Basic Data Underlying Clinical Decision-Making in Endovascular Therapy Editor, Timothy M. Sullivan

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1 Basic Data Underlying Clinical Decision-Making in Endovascular Therapy Editor, Timothy M. Sullivan Carotid Artery Stenting David Paul Slovut, Sioux Falls, South Dakota ACRONYMS ALKK, Arbeitsgemeinschaft Leitende Kardiologische Krankenhaus artze Carotid Artery Stent Registry; ARCHeR, ACCULINK for Revascularization of Carotids in High-Risk patients; ARMOUR, Proximal Protection with the MO.MA Device during Carotid Stenting; BEACH, Boston Scientific EPI: A Carotid Stenting Trial for High-Risk Surgical Patients; CABERNET, Carotid Artery Revascularization Using the Boston Scientific FilterWire; EXÒ/ EZÔ and the EndotexÔ NexStentÒ; CARESS, Carotid Revascularization using Endarterectomy or Stenting Systems; CAS, Carotid Artery Stenting; CASES-PMS, CAS with Emboli Protection SurveillancedPost Marketing Study; CAST I, Carotid Artery Stent Trial; CAVATAS, Carotid and Vertebral Transluminal Angioplasty Study; CEA, Carotid Endarterectomy; CREATE, Carotid Revascularization with ev3 Arterial Technology Evolution; CREST, Carotid Revascularization Endarterectomy vs. Stenting Trial; EPD, Embolic Protection Device; EVA-3S, Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis; ICSS, International Carotid Stenting Study (CAVA- TAS-2); MAVErIC, Evaluation of the Medtronic AVE Self-Expanding Carotid Stent System with Department of Vascular Medicine, Heart Hospital of South Dakota, Sioux Falls, SD. Correspondence to: David Paul Slovut, MD, PhD, Heart Hospital of South Dakota, 4500 West 69th Street, Sioux Falls, SD 57108, david.slovut@mssm.edu Ann Vasc Surg 2011; 25: DOI: /j.avsg Ó Annals of Vascular Surgery Inc. Distal Protection in the Treatment of Carotid Stenosis; NR, not reported; PRIAMUS, Proximal flow blockage cerebral protection during carotid stenting; Pro-CAS, Prospective Registry of Carotid Artery Stenting; PTA, percutaneous transluminal angioplasty; SAPPHIRE, Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy; SECuRITY, Study to Evaluate the Neuroshield Bare Wire Cerebral Protection System and X-Act Stent in Patients at High Risk for Carotid Endarterectomy; SPACE, Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy; TLR, target lesion revascularization. REFERENCES 1. Naylor AR, Bolia A, Abbott RJ, et al. Randomized study of carotid angioplasty and stenting versus carotid endarterectomy: a stopped trial. J Vasc Surg 1998;28: Henry M, Amor M, Masson I, et al. Angioplasty and stenting of the extracranial carotid arteries. J Endovasc Surg 1998;5: Chastain HD 2nd, Gomez CR, Iyer S, et al. Influence of age upon complications of carotid artery stenting. UAB Neurovascular Angioplasty Team. J Endovasc Surg 1999;6: Bergeron P, Becquemin JP, Jausseran JM, et al. Percutaneous stenting of the internal carotid artery: the European CAST I Study. Carotid Artery Stent Trial. J Endovasc Surg 1999;6: Alberts MJ. Results of a multicenter prospective registry randomized trial of carotid artery stenting vs. carotid endarterectomy. Stroke 2001;32:325d. 6. Roubin GS, New G, Iyer SS, et al. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation 2001;103:

2 288 Carotid artery stenting Annals of Vascular Surgery 7. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Lancet 2001;357: Brooks WH, McClure RR, Jones MR, Coleman TC, Breathitt L. Carotid angioplasty and stenting versus carotid endarterectomy: randomized trial in a community hospital. J Am Coll Cardiol 2001;38: Bonaldi G. Angioplasty and stenting of the cervical carotid bifurcation: report of a 4-year series. Neuroradiology 2002;44: 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: discussion Bibl D, Lampl C, Biberhofer I, et al. Internal carotid artery stent placement without emboli protection: results and long-term outcome. Neurology 2005;65: Ringleb PA, Allenberg J, Bruckmann H, 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: Al-Mubarak N, Colombo A, Gaines PA, et al. Multicenter evaluation of carotid artery stenting with a filter protection system. J Am Coll Cardiol 2002;39: Henry M, Henry I, Klonaris C, et al. Benefits of cerebral protection during carotid stenting with the PercuSurge GuardWire system: midterm results. J Endovasc