3. What are the guidelines for the prevention of stroke in adults diagnosed with carotid artery atherosclerosis?

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1 Title: Carotid Stenting versus Carotid Endarterectomy for the Management of Carotid Artery Atherosclerosis: Clinical and Cost-effectiveness and Guidelines for Use Date: 05 August 2008 Research question: 1. What is the clinical effectiveness of carotid stenting versus carotid endarterectomy for the prevention of stroke in adults diagnosed with carotid artery atherosclerosis? 2. What is the cost-effectiveness of carotid stenting versus carotid endarterectomy for the prevention of stroke in adults diagnosed with carotid artery atherosclerosis? 3. What are the guidelines for the prevention of stroke in adults diagnosed with carotid artery atherosclerosis? Methods: A limited literature search was conducted on key health technology assessment resources, including PubMed, the Cochrane Library (Issue 3, 2008), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, EuroScan, international HTA agencies, and a focused Internet search. Results include articles published between 2003 and July 2008, and are limited to English language publications only. Filters were applied to limit the retrieval to systematic reviews, health technology assessments, meta analyses, guidelines, economic evaluations, and randomized controlled trials. Internet links are provided, where available. Results: HTIS reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews and meta-analyses are presented first. These are followed by economic evaluations, randomized controlled trials (RCTs), observational studies and evidence-based guidelines. Eleven systematic reviews and meta-analyses, three economic evaluations, six RCTs and four guidelines were identified pertaining to the clinical and cost-effectiveness of carotid stenting Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 versus carotid endarterectomy for the prevention of stroke in adults diagnosed with carotid artery atherosclerosis. Additional information that may be of interest, including a sub-analysis of an included RCT, can be found in the Appendix. Health technology assessments No literature identified. Systematic reviews and meta-analyses 1. Brahmanandam S, Ding EL, Conte MS, Belkin M, Nguyen LL. Clinical results of carotid artery stenting compared with carotid endarterectomy. J Vasc Surg 2008;47(2): PubMed: PM Guzman LA, Costa MA, Angiolillo DJ, Zenni M, Wludyka P, Silliman S, et al. A systematic review of outcomes in patients with staged carotid artery stenting and coronary artery bypass graft surgery. Stroke 2008;39(2): PubMed: PM Jeng JS, Liu HM, Tu YK. Carotid angioplasty with or without stenting versus carotid endarterectomy for carotid artery stenosis: A meta-analysis. J Neurol Sci 2008;270(1-2):40-7. PubMed: PM Murad MH, Flynn DN, Elamin MB, Guyatt GH, Hobson RW, Erwin PJ, et al. Endarterectomy vs stenting for carotid artery stenosis: A systematic review and metaanalysis. J Vasc Surg 2008;48(2): PubMed: PM Ringleb PA, Chatellier G, Hacke W, Favre JP, Bartoli JM, Eckstein HH, et al. Safety of endovascular treatment of carotid artery stenosis compared with surgical treatment: a meta-analysis. J Vasc Surg 2008;47(2): PubMed: PM Schnaudigel S, Groschel K, Pilgram SM, Kastrup A. New brain lesions after carotid stenting versus carotid endarterectomy: a systematic review of the literature. Stroke 2008;39(6): PubMed: PM Wiesmann M, Schopf V, Jansen O, Bruckmann H. Stent-protected angioplasty versus carotid endarterectomy in patients with carotid artery stenosis: meta-analysis of randomized trial data. Eur Radiol PubMed: PM Ederle J, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. Cochrane Database Syst Rev 2007;(4):CD PubMed: PM Luebke T, Aleksic M, Brunkwall J. Meta-analysis of randomized trials comparing carotid endarterectomy and endovascular treatment. Eur J Vasc Endovasc Surg 2007;34(4): PubMed: PM Coward LJ, Featherstone RL, Brown MM. Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence. Stroke 2005;36(4): PubMed: PM Management of Carotid Artery Atherosclerosis 2

