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Cerebral protection devices for use during carotid artery angioplasty with stenting: A health technology assessment

Published online by Cambridge University Press:  27 February 2006

Devidas Menon
Affiliation:
University of Alberta
Tania Stafinski
Affiliation:
Institute of Health Economics

Abstract

Objectives: This study sought to examine the safety, efficacy, and economic implications of the use of cerebral protection devices during carotid artery angioplasty and stenting (CAS) in high-risk patients with severe carotid artery disease (CAD).

Methods: A comprehensive search for peer- and non–peer-reviewed studies that compared carotid endarterectomy (CEA) or CAS without cerebral protection to CAS with cerebral protection and appeared in the English language literature between January 1990 and January 2005 was completed. Information from studies identified was extracted using a common data abstraction form and then critically appraised against published quality assessment criteria.

Results: Of the eight studies found, six provided information on technical or procedural success rates, with values ranging from 95.6 percent to 100 percent. Three of the four studies comparing groups of patients who received CAS with cerebral protection with those who received only CAS reported a non-statistically significantly higher 30-day incidence of death and stroke (major or minor) in the latter group. None of the three studies comparing CAS with cerebral protection to CEA demonstrated a statistically significant difference in the 30-day incidence of death, major stroke, or myocardial infarction between treatment groups. No economic analyses were found.

Conclusions: In high-risk patients with severe CAD, the evidence suggests that CAS with cerebral protection may offer a safe and efficacious alternative to CEA, reducing the risk of embolic peri-procedural complications associated with CAS to acceptable levels.

Type
GENERAL ESSAYS
Copyright
© 2006 Cambridge University Press

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References

Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. 1991 North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. 325: 445453.
Bowser AN, Bandyk DF, Evans A, et al. 2003 Outcome of carotid stent-assisted angioplasty versus open surgical repair of recurrent carotid stenosis. J Vasc Surg. 38: 432438.Google Scholar
CARESS Steering Committee. 2003 Carotid revascularization using endarterectomy or stenting systems (CARESS): Phase 1 clinical trial. J Endovasc Ther. 10: 10211030.
Castriota F, Cremonesi A, Manetti R, et al. 2002 Impact of cerebral protection devices on early outcome of carotid stenting. J Endovasc Ther. 9: 786792.Google Scholar
Chalmers J, Chapman N. 2001 Progress in reducing the burden of stroke. Clin Exp Pharmacol Physiol. 28: 10911093.Google Scholar
Cohen JE, Lylyk P, Ferrario A, et al. 2003 Carotid stent angioplasty: The role of cerebral protection devices. Neurol Res. 25: 162168.Google Scholar
Diethrich E, Rodriguez-Lopez J, Ramaiah V, et al. 2001 Comparison of carotid angioplasty and stenting with and without cerebral protection. J Am Col Cardiol. 37 (Suppl A): 38A.Google Scholar
Downs SH, Black N. 1998 Assessing the quality of nonRCTs. J Epidemiol Community Health. 52: 377384.Google Scholar
Fields WS, Maslenikov V, Meyer JS, et al. 1970 Joint study of extracranial arterial occlusion: V. Progress report of prognosis following surgery or nonsurgical treatment for transient cerebral ischemic attacks and cervical carotid artery lesions. JAMA. 211: 19932003.Google Scholar
Finlay JM. 2004. Capital Health Region. Edmonton, Alberta. Available at: www.capitalhealth.ca. Accessed March 6
Hobson RW. 2003 Rationale and status of randomized controlled clinical trials in carotid artery stenting. Semin Vasc Surg. 16: 311316.Google Scholar
Jovell AJ, Navarro-Rubio MD. 1995 Evaluacion de la evidencia cientifica. Med Clin (Barc). 105: 740743.Google Scholar
Kasirajan K, Schneider PA, Kent KC. 2003 Filter devices for cerebral protection during carotid angioplasty and stenting. J Endovasc Ther. 10: 10391045.Google Scholar
Kastrup A, Groschel K, Krapf H, et al. 2003 Early outcome of carotid angioplasty and stenting with and without cerebral protection devices. Stroke. 34: 813819.Google Scholar
Kastrup A, Schulz J, Raygrotzki S, et al. 2004 Comparison of angioplasty and stenting with cerebral protection versus endarterectomy for treatment of internal carotid artery stenosis in elderly patients. J Vasc Surg. 40: 945951.Google Scholar
Kilaru S, Korn P, Kasirajan K, et al. 2003 Is carotid angioplasty and stenting more cost effective than carotid endarterectomy? J Vasc Surg. 37: 331339.Google Scholar
Macdonald S, McKevitt F, Venables G, et al. 2002 Neurological outcomes after carotid stenting protected with the NeuroShield filter compared to unprotected stenting. J Endovasc Ther. 9: 777785.Google Scholar
Mayberg MR, Wilson SE, Yatsu F, et al. 1991 Carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis. Veterans Affairs Cooperative Studies Program 309 Trialist Group. JAMA. 266: 32893294.Google Scholar
McKevitt FM, Macdonald S, Venables GS, et al. 2004 Complications following carotid angioplasty and carotid stenting in patients with symptomatic carotid artery disease. Cerebrovasc Dis. 17: 2834.Google Scholar
MRC European Carotid Surgery Trial. 1991 Interim results for symptomatic patients with severe (70–99%) or with mild (0–29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet. 337: 12351243.
Mukherjee D, Yadav JS. 2000 Carotid and cerebrovascular disease. Cardiol Rev. 8: 322332.Google Scholar
Murray CJ, Lopez AD. 1996. The global burden of disease: A comprehensive assessment of mortality and disability from diseases, injuries and risk factors in 1990 and projected to 2020. Vol. 1. Cambridge, MA: Harvard School of Public Health on behalf of the World Health Organization and the World Bank;
Ohki T, Veith FJ. 2000 Nature and implications of different types of carotid plaque. Tech Interv Vasc Radiol. 13: 144152.Google Scholar
Ohki T, Veith FJ. 2001 Carotid artery stenting: Utility of cerebral protection devices. J Invasive Cardiol. 13: 4755.Google Scholar
Sievert H, Rabe K. 2002 Role of distal protection during carotid stenting. J Interv Cardiol. 15: 499504.Google Scholar
Wholey MH, Jarmolowski CR, Eles G, et al. 1997 Endovascular stents for carotid artery occlusive disease. J Endovasc Surg. 4: 326338.Google Scholar
Wielgosz A, Arango M, Johansen H, et al. 2003. The growing burden of heart disease and stroke in Canada 2003. Ontario: Heart and Stroke Foundation of Canada;
World Health Organization (WHO). 2000. The World Health Report 2000. Geneva: WHO;
Yadav JS, Wholey MH, Kuntz RE, et al. 2004 Protected carotid artery stenting versus endarterectomy in high risk patients. N Engl J Med. 351: 14931501.Google Scholar
Zahn R, Mark B, Niedermaier N, et al. 2004 Embolic protection devices for carotid artery stenting: Better results than stenting without protection? Eur Heart J. 25: 15501558.Google Scholar