Ther 2002;9: Cremonesi A, Manetti R, Setacci F, Setacci C, Castriota F. Protected carotid stenting: clinical advantages and complications of embolic protection devices in 442 consecutive patients. Stroke 2003;34: Carotid revascularization using endarterectomy or stenting systems (CARESS): phase I clinical trial. J Endovasc Ther 2003;10: Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotidartery stenting versus endarterectomy in high-risk patients. N Engl J Med 2004;351: Hobson RW 2nd, Howard VJ, Roubin GS, et al. Carotid artery stenting is associated with increased complications in octogenarians: 30-day stroke and death rates in the CREST lead-in phase. J Vasc Surg 2004;40: Zahn R, Roth E, Ischinger T, et al. Carotid artery stenting in clinical practice results from the Carotid Artery Stenting (CAS)-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK). Z Kardiol 2005;94: Cremonesi A. The SPIDER Embolic Protection Device performance evaluation in the carotid artery during percutaneous transluminal angioplasty and or stenting. J Invasive Cardiol 2005;17: Coppi G, Moratto R, Silingardi R, et al. PRIAMUSdproximal flow blockage cerebral protection during carotid stenting: results from a multicenter Italian registry. J Cardiovasc Surg (Torino) 2005;46: Xact Carotid Stent System. Summary of Safety and Effectiveness Data P September 6, Available at: Procedures/DeviceApprovalsandClearances/Recently-Approved Devices/ucm htm. 23. Gray WA, Hopkins LN, Yadav S, et al. Protected carotid stenting in high-surgical-risk patients: the ARCHeR results. J Vasc Surg 2006;44: White CJ, Iyer SS, Hopkins LN, Katzen BT, Russell ME. Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results. Catheter Cardiovasc Interv 2006;67: Safian RD, Bresnahan JF, Jaff MR, et al. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol 2006;47: Mas JL, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355: Hill MD, Morrish W, Soulez G, et al. Multicenter evaluation of a self-expanding carotid stent system with distal protection in the treatment of carotid stenosis. Am J Neuroradiol 2006;27: Setacci C, Chisci E, de Donato G, Setacci F, Sirignano P, Galzerano G. Carotid artery stenting in a single center: are six years of experience enough to achieve the standard of care? Eur J Vasc Endovasc Surg 2007;34: Katzen BT, Criado FJ, Ramee SR, et al. Carotid artery stenting with emboli protection surveillance study: thirty-day results of the CASES-PMS study. Catheter Cardiovasc Interv 2007;70: Gray WA, Yadav JS, Verta P, et al. The CAPTURE registry: predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval setting. Catheter Cardiovasc Interv 2007;70: Hopkins LN, Myla S, Grube E, et al. Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial. Catheter Cardiovasc Interv 2008;71: Kastrup A, Groschel K, Nagele T, et al. Effects of age and symptom status on silent ischemic lesions after carotid stenting with and without the use of distal filter devices. Am J Neuroradiol 2008;29: Theiss W, Hermanek P, Mathias K, et al. Predictors of death and stroke after carotid angioplasty and stenting: a subgroup analysis of the Pro-CAS data. Stroke 2008;39: Sidawy AN, Zwolak RM, White RA, Siami FS, Schermerhorn ML, Sicard GA. Risk-adjusted 30-day outcomes of carotid stenting and endarterectomy: results from the SVS Vascular Registry. J Vasc Surg 2009;49: Micari A, Stabile E, Cremonesi A, et al. Carotid artery stenting in octogenarians using a proximal endovascular occlusion cerebral protection device: a multicenter registry. Catheter Cardiovasc Interv 2010;76: Ansel GM, Hopkins LN, Jaff MR, et al. Safety and effectiveness of the INVATEC MO.MA proximal cerebral protection device during carotid artery stenting: results from the ARMOUR pivotal trial. Catheter Cardiovasc Interv 2010;76: Ederle J, Dobson J, Featherstone RL, et al. 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 2010;375: Luebke T, Aleksic M, Brunkwall J. Meta-analysis of randomized trials comparing carotid endarterectomy and endovascular treatment. Eur J Vasc Endovasc Surg 2007;34: Giacovelli JK, Egorova N, Dayal R, Gelijns A, McKinsey J, Kent KC. Outcomes of carotid stenting compared with endarterectomy are equivalent in asymptomatic patients and inferior in symptomatic patients. J Vasc Surg 2010;52: , 913.e1-e4.

