Source: DGNews  |  Posted 2 years ago

By Judith Moser, MD

STOCKHOLM, Sweden -- May 28, 2009 -- In patients with symptomatic carotid stenosis, endarterectomy of the carotid artery is safer than stenting, researchers stated here at the 18th European Stroke Conference (ESC).

Principal investigator Martin M. Brown, MD, Institute of Neurology, University College London, London, United Kingdom, presented the safety results of the randomised International Carotid Stenting Study (ICSS) trial study on behalf of the ICSS investigators here on May 27.

ICSS is a multicentre, open, randomised trial aimed at determining the risks and long-term benefits of carotid artery stenting (CAS) in comparison to carotid endarterectomy (CEA) in patients aged over 40 years with extracranial carotid artery stenosis and recent, relevant symptoms.

Of 1,710 patients, 853 were allocated to CAS and 857 to CEA.

The primary long-term outcome measure (long-term survival free of disabling stroke) awaits the completion of the follow-up in 2011.

Dr. Brown presented the results for the primary safety measure, which was the 30-day rate of stroke, myocardial infarction (MI), or death.

The results of the intent-to-treat analysis were highly statistically significant in favour of the endarterectomy. Stroke, death, or periprocedural MI occurred in 8.5% and 5.1% of patients with CAS and CEA, respectively (P = .004).

Furthermore, any stroke events (secondary outcome) were twice as frequent in the stenting group (65 vs 34 events). “This difference was largely driven by nondisabling strokes,” Dr. Brown said.

In terms of disabling stroke, numbers were almost identical between the 2 arms (CAS = 17; CEA = 19). There was a small excess of fatal stroke in the CAS group (9 vs 2).

Almost all strokes were ipsilateral on the side of treatment, and predominantly ischaemic.

As expected, there was a large excess in cranial nerve palsy in the CEA patients (44 vs 1 events). However, as Dr. Brown noted, only 2 patients (1 in each arm) were disabled at 30 days.

Also, haematoma was more common in the patients randomised to surgery (50 vs 31 events).

Of event clusters observed (secondary outcome) 3 of 4 significantly favoured endarterectomy. For the cluster stroke or death, numbers was nearly double in the CAS group (8.5% vs 4.6%; P = .001). Only for disabling or fatal stroke or death, event rates did not differ significantly (4.0% vs 3.1%; P = .28).

The per-protocol 30-day analyses excluded crossovers and patients who had never received treatment. “In fact, the results are almost identical to those of the intention-to-treat analysis,” Dr. Brown emphasised.

In this analysis, stroke and death were also found twice as often in the stenting arm than in the surgery arm with a highly significant difference of 4% (7.4% vs 3.4%; P = .001). Any strokes were seen twice as frequently in the CAS group (7.0% vs 3.3%; P = .001).

“Carotid endarterectomy is the treatment of choice for suitable patients with recently symptomatic carotid stenosis,” Dr. Brown concluded.

[Presentation title: Safety Results of the International Carotid Stenting Study (ICSS): Early Outcome of Patients Randomised Between Carotid Stenting and Endarterectomy for Symptomatic Carotid Stenosis]