CLINICAL STUDY: INTERVENTIONAL CARDIOLOGY
Multicenter evaluation of carotid artery stenting with a filter protection system
Nadim Al-Mubarak, MD, FACC*,
Antonio Colombo, MD, FACC ,
Peter A. Gaines, MD ,
Sriram S. Iyer, MD, FACC*,
Nicola Corvaja, MD,
Trevor J. Cleveland, MD,
Sumaira Macdonald, MD,
Cristina Brennan, MD* and
Jiri J. Vitek, MD, PhD*,*
* Lenox Hill Heart and Vascular Institute, New York, New York, USA
Centro Cuore Colombus-Interventional Cardiology, Milan, Italy
Sheffield Vascular Institute, Sheffield, United Kingdom
Manuscript received September 13, 2001;
revised manuscript received December 4, 2001,
accepted December 14, 2001.
* Reprint requests and correspondence: Dr. Jiri J. Vitek, 130 East 77th Street, New York, New York 10021 USA.
Jvitek{at}lenoxhill.net
OBJECTIVES: The aim of this study was to evaluate the feasibility and safety of carotid artery stenting (CAS) with a filter protection system.
BACKGROUND: Neurologic events linked to the embolization of particulate matter to the cerebral circulation may complicate CAS. Strategies designed to capture embolic particles during carotid intervention are being evaluated for their efficacy in reducing the risk of these events.
METHODS: Between September 1999 and July 2001, a total of 162 patients (164 hemispheres) underwent CAS with filter protection (NeuroShield, MedNova Ltd., Galway, Ireland) according to prospective protocols evaluating the filter system at three institutions.
RESULTS: Angiographic success was achieved in 162 of the procedures (99%) and filter placement was successful in 154 (94%) procedures. Carotid access was unsuccessful in two cases (1%) and filter placement in eight cases (5%). Of the latter, five procedures were completed with no protection and three were completed using alternative protection devices. On an intention-to-treat basis, the overall combined 30-day rate of all-stroke and death was 2% (four events: two minor strokes and two deaths). This includes one minor stroke in a patient with failed filter placement and CAS completed without protection. There was one cardiac arrhythmic death and one death from hyperperfusion-related intracerebral hemorrhage. There were no major embolic strokes.
CONCLUSIONS: Carotid artery stenting with filter protection is technically feasible and safe. Early clinical outcomes appear to be favorable and need to be confirmed in a larger comparative study.
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Abbreviations and Acronyms
| | CREST | | CAS | | carotid artery stenting | | CEA | | carotid endarterectomy | | CREST | | Carotid Revascularization Endarterectomy vs. Stenting Trial | | ECA | | external carotid artery | | ICA | | internal carotid artery | | NIHSS | | National Institutes of Health Stroke Score | | TCD | | transcranial Doppler |
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