特集閉塞性血管障害病変の課題と展望 Current Indications and Problems of CEA and CAS Hidenori Endo, M.D., Ph.D. 1, Miki Fujimura, M.D., Ph.D. 2, Yasushi Matsumoto, M.D.

Size: px

Start display at page:

Download "特集閉塞性血管障害病変の課題と展望 Current Indications and Problems of CEA and CAS Hidenori Endo, M.D., Ph.D. 1, Miki Fujimura, M.D., Ph.D. 2, Yasushi Matsumoto, M.D."

ありおきこいまる
4 years ago
Views:

1 特集閉塞性血管障害病変の課題と展望 Current Indications and Problems of CEA and CAS Hidenori Endo, M.D., Ph.D. 1, Miki Fujimura, M.D., Ph.D. 2, Yasushi Matsumoto, M.D. 3, Toshiki Endo, M.D., Ph.D. 2, Kenichi Sato, M.D., Ph.D. 3, Kuniyasu Niizuma, M.D., Ph.D. 1, Takashi Inoue, M.D., Ph.D. 4, and Teiji Tominaga, M.D., Ph.D. 1 Key words Jpn J Neurosurg Tokyo , 2018 はじめに carotid endarterectomy CEA carotid artery stenting CAS randomized controlled trial RCT CEA vs CAS CEA CAS RCT CEA CAS

2 Table 1 Randomized controlled trial for carotid endarterectomy Trial Journal Cases Objective Stenosis Period Primary endpoints Results BMT CEA P value Conclusions NASCET NEJM 1991, 2,885 Symptomatic 70 2 Y Ipsilateral stroke CEA BMT Y Y Non superiority of CEA ECST Lancet 1991, 3,024 Symptomatic 80 3 Y Stroke death CEA BMT 1998 ACAS JAMA ,662 Asymptomatic 60 5 Y Ipsilateral stroke CEA BMT perioperative stroke death ACST Lancet ,120 Asymptomatic 60 5 Y Any stroke CEA BMT RCT ramdomized controlled trial, BMT best medical treatment, CEA carotid endarterectomy CEA と CAS の適応 1 RCT 1 CEA RCT Table 1 CEA RCT CEA North American Symptomatic Carotid Endarterectomy Trial NASCET 2 3 European Carotid Surgery Trial ECST NASCET RCT transient ischemic attack TIA nondisabling stroke 120 CEA CEA 9 26 CEA CEA CEA 3 50 ECST RCT TIA CEA CEA NASCET ECST ECST 80 NASCET CEA NASCET 5.8 ECST 5.6 NASCET ECST CEA 25 CEA RCT Asymptomatic Carotid Atherosclerosis Study ACAS 9 Asymptomatic Carotid Surgery Trial ACST 12 ACAS RCT NASCET 60 CEA CEA 5.1 CEA CEA ACST 6 NASCET CEA 6.4 CEA CEA ACAS 75 ACAS 2.7 ACST CEA 2 CAS RCT Table 2 CAS CEA Jpn J Neurosurg VOL. 27 NO

3 Table 2 Randomized controlled trial for carotid artery stenting Trial SAPPHIRE EVA 3S SPACE ICSS CREST ACT I Journal NEJM 2004 NEJM 2006 Lancet 2006 Lancet 2010 NEJM 2010 NEJM 2016 Cases ,183 1,710 2,502 1,453 CAS 167 CEA CAS 261 CEA CAS 599 CEA CAS 853 CEA CAS 1,262 CEA CAS 1,089 CEA Objective CEA high risk Symptomatic Symptomatic Symptomatic Symptomatic Asymptomatic Symptomatic Asymptomatic Asymptomatic Protection device Must Angioguard XP Any at first EPD with 2 cases experience thereafter Stent Smart Precise Any Carotid Wallstent Precise Acculink Primary endopoints Death stroke Stroke death MI 30 days 30 days Death ipsilateral stroke 1 Y Results CAS 12.2 vs CEA 20.1 Conclusions Non inferiority of CAS CAS 9.6 vs CEA 3.9 Discontinuation for poor results of CAS Any Any RX Accunet must Ipsilateral stroke death 30 days CAS 6.84 vs CEA 6.34 Not prove non inferiority of CAS Any RX Acculink must Emboshield must Xact must Severe stroke Stroke MI Death Stroke MI Death 3 Ys 30 days Ipsilateral stroke 4 years 30 days Ipsilateral stroke 1 Y CAS 8.5 vs CEA 5.2 CAS 7.2 vs CEA 6.8 Inferiority of CAS CEA CAS CAS 3.8 vs CEA 3.4 Non inferiority of CAS RCT CAS RCT CEA CAS RCT 2004 Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy SAPPHIRE 31 SAPPHIRE CEA 334 CAS CEA CAS 12.2 CEA 20.1 CAS p CEA CEA CAS SAPPHIRE CEA 80 CEA CEA CAS CEA RCT Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis EVA 3S 17 Stent Protected Angioplasty versus Carotid Endarterectomy SPACE 28 International Carotid Stenting Study ICSS 14 CAS CEA CAS protection device Stenting versus Endarterectomy for Treatment of Carotid Artery Stenosis CREST CAS CEA ,502 CEA CAS CREST Interventional Management Committee embolic protection device EPD RX Accunet embolic protection device RX Acculink stent Abbott, Illinois

