The International Carotid Stenting Study (ICSS) investigators presented their interim analysis of the safety of carotid artery stenting versus endarterectomy in symptomatic patients in the February 26th early online publication of The Lancet. This multicenter randomized, controlled trial enrolled 1,713 patients (855 in the stenting arm; 858 in the endarterectomy arm). The primary outcome is fatal or disabling stroke in any territory at 3 years, which has yet to be analyzed. The interim safety analysis by intention-to-treat involved the 120-day rate of stroke, death, or procedural myocardial infarction.
According to the Lancet paper, at 120 days, 34 disabling strokes or deaths occurred in the carotid artery stenting (CAS) group compared with 27 (3.2%) in the carotid endarterectomy (CEA) group (hazard ratio [HR] 1.28, 95% CI 0.77–2.11).
In the CAS group, 72 (8.5%) strokes, deaths or procedural myocardial infarctions (MI) were recorded compared to 44 (5.2%) such events in the CEA group (p = 0.006). CAS showed a higher risk of any stroke (65 events for CAS vs. 35 for CEA) and all-cause mortality (19 for CAS vs. 7 for CEA). A total of 3 fatal procedural MIs occurred in the CAS group compared to 4 (non-fatal) MIs in the CEA group. Cranial nerve palsy occurred in 1 patient in the CAS group compared to 45 patients in the CEA group. In addition, the CAS group had fewer hematomas (31) than the CEA group (50).
According to the authors, CEA should remain the first-line therapy for those patients who are suitable for surgery until long-term follow-up data are available.
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Source: “Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial” International Carotid Stenting Study investigators (The Lancet February 26, 2010 early online publication; doi:10.1016/S0140-6736(10)60239-5)