3 Vol. 25, No. 2, February 2011 Carotid artery stenting Kastrup A, Schulz JB, Raygrotzki S, Groschel K, Ernemann U. Comparison of angioplasty and stenting with cerebral protection versus endarterectomy for treatment of internal carotid artery stenosis in elderly patients. J Vasc Surg 2004;40: Longo GM, Kibbe MR, Eskandari MK. Carotid artery stenting in octogenarians: is it too risky? Ann Vasc Surg 2005;19: Zahn R, Ischinger T, Hochadel M, et al. Carotid artery stenting in octogenarians: results from the ALKK Carotid Artery Stent (CAS) Registry. Eur Heart J 2007;28: Stingele R, Berger J, Alfke K, 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: Bacharach JM, Slovut DP, Ricotta J, Sullivan TM. Octogenarians are not at increased risk for periprocedural stroke following carotid artery stenting. Ann Vasc Surg 2010;24: Henry M, Henry I, Klonaris C, Masson I, Hugel M, Tzvetanov K, Ethevenot G, Le BE, Kownator S, Luizi F, Folliguet B. Benefits of cerebral protection during carotid stenting with the PercuSurge GuardWire system: midterm results. J Endovasc Ther 2002;9: Gurm HS, Yadav JS, Fayad P, et al. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med 2008;358: Eckstein HH, Ringleb P, Allenberg JR, et al. Results of the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial. Lancet Neurol 2008;7: Iyer SS, White CJ, Hopkins LN, et al. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J Am Coll Cardiol 2008;51: de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A, Bosiers M. Long-term results of carotid artery stenting. J Vasc Surg 2008;48: discussion Schreiber TL, Strickman N, Davis T, et al. Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year. J Am Coll Cardiol 2010;56: Higashida RT, Popma JJ, Apruzzese P, Zimetbaum P. Evaluation of the medtronic exponent self-expanding carotid stent system with the medtronic guardwire temporary occlusion and aspiration system in the treatment of carotid stenosis: combined from the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection In the treatment of Carotid stenosis) I and MAVErIC II trials. Stroke 2010;41:e102-e Hopkins LN, Myla SV, Grube E, et al. Carotid artery revascularisation in high-surgical-risk patients with the NexStent and the FilterWire EX/EZ: 3-year results from the CABER- NET trial. EuroIntervention 2010;5: Brott TG, Hobson RW 2nd, Howard G, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med 2010;363: Table I. Periprocedural outcomes within 30 days of CAS without EPD MI/CVA/death Comment Symptoms (%) MI Stroke Death Trial/author Year n Type Leicester/Naylor et al RCT 100 NR 71.4 NR NR Trial suspended for 71.4% CVA rate Henry et al Registry EPD using balloon occlusion in 32 patients Chastain et al Registry Neurologic complications, 25% for age >80 vs. 8.6% for age <75 CAST I/Bergeron et al Registry 42 NR % of stents placed via direct cervical approach Wallstent/Alberts RCT 100 NR NR NR 12.1 Study terminated for futility. Published only as abstract Roubin et al Registry year freedom from nonfatal and fatal CVA 88% CAVATAS RCT PTA in 74%, PTA with bailout stenting in 26% Kentucky/Brooks et al RCT CAS equivalent to CEA Bonaldi Registry 100 NR Single center. No EPD in 80% of patients Kentucky II/Brooks et al RCT 0 NR Single-center community hospital Bibl et al Registry 44 NR SPACE RCT 90 NR EPS in 27%. Failed to prove noninferiority of CAS with CEA based on rate of ipsilateral CVA or death within 30 days. MI, myocardial infarction; CVA, cerebral vascular accident; RCT, randomized control trial.

