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Carotid stenting with a new system for distal embolic protection and stenting in high-risk patients: the carotid
Robert D Safian1, J Michael Bacharach, Gary M Ansel
1Division of Cardiology, William Beaumont Hospital, Royal Oak, Michigan 48073, USA. rsafian@beaumont.edu
Insights
This study shows that carotid artery stenting with distal embolic protection is feasible for high-risk patients. The CREATE trial demonstrated a 100% procedural success rate for this minimally invasive approach.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Neurology
Background:
- Severe carotid stenosis poses a significant stroke risk.
- Carotid endarterectomy is high-risk for patients with comorbidities.
- Percutaneous revascularization offers an alternative for these patients.
Purpose of the Study:
- To assess the feasibility of carotid stenting with distal embolic protection in high-risk patients.
- To evaluate the CREATE (Carotid Revascularization With ev3 Arterial Technology Evolution) system.
- To analyze in-hospital and 30-day outcomes of the procedure.
Main Methods:
- 30 high-risk patients with severe carotid stenosis underwent stenting.
- Protégé GPS stent and Spider distal embolic protection system were used.
- In-hospital and 30-day outcomes were meticulously analyzed.
Main Results:
- 100% procedural success was achieved.
- Low rates of in-hospital complications (vasovagal reactions, popliteal embolus).
- Two patients (6.6%) experienced minor, transient neurological deficits within 30 days.
Conclusions:
- Percutaneous carotid artery revascularization with the Protégé GPS stent and Spider system is feasible.
- This approach is suitable for patients at high risk for carotid endarterectomy.
- Results support further evaluation in the CREATE Pivotal Trial.
Abstract:
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).