Clinical Evidence in Carotid Artery Stenosis Treatment and Subjects for Further Study

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1 Clinical Evidence in Carotid Artery Stenosis Treatment and Subjects for Further Study Mitsuhito Mase, M.D., Ph.D. 1, Hiroyuki Katano, M.D., Ph.D. 1, Yusuke Nishikawa, M.D., Ph.D. 1, Kazuo Yamada, M.D., Ph.D. 1 1 Department of Neurosurgery, Nagoya City University Graduate School of Medical Sciences Carotid endarterectomy CEA is an established surgical treatment for carotid stenosis. Recently, carotid artery stenting CAS has become aveilable as an alternative for treating the disease. However, which surgical method is the better choice is still controversial. Recent developments in medical treatment have brought remarkable improvement in the outcome of carotid stenosis. It is therefore time to reconsider the guidelines for carotid stenosis treatment based on the updated clinical evidence. Received June 12, 2013 accepted June 24, 2013 Key words carotid artery stenosis, carotid endarterectomy, carotid artery stenting, medical treatment Jpn J Neurosurg Tokyo , 2013 /carotid endarterectomy CEA carotid artery stenting CAS Table 1 CEA CAS CEA CAS study CAS CEA CAS CEA 1 NASCET North American Carotid Endarterectomy Trial 3 4 RCT randomized controlled trial transient ischemic attack TIA nondisabling stroke 120 2,885 best medical treatment best medical treatment plus CEA Address reprint requests to Mitsuhito Mase, M.D., Ph.D., Department of Neurosurgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho cho, Mizuho ku, Nagoya shi, Aichi , Japan 671

2 Table 1 Randomized controlled trials for the treatment of carotid stenosis Trials NASCET ECST ACAS ACST SAPPHIRE EVA 3S SPACE ICSS CREST ACST 2 Asymptomatic Asymptomatic Asymptomatic Both Both Asymptomatic Treatments Published year start The treatment which has significantly better results is under lined p p CEA CEA CEA 20 2 ECST European Carotid Surgery Trial RCT nondisabling stroke TIA 6 3,024 CEA p p CEA 1 ACAS The Asymptomatic Carotid Atherosclerosis Study 9 RCT 60 1,662 CEA 5 CEA CEA p nondisabling stroke disabling stroke 2 ACST Asymptomatic Carotid Surgery Trial 11 RCT ,120 CEA CEA CEA 6 5 CEA CEA p CEA CEA 60 CEA ACAS ACST 3 RCT 5,223 CEA 3 30 CEA

3 2.9 CEA 3 5 CEA CAS 1 SAPPHIRE Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy study 10,27 RCT CEA high risk 334 CAS CEA 6 Smart Precise protection device Angioguard Angioguard XP CAS CAS 12.2 CEA 20.1 p 0.05 CAS p CAS p CAS 70.1 CEA EVA 3S Endarterectomy Versus Angioplasty in Patients with Severe Carotid Stenosis trial 16 RCT 60 CEA low risk 527 CAS CEA 5 7 protection device study protection device 91.9 CEA 25 CAS 12 CAS CEA CAS CEA CAS protection device protection device 12 3 SPACE Stent Protected Angioplasty versus Carotid Endarterectomy trial 25 RCT 50 CEA low risk 1,200 CAS CEA CAS CEA protection device 2730 CAS 6.84 CEA 6.34CAS CAS CEA protection device 4 ICSS International Carotid Stenting Study ,713 RCT CAS CEA CAS CEA protection device CAS CAS 8.5 CEA 5.2 p protection device CAS 12 5 CREST Carotid Revascularization Endarterectomy versus Stent Trial 5 RCT CEA low risk 2,502 CAS CEA CEA CAS CREST Interventional Management Committee device Acculink Accunet system protection device 4 CAS 7.2 CEA 6.8 CAS CAS 4.1 CEA 2.3 p 0.01 CEA 673

4 Hazard ratio for primary end point with CAS CEA better 1 0 CAS better Age yr Fig. 1 Hazard ratio for primary end point with CAS reprinted from Brott TG, et al., CAS 1.1 CEA 2.3 p 0.03 CAS 2.0 CEA 2.4 p 0.85 CAS CEA CAS CAS 5.5 CEA 3.2 p 0.04 p 0.15 p CAS 70 CEA Fig. 1 CEA low risk CAS CEA CREST 2 quality of life QOL QOL 26 CEA p NASCET 70 A B CEA 60 CEA B CAS CEA SAPPHIRE CREST CEA CAS CEA class recommendation CAS CAS class recommendation 70 class a recommendation CEA CAS class a recommendation CAS class b recommendation 1 Table ACAS CEA ACBS Asymptomatic Cervical Bruit Study 14 ACAS 1 15 CEA

