Key result
Carotid revascularization with Protégé GPS and Spider systems achieves 100% procedural success in high-risk patients.
Why the study?
Patients with severe carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy, necessitating evaluation of alternative revascularization methods.
Is percutaneous carotid artery revascularization with the Protégé GPS stent and Spider distal embolic protection system feasible and safe in high-risk patients with severe carotid stenosis?
Is percutaneous carotid artery revascularization with the Protégé GPS stent and Spider distal embolic protection system feasible and safe in high-risk patients with severe carotid stenosis?
Carotid stenting with the Protégé GPS stent and Spider distal embolic protection system is feasible in high-risk patients, supporting further evaluation in a large multicenter trial.
Answers are grounded in this paper and cite their sources.
Supports feasibility of new carotid stenting system in high-risk patients; leaves open whether it reduces stroke risk versus endarterectomy.
The purpose of this study was to evaluate the feasibility of carotid artery revascularization using a new system for carotid stenting and distal embolic protection in 30 patients with severe carotid stenosis and high risk for carotid endarterectomy (Carotid Revascularization With ev3 Arterial Technology Evolution, or CREATE). Previous studies suggest that patients with carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy. All patients underwent percutaneous revascularization using the Protégé GPS self-expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). In-hospital and 30-day outcomes were analyzed. High-risk features included age > 75 years (63%), left ventricular ejection fraction < 35% (20%), and restenosis after prior carotid endarterectomy (53%). Procedural success was 100%. In-hospital complications included severe vasovagal reactions in six patients (20%) and a popliteal embolus in one patient (3.3%), treated by successful embolectomy. During 30 days of follow-up, two patients (6.6%) experienced minor neurological deficits, including transient expressive aphasia that resolved without therapy in one patient and homonymous hemianopsia due to contralateral posterior circulation stroke in one patient. This study supports the feasibility of percutaneous carotid artery revascularization with the Protégé GPS self-expanding stent and Spider distal embolic protection system, which will be evaluated in a large multicenter pivotal trial (CREATE Pivotal Trial).
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Safian et al. (2004) studied Severe carotid stenosis and high risk for carotid endarterectomy (n=30). Protégé GPS self-expanding stent and Spider distal embolic protection system was evaluated on Procedural success. Percutaneous carotid artery revascularization using the Protégé GPS stent and Spider distal embolic protection system achieved 100% procedural success in high-risk patients.
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