4 4 2.5 CEA 6.8 CAS 7.2 CAS 0.7 CEA 0.3 CAS p 0.18 CAS 4.1 CEA 2.3 CAS p 0.01 CAS 1.1 CEA 2.3 CEA p 0.03 CAS 2.0 CEA 2.4 CREST 10 CEA 9.9 CAS CEA CAS CEA CREST 70 CEA 7 Asymptomatic Carotid Trial ACT I 70 CEA CAS EPD Emboshield Abbott Xact Abbott 30 1 CAS 3.8 CEA 3.4 CAS 2 治療ガイドライン RCT 2015 CEA 22 SAPPHIRE CAS CEA 22 CREST 2011 American Heart Association AHA American Stroke Association ASA CAS CEA CEA CAS CEA 16 CEA CAS 18 ACST2 CEA CAS 26 CREST2 CEA CAS 13 RCT CEA と CAS の課題 1 危険因子 Second Manifestations of Arterial disease SMART study CEA NASCET ACAS CAS Japanese CAS survey CEA CAS CEA SAPPHIRE 31 Sundt 29 Fig. 1 Sundt 24 7 TIA CAS Fig fibrous cap intraplaque hemorrhage IPH lipid rich necrotic core 30 CAS Time of flight magnetic resonance angiography IPH 34 expansive Jpn J Neurosurg VOL. 27 NO

CEA CAS Cardiopulmonary disease Renal dysfunction Contralateral occlusion Allergy metal/contrast Contralateral

palsy Radiation Contraindication for anti thrombotic agent Previous surgery Aortic valve stenosis High or low

TIA Fig. 1 A Risk factors for CEA and CAS C B D E Fig.

spotty ischemic lesions in the left cerebral hemisphere.

calcified plaque. C Time of flight magnetic resonance angiography showing the plaque with high intensity signal.

5 CEA CAS Cardiopulmonary disease Renal dysfunction Contralateral occlusion Allergy metal/contrast Contralateral laryngeal n. palsy Radiation Contraindication for anti thrombotic agent Previous surgery Aortic valve stenosis High or low position Unsuitable access route Aged patient Calcification Recent cerebrovascular events Unstable plaque Crescendo TIA Fig. 1 A Risk factors for CEA and CAS C B D E Fig. 2 A 79 year old man with symptomatic left carotid artery stenosis A Diffusion weighted imaging showing the multiple spotty ischemic lesions in the left cerebral hemisphere. B Three dimensional computed tomography showing moderate stenosis NASCET 60 of the left carotid artery with partially calcified plaque. C Time of flight magnetic resonance angiography showing the plaque with high intensity signal. D Long axis black blood imaging of the plaque indicating the high rate of expansive remodeling. E Intraoperative photography showing intraplaque hemorrhage. arterial remodeling32 は CAS における虚血性合併症の危増加をきたし27 虚血性合併症につながる可能性があ険因子として注目されている15 CAS のみならず CEA り注意を要する他にもさまざまなプラーク診断方法においても不安定プラークは術中 microembolic signal のが報告されており術前プラーク診断は手術リスクを見 518 脳外誌 27 巻 7 号 2018 年 7 月

Fig. 2 CAS plaque prolapse Fig. 3 21 CLEAR ROAD study CEA 30 2.

3 The design of CASPER TM carotid stent Terumo, Tokyo, which is a novel self expanding stent with a dual layer tubular nitinol mesh, designed to provide sustained embolic protection by extensive

6 Fig. 2 CAS plaque prolapse Fig CLEAR ROAD study CEA 将来展望 CEA CAS CREST 70 CAS CEA CREST CAS 23 CAS CAS learning curve CAS CEA CEA surgeon CEA surgeon 結語 CEA CAS RCT CAS CEA surgeon Fig. 3 The design of CASPER TM carotid stent Terumo, Tokyo, which is a novel self expanding stent with a dual layer tubular nitinol mesh, designed to provide sustained embolic protection by extensive plaque coverage and prevention of plaque prolapse. COI COI 文献 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 e , American Symptomatic Carotid Endarterectomy Trial Collaborators, Barnett HJM, Taylor DW, Haynes RB, Sackett DL, Peerless SJ, Ferguson GG, Fox AJ, Rankin RN, Hachinski VC, Wiebers DO, Eliasziw M Beneficial effect of carotid endarterectomy in symptomatic patients with high grade carotid stenosis. N Engl J Med , 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 Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med , Bosiers M, Deloose K, Torsello G, Scheinert D, Maene L, Peeters P, Müller Hülsbeck S, Sievert H, Langhoff R, Bosiers M, Setacci C The CLEAR ROAD study evaluation of a new dual layer micromesh stent system for the carotid artery. EuroIntervention 12 e , Brott TG, Hobson RW 2nd, Howard G, Roubin GS, Clark WM, Brooks W, Mackey A, Hill MD, Leimgruber PP, Sheffet Jpn J Neurosurg VOL. 27 NO