4 Table II. Periprocedural outcomes within 30 days of CAS with EPD Trial/author Year n Type Symptoms (%) MI Stroke Death MI/CVA/death Comment Al-Mubarak et al Registry Henry et al Registry 49 NR Balloon occlusion for EPD (PercuSurge GuardWire system) Cremonesi et al Registry 57 NR CVA includes four patients with intracranial hemorrhage CARESS RCT Carotid stenting with EPD equivalent to standard CEA SAPPHIRE/Yadav et al. 17,a RCT CAS noninferior to CEA CREST/Hobson et al Registry 31 NR No EPD in 11.9% of patients treated early in series ALKK/Zahn et al ,840 Registry Hospital event rate (not 30-day). Contralateral ischemic events in 1.4%. % patients with EPD not reported Cremonesi Registry PRIAMUS/Coppi et al Registry Proximal occlusion EPD (MO.MA device) SECuRITY Registry Results never published in peer-reviewed journal ARCHeR/Gray et al Registry BEACH/White et al Registry CREATE/Safian et al Registry Predictors of CVA/death: symptomatic carotid stenosis (OR, 2.9), renal insufficiency (OR, 2.9), filter deployment time EVA-3S/Mas et al RCT Trial stopped for safety and futility. Relative risk of CVA or death 2.5 greater for stent than CEA MAVErIC/Hill et al Registry NR Setacci et al ,035 Registry Single-center, retrospective review CASES-PMS/Katzen et al ,493 Registry CAPTURE/Gray et al ,500 Registry Predictors of 30-day mortality: symptoms, age, use of multiple stents, predilation before EPD CABERNET/Hopkins et al Registry Kastrup et al Registry 55 NR EPD in 72%. Use of EPD reduced rate of new diffusion-weighted imaging lesions on MRI Pro-CAS/Theiss et al ,341 Registry 55 NR Hospital event rate (not 30-day). No EPD in 24.8% of patients. Sidawy et al ,450 Registry endpoint for CEA 2.6% ( p < 0.001). CAS group had higher proportion of symptomatic patients (49.2% vs. 42.4%, p < 0.001) Micari et al Registry 39 NR MO.MA device. Proximal occlusion intolerance in 8.1% ARMOUR/Ansel et al Registry Roll-in + intention-to-treat population ICSS/Ederle et al RCT EPD in 72% A meta-analysis of eight RCTs 1,5,7,8,10,12,17,26 included 1,480 patients randomized to CEA and 1,492 randomized to CAS. 38 Results favored CEA over CAS for death or any CVA at 30 days (OR, 1.39), ipsilateral ischemic stroke at 30 days (OR, 1.48), any CVA at 30 days (OR, 1.5), and risk of procedural failure (OR, 3.42). There was no difference in the odds of death or CVA at 1 year after the procedure (OR, 1.01). Five of the trials did not utilize EPD, a sixth 12 used EPS in 27% of patients. a SAPPHIRE eligibility criteria required at least one high-risk factor: clinically significant cardiac disease, severe pulmonarydisease, contralateral carotid occlusion, contralateral laryngeal nerve palsy, previous radical neck surgery or radiation therapy to the neck, recurrent stenosis after CEA, or age > Carotid artery stenting Annals of Vascular Surgery

