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Title: Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial

PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResultsmore » through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.« less
Authors:
 [1] ;  [2] ;  [3] ;  [4] ;  [5] ;  [6]
  1. A.Z. Sint-Blasius, Department of Vascular Surgery (Belgium)
  2. Park Hospital, Center for Vascular Medicine-Angiology and Vascular Surgery (Germany)
  3. Klinikum Dortmund GmbH (Germany)
  4. Sankt Gertrauden-Krankenhaus (Germany)
  5. Klinikum Neuperlach (Germany)
  6. One Boston Scientific Place, Boston Scientific Corporation (United States)
Publication Date:
OSTI Identifier:
22470033
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 38; Journal Issue: 2; Conference: BSIR 2014: Britisch Society of Interventional Radiology 2014 annual meeting, Liverpool (United Kingdom), 12-14 Nov 2014; Other Information: Copyright (c) 2015 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); http://www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CAROTID ARTERIES; COMPARATIVE EVALUATIONS; DEATH; HAZARDS; MYOCARDIAL INFARCTION; PATIENTS; SAFETY; SURGERY