7 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 , Brott TG, Howard G, Roubin GS, Meschia JF, Mackey A, Brooks W, Moore WS, Hill MD, Mantese VA, Clark WM, Timaran CH, Heck D, Leimgruber PP, Sheffet AJ, Howard VJ, Chaturvedi S, Lal BK, Voeks JH, Hobson RW 2nd CREST Investigators Long Term Results of Stenting versus Endarterectomy for Carotid Artery Stenosis. N Engl J Med , den Hartog AG, Achterberg S, Moll FL, Kappelle LJ, Visseren FL, van der Graaf Y, Algra A, de Borst GJ SMART Study Group Asymptomatic carotid artery stenosis and the risk of ischemic stroke according to subtype in patients with clinical manifest arterial disease. Stroke , Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA , Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, Halperin JL, Johnston SC, Katzan I, Kernan WN, Mitchell PH, Ovbiagele B, Palesch YY, Sacco RL, Schwamm LH, Wassertheil Smoller S, Turan TN, Wentworth D American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Interdisciplinary Council on Quality of Care and Outcomes Research Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack a guideline for healthcare professionals from the American Heart Association American Stroke Association. Stroke , Goldstein LB, Bushnell CD, Adams RJ, Appel LJ, Braun LT, Chaturvedi S, Creager MA, Culebras A, Eckel RH, Hart RG, Hinchey JA, Howard VJ, Jauch EC, Levine SR, Meschia JF, Moore WS, Nixon JV, Pearson TA American Heart Association Stroke Council Council on Cardiovascular Nursing Council on Epidemiology and Prevention Council for High Blood Pressure Research, Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research Guidelines for the primary prevention of stroke a guideline for healthcare professionals from the American Heart Association American Stroke Association. Stroke , 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 , Howard VJ, Meschia JF, Lal BK, Turan TN, Roubin GS, Brown RD Jr, Voeks JH, Barrett KM, Demaerschalk BM, Huston J 3rd, Lazar RM, Moore WS, Wadley VG, Chaturvedi S, Moy CS, Chimowitz M, Howard G, Brott TG CREST 2 study investigators Carotid revascularization and medical management for asymptomatic carotid stenosis Protocol of the CREST 2 clinical trials. Int J Stroke , 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 , Kashiwazaki D, Kuwayama N, Akioka N, Noguchi K, Kuroda S Carotid plaque with expansive arterial remodeling is a risk factor for ischemic complication following carotid artery stenting. Acta Neurochir Wien , Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack a guideline for healthcare professionals from the American Heart Association American Stroke Association. Stroke , Mas JL, Trinquart L, Leys D, Albucher JF, Rousseau H, Viguier A, Bossavy JP, Denis B, Piquet P, Garnier P, Viader F, Touzé E, Julia P, Giroud M, Krause D, Hosseini H, Becquemin JP, Hinzelin G, Houdart E, Hénon H, Neau JP, Bracard S, Onnient Y, Padovani R, Chatellier G EVA 3S investigators Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis EVA 3S trial results up to 4 years from a randomised, multicentre trial. Lancet Neurol , Meschia JF, Bushnell C, Boden Albala B, Braun LT, Bravata DM, Chaturvedi S, Creager MA, Eckel RH, Elkind MS, Fornage M, Goldstein LB, Greenberg SM, Horvath SE, Iadecola C, Jauch EC, Moore WS, Wilson JA American Heart Association Stroke Council Council on Cardiovascular and Stroke Nursing Council on Clinical Cardiology Council on Functional Genomics and Translational Biology Council on Hypertension Guidelines for the primary prevention of stroke a statement for healthcare professionals from the American Heart Association American Stroke Association. Stroke ,

