New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis
New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis
Background and purpose. Even if periprocedural cerebral microembolism associated with carotid
 endarterectomy or stenting usually does not manifest as clinically overt stroke,
 neuropsychological disturbances resulting from these events represent an important clinical
 and socioeconomic problem. Still, it remains unclear whether the use proximal protection can
 lower the incidence of cerebral embolism associated with the treatment of carotid stenosis.

 Materials and methods. This was a prospective randomised single-centre study, which was aimed
 at comparison of surgical eversion endarterectomy with stenting under proximal protection in
 symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions
 revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment
 and neurologic events.
The CARECarotid was a prospective randomised single-centre study, which was performed in the
 University Hospital in Kraków. It was planned to evaluate 50 patients presenting with
 symptomatic lesions of the internal carotid artery.

 Patients were randomly assigned to one of the two treatment arms: surgical endarterectomy or
 carotid angioplasty with stenting under proximal protection. All patients provided their
 written informed consent to undergo the procedures and to participate in this trial.

 In all surgical patients carotid endarterectomy will perform using the eversion technique.
 All surgical endarterectomies will perform under cervical block anaesthesia.

 Perioperatively patients in the surgical arm received aspirin; other antiplatelet or
 anticoagulant agents were not administered during 5 days before surgery.

 All procedures in carotid artery stenting will perform with proximal protection system - the
 Mo.Ma (Medtronic, Minneapolis, MN, USA) device. The investigators will implante stents that
 were tailored to the localisation of lesions and morphology of carotid arteries: Carotid
 Wallstent (Boston Scientific, Natick, MA, USA, and in patients with tortuous arteries Precise
 Pro RX (Cordis, Fremont, CA, USA) or Roadsaver (Terumo, Tokyo, Japan). Patients in the stent
 arm will receive clopidogrel 75 mg/day and aspirin 75 mg/day. These drugs were administered
 during 3 days before planned procedure and then 3-6 months after stent implantation. All
 patients will have MRI DWI performed before and 2-4 days after procedures in both groups.
 Within 6 months there will be an evaluation of the incidence of neurological events.
Inclusion criteria comprised:

 -  patient's age ≥ 18 years;

 -  60-99% stenosis of the internal carotid artery (degree of stenosis assessed by means
 of Doppler sonography, CT angiography or catheter angiography);

 -  diameter of the target internal carotid artery not more than 7 mm;

 -  symptomatic lesion (a history of ipsilateral stroke, transient ischaemic attack or
 reversible ischaemic neurological deficit);

 -  localisation and morphology of the lesion making possible surgical eversion
 endarterectomy or endovascular angioplasty with stent implantation;

 -  written informed consent.

 Exclusion criteria comprised:

 -  target lesion that has been previously stented;

 -  highly calcified lesions;

 -  very tortuous common and internal carotid arteries;

 -  occlusion of the contralateral carotid artery without adequate collateral circulation
 through the circle of Willis (revealed by means of transcranial Doppler sonography);

 -  anatomical contraindications for eversion endarterectomy;

 -  acute ipsilateral stroke;

 -  disabling stroke at any side;

 -  other severe pathologies of the brain resulting is significant loss of cerebral tissue
 and/or significant neurological deficits, such as extensive previous stroke or
 multiple lacunar infarcts;

 -  history of haemorrhagic transformation of ischaemic stroke;

 -  severe comorbidities (such as cancer or decompensated heart failure);

 -  allergy to aspirin, clopidogrel or ticlopidine;

 -  allergy to iodinated contrast media;

 -  pregnant women;

 -  women of reproductive age who do not use effective contraception;

 -  metallic implants (such as peacemakers and orthopaedic endoprostheses) or other known
 contraindications for magnetic resonance imaging;