3 11. Qureshi AI, Kirmani JF, Divani AA, Hobson RW. Carotid angioplasty with or without stent placement versus carotid endarterectomy for treatment of carotid stenosis: a metaanalysis. Neurosurgery 2005;56(6): PubMed: PM Economic analyses and cost information 12. Park B, Mavanur A, Dahn M, Menzoian J. Clinical outcomes and cost comparison of carotid artery angioplasty with stenting versus carotid endarterectomy. J Vasc Surg 2006;44(2): PubMed: PM [Endovascular treatment of carotid stenosis]. In: Belgian Health Care Knowledge Centre (KCE) [website] [KCE Reports 13]. Brussels: Belgian Health Care Knowledge Centre; Available: Note: English portion begins on page Kilaru S, Korn P, Kasirajan K, Lee TY, Beavers FP, Lyon RT, et al. Is carotid angioplasty and stenting more cost effective than carotid endarterectomy? J Vasc Surg 2003;37(2): PubMed: PM Randomized controlled trials 15. Gurm HS, Yadav JS, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, et al. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med 2008;358(15): PubMed: PM Steinbauer MG, Pfister K, Greindl M, Schlachetzki F, Borisch I, Schuirer G, et al. Alert for increased long-term follow-up after carotid artery stenting: results of a prospective, randomized, single-center trial of carotid artery stenting vs carotid endarterectomy. J Vasc Surg 2008;48(1):93-8. PubMed: PM Mas JL, Chatellier G, Beyssen B, Branchereau A, Moulin T, Becquemin JP, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355(16): PubMed: PM Ringleb PA, Allenberg J, Bruckmann H, Eckstein HH, Fraedrich G, Hartmann M, et al. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial. Lancet 2006;368(9543): PubMed: PM Brooks WH, McClure RR, Jones MR, Coleman TL, Breathitt L. Carotid angioplasty and stenting versus carotid endarterectomy for treatment of asymptomatic carotid stenosis: a randomized trial in a community hospital. Neurosurgery 2004;54(2): PubMed: PM Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351(15): PubMed: PM Management of Carotid Artery Atherosclerosis 3

4 Guidelines and recommendations 21. Canadian Stroke Network, Heart and Stroke Foundation of Canada. Canadian best practice recommendations for stroke care: 2006 [Canadian stroke strategy]. Ottawa: Canadian Stroke Network; Available: See section 3.7: Carotid intervention 22. SCAI/SVMB/SVS clinical competence statement on carotid stenting: training and credentialing for carotid stenting - multispecialty consensus recommendations. Vasc Med 2005;10(1): PubMed: PM Carotid artery stenting. In: California Technology Assessment Forum (CTAF) [website]. San Francisco: California Technology Assessment Forum; Available: Barr JD, Connors JJ, III, Sacks D, Wojak JC, Becker GJ, Cardella JF, et al. Quality improvement guidelines for the performance of cervical carotid angioplasty and stent placement. Developed by a collaborative panel of the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, and the Society of Interventional Radiology. J Vasc Interv Radiol 2003;14(9 Pt 1): PubMed: PM Prepared by: Kristen Moulton, B.A., Research Assistant Charlene Argáez, M.L.I.S., Information Specialist Health Technology Inquiry Service htis@cadth.ca Tel: Management of Carotid Artery Atherosclerosis 4

5 Appendix Further information: Sub-analysis of included RCT 25. Stingele R, Berger J, Alfke K, Eckstein HH, Fraedrich G, Allenberg J, et al. Clinical and angiographic risk factors for stroke and death within 30 days after carotid endarterectomy and stent-protected angioplasty: a subanalysis of the SPACE study. Lancet Neurol 2008;7(3): PubMed: PM Reviews 26. Seretis K, Goudakos I, Vlachakis I, Anthimidis G, Papadimitriou D. Carotid artery disease in octogenarians: endarterectomy or stenting? Int Angiol 2007;26(4): PubMed: PM Carotid, vertebral and intracranial artery angioplasty and stenting. In: ICSI [website] [Technology assessment #93]. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); Available: active/carotid vertebral_and_intracranial_artery_angioplasty_and_stenting_2.html Additional references 28. Embolic stenting with embolic protection for carotid artery stenosis. In: HTAIS Custom Hotline Response [database online]. Plymouth Meeting (PA): ECRI Institute; Note: Paid subscription to ECRI required 29. Biasi GM, Froio A, Deleo G, Lavitrano M. Indication for carotid endarterectomy versus carotid stenting for the prevention of brain embolization from carotid artery plaques: in search of consensus. J Endovasc Ther 2006;13(5): PubMed: PM Mas JL, Chatellier G, Beyssen B. Carotid angioplasty and stenting with and without cerebral protection: clinical alert from the Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S) trial. Stroke 2004;35(1):e18-e20. PubMed: PM Management of Carotid Artery Atherosclerosis 5