Ruffino  et al. CVIR 2016

Featured product: Roadsaver™ Carotid Artery Stent

August 29, 2016

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This study examines the incidence of new ischemic brain lesions after carotid artery stenting (CAS) with the dual-layer micromesh Roadsaver^TM carotid artery stent, measured by the Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI).

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• Prospective, Single-arm, Single-center

  • Enrolment between September 2015 - January 2016 at a high-volume Italian center

• 23 consecutive patients (Mean age: 74 ± 7, 19 (82.6%) males)

• Principal inclusion criteria were 18 or more years of age and carotid artery stenosis

  • 60.9 % (14) Symptomatic patients, with ≥50% evaluated by duplex ultrasound (DUS) according to the NASCET criteria
  • 39.1 % (9)   Asymptomatic patients, with ≥80% and suitable for treatment according to the vascular and neurological specialist

• Patients were scheduled for DW-MRI evaluations at baseline, 24 h and 30 days post-stenting, and clinical evaluation and DUS at baseline, 24 h, 30 days, and 6 months post-stenting

• The clinical evaluation included a neurological examination performed by an independent neurologist using the National Institute of Health Stroke Scale (NIHSS) and cognitive tests as the Mini-Mental State Examination and the Frontal Assessment Battery

• Procedural success was defined as stenting achieving <30 % residual stenosis with no complications

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• The intracranial circulation was visualized before and after the procedurę.

• Co-medication:

  • Before the procedure, all patients received dual antiplatelet therapy (DAPT; i.e. 100 mg acetyl-salicylic acid (ASA) and a loading dose of 375 mg clopidogrel (unless already on DAPT)).
  • During the procedure, ACT-based heparinization was administered using weight adjusted initial dosing. 1 mg of atropine was administered after stent dilatation.
  • After the procedure, patients received a daily dose of DAPT (100 mg ASA and 75 mg clopidogrel) for one month, and only ASA thereafter.

• Embolic protection device (EPD) use: 100%

  • Emboshield, Abbott Vascular in all patients

• The same 2 operators with extensive experience (50 CAS/year as first operators in last 10 years) performed all procedures.

• All MRI studies were performed with a 1.5 T scanner (Achieva, Philips, Best, The Netherlands).

  • For a detailed summary of different imaging parameters and related analyses, see the original manuscript.

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• The pre-procedural DW-MRI did not detect any acute ischemic lesions in any patient.

• In 7/23 (30.4 %) patients the 24-h post-procedure imaging showed new asymptomatic (silent) ischemic cerebral lesions (4/7 stand-alone ipsilateral & 3/7 with additional contralateral lesions).

  • 15 new ipsilateral (median volume 0.076 cm3) ischemic lesions
  • 6 contralateral (median volume 0.044 cm3) ischemic lesions

• The number of ipsilateral lesions in a single patient ranged from 1 to 4 (median 3 lesions/patient).

• No statistically significant differences in the baseline (presence of risk factors) nor in the procedure management was detected among patients with and w/o the post-CAS cerebral embolization.

• Most lesions were found in symptomatic patients (73 %) and in patients presenting with unstable plaques.

• The 30-day imaging showed complete resolution of all lesions and no new ischemic lesions.

• Follow-up clinical and ultrasound examinations at 30 days and 6 months recorded no adverse cardiac or cerebrovascular events, while the ECA was patent in all cases.

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• Protected stenting with a dual-layer micromesh Roadsaver^TM stent shows good safety and efficacy in the treatment of carotid stenosis.
• The incidence of new ischemic brain lesions after CAS with the Roadsaver stent indicates that this stent may exert intrinsic embolic protection and positively impact outcomes.

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