to be assessed. Several trials are in progress in Europe and the United States.

We established this trial to evaluate whether stenting is not inferior to endarterectomy concerning (a) the risk of stroke or death within 30 days of procedure and (b) the long-term risk of ipsilateral stroke, in patients with recently symptomatic, severe carotid stenosis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 900 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis
• Study Start Date: November 2000
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Carotid angioplasty and stenting with cerebral protection	Device: Carotid angioplasty and stenting with cerebral protection; Carotid angioplasty and stenting with cerebral protection

Outcome Measures

Primary Outcome Measures :

1. Any stroke or death within 30 days of the procedure [ Time Frame: during de study ]
   Any stroke or death within 30 days of the procedure

Secondary Outcome Measures :

1. Clinical: Myocardial infarction within 30 days of the procedure [ Time Frame: during the study ]
   Clinical: Myocardial infarction within 30 days of the procedure
2. Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA]) [ Time Frame: during the study ]
   Other complications within 30 days of the procedure: cerebral (transient ischemic attack [TIA])
3. locoregional (e.g. cranial nerve palsy, complications at the site of puncture) [ Time Frame: during the study ]
   locoregional (e.g. cranial nerve palsy, complications at the site of puncture)
4. General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period [ Time Frame: during the study ]
   General: Any disabling stroke or death within 30 days of the procedure plus disabling or fatal ipsilateral stroke during the follow-up period
5. Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period [ Time Frame: during the study ]
   Any stroke or death within 30 days of the procedure plus any stroke (or any stroke or death) during the follow-up period
6. TIA during the follow-up period [ Time Frame: during the study ]
   TIA during the follow-up period
7. Functional status at the end of the study [ Time Frame: during the study ]
   Functional status at the end of the study
8. Anatomical: Carotid restenosis (> 70% on carotid ultrasound) [ Time Frame: during the study ]
   Anatomical: Carotid restenosis (> 70% on carotid ultrasound)
9. Integrity of the stent 2 years after the procedure (on cervical radiogram) [ Time Frame: during the study ]
   Integrity of the stent 2 years after the procedure (on cervical radiogram)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• In brief, patients are eligible if they have experienced a carotid TIA or non disabling stroke within 4 months before randomisation and if they have an atherosclerotic stenosis of the region of the ipsilateral carotid bifurcation of 60% or more, as determined by the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method, that investigators believe is suitable for both carotid endarterectomy and endovascular treatment. The degree of stenosis warranting treatment initially set at 70% or more was subsequently set at 60% or greater to reflect current generally accepted practice in the treatment of symptomatic carotid stenosis. The presence of a 60% or more ipsilateral carotid stenosis has to be confirmed by conventional digital subtraction angiography or the combination of carotid Duplex scanning and magnetic resonance angiography, provided the results of these non-invasive techniques are concordant.

Exclusion Criteria:

• Patients cannot be included if they have a disabling stroke (mRS >=3), a non atherosclerotic carotid disease, a severe intracranial carotid artery stenosis, contra-indications to heparin, ticlopidine or clopidogrel.
• There is no age limit.
• The presence of contralateral occlusion and/or the angiographic appearance of the stenotic lesion are not factors in treatment selection. The randomisation algorithm takes centre and degree of stenosis (more or less than 90% stenosis) into account. Patients must be treated as soon as possible after random assignment, in any case within 2 weeks of randomisation.

Contacts and Locations

Locations

France

Sainte-Anne Hospital: Department of Neurology

Paris, Ile de France, France, 75674 cedex14

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Jean-Louis MAS, Pr, MD, PhD; Assistance Publique - Hôpitaux de Paris

More Information

Publications of Results:

Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, Larrue V, Lièvre M, Leys D, Bonneville JF, Watelet J, Pruvo JP, Albucher JF, Viguier A, Piquet P, Garnier P, Viader F, Touzé E, Giroud M, Hosseini H, Pillet JC, Favrole P, Neau JP, Ducrocq X; EVA-3S Investigators. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med. 2006 Oct 19;355(16):1660-71.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Müller MD, von Felten S, Algra A, Becquemin JP, Brown M, Bulbulia R, Calvet D, Eckstein HH, Fraedrich G, Halliday A, Hendrikse J, Gregson J, Howard G, Jansen O, Mas JL, Brott TG, Ringleb PA, Bonati LH; Carotid Stenosis Trialists’ Collaboration. Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis. Stroke. 2018 Nov;49(11):2715-2722. doi: 10.1161/STROKEAHA.118.020684.

Rantner B, Kollerits B, Roubin GS, Ringleb PA, Jansen O, Howard G, Hendrikse J, Halliday A, Gregson J, Eckstein HH, Calvet D, Bulbulia R, Bonati LH, Becquemin JP, Algra A, Brown MM, Mas JL, Brott TG, Fraedrich G; Carotid Stenosis Trialists’ Collaboration. Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery: Results From 4 Randomized Controlled Trials. Stroke. 2017 Jun;48(6):1580-1587. doi: 10.1161/STROKEAHA.116.016233. Epub 2017 Apr 28.

Mas JL, Arquizan C, Calvet D, Viguier A, Albucher JF, Piquet P, Garnier P, Viader F, Giroud M, Hosseini H, Hinzelin G, Favrole P, Hénon H, Neau JP, Ducrocq X, Padovani R, Milandre L, Rouanet F, Wolff V, Saudeau D, Mahagne MH, Sablot D, Amarenco P, Larrue V, Beyssen B, Leys D, Moulin T, Lièvre M, Chatellier G; EVA-3S Investigators. Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial. Stroke. 2014 Sep;45(9):2750-6. doi: 10.1161/STROKEAHA.114.005671. Epub 2014 Jul 31.

Rantner B, Goebel G, Bonati LH, Ringleb PA, Mas JL, Fraedrich G; Carotid Stenting Trialists' Collaboration. The risk of carotid artery stenting compared with carotid endarterectomy is greatest in patients treated within 7 days of symptoms. J Vasc Surg. 2013 Mar;57(3):619-626.e2; discussion 625-6. doi: 10.1016/j.jvs.2012.08.107. Epub 2012 Dec 11.

Mas JL, Trinquart L, Leys D, Albucher JF, Rousseau H, Viguier A, Bossavy JP, Denis B, Piquet P, Garnier P, Viader F, Touzé E, Julia P, Giroud M, Krause D, Hosseini H, Becquemin JP, Hinzelin G, Houdart E, Hénon H, Neau JP, Bracard S, Onnient Y, Padovani R, Chatellier G; EVA-3S investigators. Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol. 2008 Oct;7(10):885-92. doi: 10.1016/S1474-4422(08)70195-9. Epub 2008 Sep 5.

• Responsible Party: Cecile jourdain, Department Clinical Research of developpement
• ClinicalTrials.gov Identifier: NCT00190398 History of Changes
• Other Study ID Numbers: P990402
• First Posted: September 19, 2005
• Last Update Posted: May 2, 2011
• Last Verified: February 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Prospective; Randomised; Open; Blinded End-point; PROBE Study; Ischemic stroke

Additional relevant MeSH terms:

Constriction, Pathologic; Atherosclerosis; Ischemic Attack, Transient; Carotid Stenosis; Pathological Conditions, Anatomical; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases