International Carotid Stenting Study Investigators. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. The Lancet; March 2010: 985-95.
In a nutshell
The International Carotid Stenting Study is a multicentre, international, randomised controlled trial comparing carotid stenting with carotid endarterectomy in patients with symptomatic carotid stenosis. Patients and investigators were not masked to treatment allocation but independent clinicians who were not directly involved with the trial assessed patients. The primary outcome measure of the trial was the three-year rate of fatal or disabling stroke in any territory.
This paper reports on the interim safety analysis. The main outcome measure for this was the 120-day rate of stroke, death or procedural myocardial infarction (MI). A total of 1713 patients were randomised into the two groups. Between randomisation and 120 days, the incidence of stroke, death or MI was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs 44 events; HR 1.69; 1.16-2.45; p=0.006). There was no significant difference between the groups in death and disabling stroke (34 [4%] in the stenting group compared to 27 [3.2%] in the endarterectomy group). However, the risk of any stroke (7.7 vs 4.1%; p=0.002) and all cause death (2.3 vs 0.8%; p=0.017) were higher in the endarterectomy group. Cranial nerve palsies and haematomas were significantly higher in the endarterectomy group.
Second opinion
This study reports the interim safety analysis of this trial. The full results of the trial will only be available in 2012. The main difference between the two groups appears to be in the number of non-disabling strokes being higher in the stenting group while nerve palsies and haematomas are more common in the endarterectomy group. The findings of this interim analysis, however, are consistent with the findings of the SPACE and EVA-3S trials which failed to show non-inferiority for carotid stenting compared with endareterectomy. The recommendations of the authors of the ICSS report are that carotid endarterectomy should remain the treatment of choice for patients who are suitable for surgery. The results of other trials such as CREST and the full results of the ICSS should provide further data in this field.
The verdict
- Carotid stenting is associated with higher risks of stroke than carotid endarterctomy in patients with symptomatic carotid stenosis.
- Carotid endarterectomy remains the treatment of choice in those suitable for surgery.
Kevin Cassar
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