Among patients with symptomatic carotid stenosis, stenting was comparable to endarterectomy in terms of long-term functional outcome and risk for fatal bleeding or disabling stroke, according to results of the randomized ICSS trial.
In the study, researchers from 50 international centers randomly assigned patients (n=1,713) with symptomatic carotid stenosis in a 1:1 fashion to stenting (n=855) or endarterectomy (n=858). The researchers performed a per-protocol analysis from 31 days after treatment and an intent-to-treat (ITT) analysis, which included 1,710 patients after three withdrew.
Fatal or disabling stroke in any territory after randomization served as the primary endpoint. Median follow-up was 4.2 years.
According to data, the number of fatal or disabling strokes were almost identical (stenting, n=52; endarterectomy, n=49). Similarly, the 5-year risk for fatal or disabling strokes did not significantly differ between groups (stenting, 6.4% vs. endarterectomy, 6.5%; HR=1.06; P=.77).
However, the 5-year rate of any stroke was higher in the stenting group (ITT analysis, 15.2% vs. 9.4%; P<.001; per-protocol analysis, 8.9% vs. 5.8%; P=.04); these were mainly nondisabling strokes, according to researchers. “This feature, however, must be weighed against the increased risk of procedural myocardial infarction, cranial nerve palsy and access-site hematoma associated with endarterectomy,” they wrote.
There also was no significant difference between arms in distribution of modified Rankin scale scores at 1 year, 5 years and final follow-up.
“Now that we know stenting is effective in the long term, more staff should be trained to carry out the procedure and gain experience,” Martin M. Brown, MD, study researcher from the UCL Institute of Neurology, London, said in a press release. “Otherwise, there is a vicious cycle where nobody at a center has stenting experience, so patients are only offered endarterectomy and staff cannot learn or observe the procedure.”
Disclosure: Brown reports no relevant financial disclosures. The other researchers report financial disclosures with Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, Sanofi Aventis, Servier and Shire.