Eversion versus conventional endarterectomy in females as secondary prevention of stroke caused by carotid stenosis: a randomized, controlled trial

Abstract

BACKGROUND: Stroke is one of the leading causes of death worldwide and the first cause of long-term morbidity in western world. In our country, it’s the first cause of death in females over 65 years. The main risk factor to develop an ischemic stroke is the presence of an atherosclerotic plaque in the wall of the carotid artery. It has been shown that, by sex, there are different anatomopathological characteristics in the atheroma plaques and in the size and diameter of the arteries. These influence the risk of stroke and could also explain why the treatment proposed so far do not benefit females as much as men. In addition, we must keep in mind that the current guidelines for the treatment of stenosis are based on studies where females are underrepresented. Because of this, although largest meta-analysis comparing e-CEA with c-CEA do not show significant differences, we cannot discard the idea that e-CEA may have advantages in females. OBJETIVES: To compare the proportion of postoperative ischemic strokes in the first 30 days after conventional endarterectomy or eversion in females. They undergo it as secondary prevention of an ischemic stroke caused by carotid stenosis. Secondary objectives are to evaluate and compare: total procedure time, mortality within the first 30 days, restenosis of the carotid artery, occurrence of long-term ischemic stroke, onset of hypertension/hypotension after surgery, development of a carotid pseudoaneurysm. DESING: A multicenter randomized controlled single-blind with external blind review clinical trial will be carried out in 7 hospitals through Catalonia, conducted between 2019 and 2023. We will use a non-probabilistic, consecutive and proportional sampling. PARTICIPANTS: Females that undergo an endarterectomy, as secondary prevention after suffer an ischemic stroke with significant carotid stenosis, in the hospitals included in our study. The study will include 396 participants