5 Table 2 Annual ipsilateral stroke rates of patients with asymptomatic severe 50 carotid stenosis managed with medical intervention alone reprinted with modification from Abbott AL, Study Publication year Sample size Ipsilateral stroke rate year Johnson Toronto VACS ACAS ECST ACBS CHS NASCET ACSRS ASED SMART Natural history of asymptomatic carotid plaque Outcome in patients with asymptomatic neck bruits The Veterans Affairs Cooperative Study Group Asymptomatic Carotid Atherosclerosis Study European Carotid Surgery Trial Asymptomatic Cervical Bruit Study The Cardiovascular Health Study North American Carotid Endarterectomy Trial Asymptomatic Carotid Stenosis and Risk of Stroke Study Asymptomatic Stenosis Embolus Detection Study Second Manifestations of Arterial Disease Study CEA CAS CEA RCT CAS RCT CEA CEA NASCET EVA 3S CREST CEA 1 transcranial doppler TCD MRA oxygen extraction fraction OEF PET severe metabolic compromise 23 CEA CAS RCT CEA high risk CAS high risk CEA CAS Asymptomatic Carotid Surgery Trial 2 ACST QOL 5, CASTER Carotid Asymptomatic Stenosis Registry 50 CEA CAS

6 CEA CAS CEA CAS CAS CEA CEA CAS device CAS protection device CREST update 1 Abbott AL Medical nonsurgical intervention alone is now best for prevention of stroke associated with asymptomatic severe carotid stenosis results of a systematic review and analysis. Stroke 40 e573 e583, Amarenco P, Labreuche J, Mazighi M Lessons from carotid endarterectomy and stenting trials. Lancet , Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG, Haynes RB, Rankin RN, Clagett GP, Hachinski VC, Sackett DL, Thorpe KE, Meldrum HE, Spence JD Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Carotid Endarterectomy Trial Collaborators. N Engl J Med , Beneficial effect of carotid endarterectomy in symptomatic patients with high grade carotid stenosis. North American Carotid Endarterectomy Trial Collaborators. N Engl J Med , Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet AJ, Howard VJ, Moore WS, Voeks JH, Hopkins LN, Cutlip DE, Cohen DJ, Popma JJ, Ferguson RD, Cohen SN, Blackshear JL, Silver FL, Mohr JP, Lal BK, Meschia JF CREST Investigators Stenting versus endarterectomy for treatment of carotid artery stenosis. N Engl J Med , Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ American College of Cardiology Foundation American Heart Association Task Force on Practice Guidelines American Stroke Association American Association of Neuroscience Nurses American Association of Neurological Surgeons American College of Radiology American Society of Neuroradiology Congress of Neurological Surgeons Society of Atherosclerosis Imaging and Prevention Society for Cardiovascular Angiography and Interventions Society of Interventional Radiology Society of NeuroInterventional Surgery Society for Vascular Medicine Society for Vascular Surgery American Academy of Neurology and Society of Cardiovascular Computed Tomography 2011 ASA ACCF AHA AANN AANS ACR ASNR CNS SAIP SCAI SIR SNIS SVM SVS guideline on the management of patients with extracranial carotid and vertebral artery disease executive summary. Stroke 42 e , Chambers BR, Donnan GA Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev CD001923, Davis SM, Donnan GA Carotid artery stenting in stroke prevention. N Engl J Med , Executive Committee for the Asymptomatic Carotid Atherosclerosis Study Endarterectomy for asymptomatic carotid artery stenosis. JAMA , Gurm HS, Yadav JS, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Ansel G, Strickman NE, Wang H, Cohen SA, Massaro JM, Cutlip DE SAPPHIRE Investigators Long term results of carotid stenting versus endarterectomy in high risk patients. N Engl J Med , Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D MRC Asymptomatic Carotid Surgery Trial ACST Collaborative Group Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms randomised controlled trial. Lancet , EBM International Carotid Stenting Study investigators, Ederle J, Dobson J, Featherstone RL, Bonati LH, van der Worp HB, de Borst GJ, Lo TH, Gaines P, Dorman PJ, Macdonald S, Lyrer PA, Hendriks JM, McCollum C, Nederkoorn PJ, Brown MM Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis International Carotid Stenting Study an interim analysis of a randomised controlled trial. Lancet , Mackey AE, Abrahamowicz M, Langlois Y, Battista R, Simard D, Bourque F, Leclerc J, Côté R Outcome of asymptomatic patients with carotid disease. Asymptomatic Cervical Bruit Study Group. Neurology ,

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