NEW YORK (Reuters Health) – Interim data from a 3-year trial of stenting versus endarterectomy for symptomatic carotid stenosis suggests that for now at least, surgery should remain the procedure of choice.
The report, which appears in the February 26th online issue of The Lancet, presents the 120-day rates of stroke, death, or procedural myocardial infarction (MI) from the ongoing International Carotid Stenting Study (ICSS).
Overall, the ICSS includes 1713 patients randomized to undergo stenting or endarterectomy for symptomatic carotid stenosis.
Dr. Martin M. Brown, from University College London, and colleagues report that by 120 days, the rate of disabling stroke or death in the stenting group was 4.0% compared with 3.2% in the surgery group (HR, 1.28). The corresponding stroke, death, or procedural MI rates were 8.5% and 5.2% (HR, 1.69, p = 0.006).
Compared with surgery patients, patients with stents were nearly twice as likely to have a stroke during follow-up and almost three times as likely to die from any cause.
More procedural myocardial infarctions occurred in the surgery group than in the stenting group (4 vs. 3) – but all of these events in the stenting group were fatal, whereas none of the surgery patients died from procedure-related MI.
Cranial nerve palsy was less common with stenting than with surgery: 1 vs. 45. Likewise, fewer stenting patients had hematomas: 31 vs. 50 events.
In addition, an ICSS substudy that focused on magnetic resonance imaging results — also appearing online February 26th, but in The Lancet Neurology – found fewer new ischemic brain lesions in the endarterectomy group versus the stenting group.
The substudy featured 124 stenting patients and 107 surgery patients who underwent diffusion-weighted MRI within the week before treatment and 1-3 and 27-33 days afterward.
Lead author Dr. Leo H Bonati from Hospital Basel, Switzerland and colleagues report that in the first few days after treatment, the percentage of patients with new ischemic brain lesions was much higher in the stenting group: 50% vs. 17% (p < 0.0001). The difference was even more pronounced when the analysis was limited to centers that typically use cerebral protection devices: 73% vs. 17%.
At 1 month, 33% of stenting patients had evidence of persistent brain injury, versus 8% of surgery patients (p = 0.0003).
In an editorial in The Lancer Neurology, Dr. Klaus Groschel, from Georg-August-Universitat Gottingen, Germany, comments that the present findings suggest that “the widespread use of carotid stenting, especially its routine use as first-choice treatment for symptomatic carotid stenosis, does not seem to be justified for the time being.”
Currently, he notes, the bulk of data supports endarterectomy over stenting. However, he emphasizes that this does not necessarily mean the two approaches can’t co-exist, as certain patients may be better served by stenting.
Lancet Neurology 2010.