In the Intermediate Term, Carotid Stenting and Surgery Seem Equally Safe and Effective
Last Updated: 2010-02-25 18:30:21 -0400 (Reuters Health)
NEW YORK (Reuters Health) - For carotid artery stenosis, endarterectomy is slightly superior to stenting in the short-term but in the intermediate-term there's no longer any difference between the two in safety or efficacy, a meta-analysis has found.
"The new finding here is that, in the long-term, these two procedures are equivalent," study author Dr. Hitinder Gurm told Reuters Health in a phone interview. "Over time, the gap has narrowed between the efficacy and safety of endarterectomy and stenting for treating carotid artery stenosis."
For the meta-analysis reported February 17th in BMJ Online First, Dr. Gurm, from the University of Michigan in Ann Arbor, and colleagues pooled the data from 11 randomized trials that compared the two procedures in 4796 patients. Ten reports provided periprocedural data (less than 30 days); nine included outcomes at 1 to 4 years. The studies had been done between 1990 and 2009; the researchers identified them using BIOSIS, Embase, Medline, the Cochrane central register of controlled trials, International Pharmaceutical Abstracts database, ISI Web of Science, and Google scholar and bibliographies.
For the primary endpoint, the weighted average of periprocedural death or stroke was significantly lower for carotid endarterectomy than for carotid artery stenting (5.4% vs 7.3%, OR 0.67, p = 0.025).
For secondary endpoints, the periprocedural risk of mild stroke was significantly lower for carotid endarterectomy than for carotid artery stenting (4.2% vs 5.7%, OR 0.65, p = 0.049). On the other hand, endarterectomy increased the risks of myocardial infarction (MI) (2.6% vs 0.9%, OR 2.69, p = 0.036) and cranial nerve injury (5.7% vs 0.45%, OR 10.2, p < 0.001).
But with regard to periprocedural outcomes, the authors say they saw "an important change in the comparative efficacy of the two procedures over time."
They add, "The distinct inferiority of carotid artery stenting compared with carotid endarterectomy shown early on by cumulative meta-analysis diminished over time when newer trials were added sequentially."
For the intermediate term, the two treatment groups did not differ significantly for stroke or death, Dr. Gurm and colleagues said.
Meanwhile, two separate teams of researchers reporting interim data from a 3-year trial of carotid stenting versus endarterectomy are still maintaining that surgery is the procedure of choice, for now at least.
The first of their papers, published online in The Lancet on February 26 by Dr. Martin M. Brown, from University College London, U.K., and colleagues, presents the 120-day rates of stroke, death, or procedural 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.
At 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, p = ns). 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.
As in the meta-analysis, cranial nerve palsy was less common with stenting than with surgery: 1 vs. 45. Likewise, fewer stenting patients had hematomas: 31 vs. 50 events.
The second paper -- also appearing online February 26th, but in The Lancet Neurology -- reports on an ICSS substudy that focused on magnetic resonance imaging results. MRI 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 says, 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.
So who to believe? The meta-analysis -- which in fact included the ICSS interim data -- or the researchers writing in The Lancet that endarterectomy is still best for now?
The authors of the meta-analysis answer this question themselves. Even given their findings, they write, "Patients with symptoms requiring carotid revascularization should currently be offered carotid endarterectomy as first choice, with carotid artery stenting reserved for patients at high surgical risk. Trials of contemporary carotid artery stenting versus carotid endarterectomy are needed to better understand the role for each treatment in patients with or without symptoms."
BMJ 2010.
Lancet 2010.
Lancet Neurology 2010.
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