8 19 Miyachi S, Taki W, Sakai N, Nakahara I Japanese CAS Survey Investigators Historical perspective of carotid artery stenting in Japan analysis of 8,092 cases in The Japanese CAS survey. Acta Neurochir Wien , MRC European Carotid Surgery Trial interim results for symptomatic patients with severe or with mild 0 29 carotid stenosis. European Carotid Surgery Trialists Collaborative Group. Lancet , Nerla R, Castriota F, Micari A, Sbarzaglia P, Secco GG, Ruffino MA, de Donato G, Setacci C, Cremonesi A Carotid artery stenting with a new generation double mesh stent in three high volume Italian centres clinical results of a multidisciplinary approach. EuroIntervention 12 e , Otite FO, Khandelwal P, Malik AM, Chaturvedi S National Patterns of Carotid Revascularization Before and After the Carotid Revascularization Endarterectomy vs Stenting Trial CREST. JAMA Neurol , Randomised trial of endarterectomy for recently symptomatic carotid stenosis final results of the MRC European Carotid Surgery Trial ECST. Lancet , Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ Carotid Endarterectomy Trialists Collaboration Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet , Rudarakanchana N, Dialynas M, Halliday A Asymptomatic Carotid Surgery Trial 2 ACST 2 rationale for a randomised clinical trial comparing carotid endarterectomy with carotid artery stenting in patients with asymptomatic carotid artery stenosis. Eur J Vasc Endovasc Surg , Sato Y, Ogasawara K, Narumi S, Sasaki M, Saito A, Tsushima E, Namba T, Kobayashi M, Yoshida K, Terayama Y, Ogawa A Optimal MR Plaque Imaging for Cervical Carotid Artery Stenosis in Predicting the Development of Microembolic Signals during Exposure of Carotid Arteries in Endarterectomy Comparison of 4 T1 Weighted Imaging Techniques. AJNR Am J Neuroradiol , SPACE Collaborative Group, Ringleb PA, Allenberg J, Brückmann H, Eckstein HH, Fraedrich G, Hartmann M, Hennerici M, Jansen O, Klein G, Kunze A, Marx P, Niederkorn K, Schmiedt W, Solymosi L, Stingele R, Zeumer H, Hacke W 30 day results from the SPACE trial of stent protected angioplasty versus carotid endarterectomy in symptomatic patients a randomised non inferiority trial. Lancet , Sundt TM Jr, Whisnant JP, Houser OW, Fode NC Prospective study of the effectiveness and durability of carotid endarterectomy. Mayo Clin Proc , Takaya N, Yuan C, Chu B, Saam T, Underhill H, Cai J, Tran N, Polissar NL, Isaac C, Ferguson MS, Garden GA, Cramer SC, Maravilla KR, Hashimoto B, Hatsukami TS Association between carotid plaque characteristics and subsequent ischemic cerebrovascular events a prospective assessment with MRI initial results. Stroke , Yadav JS, Wholey MH, Kuntz RE, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Whitlow P, Strickman NE, Jaff MR, Popma JJ, Snead DB, Cutlip DE, Firth BG, Ouriel K Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators Protected carotid artery stenting versus endarterectomy in high risk patients. N Engl J Med , Yoshida K, Fukumitsu R, Kurosaki Y, Funaki T, Kikuchi T, Takahashi JC, Takagi Y, Yamagata S, Miyamoto S The association between expansive arterial remodeling detected by high resolution MRI in carotid artery stenosis and clinical presentation. J Neurosurg , JNET 3 Suppl Yoshimura S, Yamada K, Kawasaki M, Asano T, Kanematsu M, Takamatsu M, Hara A, Iwama T High intensity signal on time of flight magnetic resonance angiography indicates carotid plaques at high risk for cerebral embolism during stenting. Stroke , 要旨 CEA CAS RCT CEA RCT CEA CAS RCT CEA CAS 脳外誌 27: ,2018 Jpn J Neurosurg VOL. 27 NO

JCAS 対象および方法 prospective registry CEA CAS JCAS RCT 2 JCAS TIA minor stroke major stroke mrs CEA CAS 1 3 SPECT case volume CEA CAS 結果

JCAS 対象および方法 prospective registry CEA CAS JCAS RCT 2 JCAS TIA minor stroke major stroke mrs CEA CAS 1 3 SPECT case volume CEA CAS 結果 Online publication January 14, 2011 原著第 50 回総会シンポジウム 5 日本脳神経血管内治療学会 : 頭頸部頭蓋内血管に対する血行再建術本邦における頸動脈治療の前向き登録 (JCAS 研究 ) 1 1 JCAS 要旨 :JCAS 5053 1164 69.8 87 45 CAE 34 CAS 2130 major adverse events CEA 3.2

特集 閉塞性血管障害病変の課題と展望 Current Indications and Problems of CEA and CAS Hidenori Endo, M.D., Ph.D. 1, Miki Fujimura, M.D., Ph.D. 2, Yasushi Matsumoto, M.D.

特集閉塞性血管障害病変の課題と展望 Current Indications and Problems of CEA and CAS Hidenori Endo, M.D., Ph.D. 1, Miki Fujimura, M.D., Ph.D. 2, Yasushi Matsumoto, M.D.