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| |  Endarterectomy Improves Survival Over Angioplasty in Patients With Severe Symptomatic Carotid Stenosis: Presented at ESC By Chris Berrie BRUSSELS, BELGIUM -- May 24, 2006 -- Endarterectomy provides significant 30-day survival benefits over stenting for stroke and death for patients with severe symptomatic atherosclerotic carotid stenosis, according to research presented here at the 15th European Stroke Conference (ESC). Jean-Louis Mas, MD, principal investigator, professor in neurology, and head, department of neurology, University of Paris-Descartes and Stroke Unit, Saint-Anne Hospital, Paris, France, presented the multicentre, noninferiority, randomised, clinical trial on behalf of the Endarterectomy Versus Angioplasty in patients with Severe Symptomatic carotid Stenosis (EVA-3S) investigators. The primary endpoint of the study was to evaluate the risk of stroke or death within 30 days and the long-term risk of ipsilateral stroke with carotid stenting and endarterectomy in patients with severe symptomatic carotid artery stenosis, Dr. Mas detailed during his presentation on May 19th. Patients were older than 18 years and had a hemispheric or transient ischaemic attack (TIA) or a nondisabling stroke or retinal infarct within 120 days of their trial entry. Specification was also given for atherosclerotic stenosis (60%-99%), according to the North American Symptomatic Carotid Endarterectomy Trial (NASCET) scale in the symptomatic carotid artery, confirmed by catheter angiography or by both carotid duplex screening and magnetic resonance angiography. The study excluded patients with disabling stroke (modified Rankin Score [mRS] >/= 3), nonatherosclerotic carotid disease, severe tandem lesions, and previous revascularisation procedure for the symptomatic stenosis. Angiographic appearance of the stenotic lesion and the contralateral carotid artery were not factors in patient selection. To ascertain the correct standardisation across the 30 centers involved, specifications were made and followed regarding the experience of the investigators and the performance of the procedures. This included the procedures being carried out within 2 weeks of randomisation. While the endarterectomy procedure followed customary practice, Dr. Mas indicated that the stenting procedure had to follow certain specifications -- femoral route; use of approved stents and protection devices; >/= 2 stenting procedures with any new device before use in the trial; optional cerebral protection, followed later by the recommendation to use it systematically; and use of aspirin 100 to 300 mg and clopidogrel 75 mg or ticlopidine 500 mg for 3 days before and 30 days after stenting. The researchers randomised 262 patients to endarterectomy (mean age, 70.3 years; male, 78.0%) and 265 to stenting (mean age, 69.1 years; male 72.4%). The analysis included 259 and 261, respectively, as randomised. Most of the patient baseline characteristics were not significantly different between the endarterectomy and stenting groups with regards to hypertension, diabetes, hypercholesterolaemia, tobacco use, and prior coronary artery bypass graft/stenting. Similarly, analysis of the subgroups at baseline also showed no significant differences within the distributions of qualifying events, Rankin at randomization, degree of carotid stenosis, and time from event to treatment. However, a significant difference was seen for prior stroke, with more in the endarterectomy group (20.1% vs 12.6%; P =.02). For the overall primary endpoint of 30-day risk of stroke or death, this was significantly increased in the stenting group compared with endarterectomy (3.9% vs 9.6%, respectively; unadjusted relative risk [RR], 2.5; 95% confidence interval [CI], 1.2-5.1; P =.01). When broken down further, stenting showed a favourable trend towards risk of death (1.2% vs 0.8%; RR, 0.70; 95% CI, 0.1-3.9), significantly greater risk for nonfatal stroke (2.7% vs 8.8%; RR, 3.3; 95% CI, 1.4-7.5), and a worse trend for the combination of disabling stroke or death (1.5% vs 3.4%; RR, 2.2; 95% CI, 0.70-7.2). A significant benefit was seen for stenting with cerebral protection for 30-day stroke or death (n = 227; 7.9%) over stenting without cerebral protection (n = 20; 25%; P =.03). But the different centres and interventionists had no significant effects on the relative risks of stroke or death. For the secondary outcomes, stenting showed a significantly lower risk for cranial nerve injury (10.4% vs 1.5%; RR, 0.15; 95% CI, 0.05-0.40), and a beneficial trend for systemic complications (3.1% vs 1.9%; RR, 0.6; 95% CI, 0.2-1.9). Conversely, trends against stenting were apparent for both major local complications (1.2% vs 3.1%; RR, 2.6; 95% CI, 0.7-9.9) and TIA (0.8% vs 2.3%; RR, 3.0; 95% CI, 0.6-14.6). "In patients with severe symptomatic atherosclerotic carotid stenosis, endarterectomy is preferable to stenting," Dr. Mas concluded. He indicated, however, that further information should be available with the later long-term follow-up of this trial, to ascertain whether this advantage of endarterectomy is sustained. As an extension from this study, he said that to provide more definitive answers as to the overall benefit-to-risk profiles of these 2 procedures, and to allow meaningful subgroup analyses, there remains the need for greater patient numbers and full meta-analyses.
[Presentation title: Endarterectomy Versus Angioplasty in Patients With Severe Symptomatic Carotid Stenosis. Abstract 6]
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