Carotid angioplasty is an alternative therapeutic option to carotid endarterectomy for a defined group of patients

Abstract

Stroke is the third cause of death and the leading cause of disability worldwide. In the United States approximately 795000 cases of stroke are produced annually with a mortality rate of 17%. (1) Atherosclerotic disease of the extracranial internal carotid artery (ICA) is responsible for 20% to 25% of all ischemic strokes, and both medical therapy (MT) and carotid endarterectomy (CE) have been previously used to prevent them. Medical therapy is currently considered the first choice in the treatment of asymptomatic patients with ≤ 80% carotid obstruction. Regarding CE, both American and European guidelines recommend its use in symptomatic patients with stenosis between 70 % and 99% (Class I, level of evidence A). Carotid percutaneous transluminal angioplasty (PTA) is the third therapeutic option which started to be used 15 years ago and several randomised studies have attempted to better define its role with respect to MT and CE. CAVATAS (2) was the first multicentric, randomised study, which included 504 patients with symptomatic carotid artery disease for PTA and CE. There were no significant differences between both treatments in the endpoint of death or stroke at 30 days (10%) and at 3 years (14%). The surgical team had a greater rate of cranial nerve paralysis (CE: 8.7%, PTA: 0%; p < 0.0001). No cerebral protection (CP) system was employed and stenting was used only in 26% of the cases. SAPPHIRE (3) included 334 symptomatic and asymptomatic (70%) patients with high risk surgical criteria. According to protocol, CP was used in all PTA patients. The primary endpoint of death, stroke or acute myocardial infarction (AMI) at 30 days plus ipsilateral stroke or death due to neurological causes between 31 days and 1 year occurred in 12.2% of the PTA group patients and 20.1% of the CE group patients (p = 0.004 for noninferiority and p = 0.05 for superiority). The rates of stroke and death at 30 days were similar in both groups and in the CE group there was a greater proportion of infarction (6.6% vs. 1.9%; p = 0.04) and cranial nerve paralysis (5.3% vs. 0%; p = 0.003). SPACE (4) and EVA-3S (5) published in 2006, were multicentric, randomised and noninferiority studies. The SPACE study enrolled 1200 symptomatic patients and CP was used in 27% of the PTA group patients. The primary endpoint of ipsilateral stroke or death from any cause at 30 days, occurred in 41 patients of the PTA group (6.84%) and in 37 patients in the CE group (6.34%) (absolute difference 0.51%; p = 0.09 for noninferiority). No significant differences were found for death, global stroke, non-fatal ipsilateral ischemic stroke, disabling stroke and nonfatal ipsilateral intracerebral bleeding. Even though the SPACE study could not prove noninferiority of PTA compared with CE, the difference between both treatments was of only four events in almost 600 patients treated per group.