Original title: Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial. Reference: Bonati LH et al. Lancet. 2014;Epub ahead of print.
Carotid stenting is an alternative to endarterectomy though long term efficacy remains unknown. This study reports the long term follow up of the International Carotid Stenting Study.
Patients with carotid artery symptomatic lesions were randomized 1:1 to endarterectomy vs. carotid stenting in 50 centers around the world. The events were assessed by an independent committee blind to assigned treatment. Primary end point was disabling or fatal stroke in any territory from randomization to end of follow up. Functional ability was measured with the modified Rankin scale. 1,713 patients were randomized to PCI (n=855) vs endarterectomy (n=858) and followed by a median of 4.2 years.
The total number of disabling or fatal strokes was 52 for the PCI group and 49 for the surgery group, resulting in a similar accumulative risk at 5 years for both strategies (6.4% vs 6.5%; HR 1.06, IC 95% 0.7 to 1.57; p=0.77).
Considering any stroke, more events were observed with stenting (119 events vs 72) with an accumulated risk at 5 years of 15.2% vs 9.4% (HR 1.71, IC 95% 1.28 to 2.30; p<0.001) but events were mostly non disabling. Score distribution in the modified Rankin scale at one year, 5 years or end of follow up were no different in the two groups.
Conclusion
Long term functional result as well as disabling or fatal stroke risk was similar for carotid stenting and endarterectomy in patients with symptomatic carotid artery lesions.
Editorial Comment
Increased minor stroke risk associated to carotid stenting should be counterbalanced with peri procedural infarction, brain damage and endarterectomy hematoma risks.
This study has been criticized since the start; two of the most important objections are that only 70% of PCI procedures were performed with brain protection systems, and that most operators had little experience (only 10 previous carotid stenting procedures, or a tutor, was required).
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