5 Table III. Peri-procedural outcomes within 30 days of CAS with EPD for asymptomatic and symptomatic patients Trial/author Year No symptoms n MI Stroke Death Symptoms MI/CVA/death n MI Stroke Death MI/CVA/death Comment Cremonesi et al NR NR Bibl et al NR NR No EPD ALKK/Zahn et al NR NR NR NR 4.7 p ¼ Hospital event rate (not 30-day) ARCHeR/Gray et al p for composite endpoint not reported BEACH/White et al Stroke rate p ¼ p for composite endpoint not significant CAPTURE/Gray et al , p < 0.05 for composite endpoint CASES-PMS/Katzen et al , CABERNET/Hopkins et al Major stroke, p ¼ 0.03 Kastrup et al NR NR Pro-CAS/Theiss et al ,412 NR NR NR 2.7 2,921 NR NR NR 4.3 p ¼ Sidawy et al p ¼ for stroke; p ¼ 0.4 for composite endpoint Micari et al NR NR ICSS/Ederle et al Giacovelli et al ,353 NR NR CAS (8.3%) inferior to CEA (4.6%) for the combined endpoint of stroke and mortality. Use of EPD not reported All studies in this table are registries except: 1. ICSS, which is an RCT. 2. Giacovelli et al., which is an analysis of in-hospital mortality and postoperative stroke in 47,752 CAS or CEA hospitalizations, matched by propensity score, in discharge data obtained from New York and California from Vol. 25, No. 2, February 2011 Carotid artery stenting 291

6 Table IV. Peri-procedural outcomes within 30 days of CAS with EPD in patients <75 and 75 years of age Author Year n/n <75/75 Type MI <75 Stroke Death MI/CVA/death MI 75 Stroke Death CREST 18,a /99 RCT NR NR Kastrup et al /53 Registry NR NR NR NR Longo et al. 41,a /29 Registry ALKK, Zahn et al. 42,b ,557/321 Registry Kastrup et al /37 Registry NR NR SPACE, Stingele et al /138 RCT NR NR NR 5.7 NR NR NR 10.9 Bacharach et al. 44,a /78 Registry Micari et al. 35,a /198 Registry NR ARMOUR, Ansel et al. 36,a /65 Registry NR 1.9 NR 2.6 NR 3.1 NR 3.1 a Age cut-off is <80 versus 80. b Complications during in-hospital phase (not 30-day). MI/CVA/death 292 Carotid artery stenting Annals of Vascular Surgery

7 Table V. Long-term outcomes after CAS in patients with EPD Author Year n Type Mean follow-up (years) MI Stroke Death MI/CVA/ death Comment CAVATAS RCT 1.9 NR NR NR 14.3 PTA in 74%, PTA with bailout stenting in 26% Henry et al Registry Event-free survival 97% at 20 months SAPPHIRE/Yadav et al RCT CAS noninferior to CEA ARCHeR/Gray et al Registry 1 NR 1.3 NR NR Ipsilateral stroke. Clinically driven TLR at 12 months 2.2% MAVErIC/Hill et al Registry Setacci et al Registry 3 NR NR NR 7.4 Single-center, retrospective review SPACE RCT 2 NR endpoint ipsilateral ischemic CVA or vascular death BEACH/Iyer at al Registry BEACH pivotal group. 1-year restenosis rate (70% by duplex ultrasound) 8.9%; 1-year TLR 4.7% SAPPHIRE/Gurm et al RCT Long-term outcome after CAS and CEA similar CABERNET/Hopkins et al Registry ¼ 30-day death, stroke, MI day ipsilateral stroke De Donato et al ,179 Registry 2.6 NR NR 5-year outcomes. Death is all-cause mortality CASES-PMS/Schreiber et al ,492 Registry No significant difference in outcome by symptom status or high-risk status MAVErIC I and II/Higashida et al Registry N ¼ 498 for intention-to-treat. TLR at 12 months 1.5% ICSS/Ederle et al RCT CAS patients had a 3.3% higher absolute risk of myocardial infarction, stroke, and death in the intention-to-treat analysis CABERNET, Hopkins et al Registry NR Asymptomatic patients had fewer major strokes than symptomatic patients and patients aged <80 years had fewer ipsilateral strokes than octogenarians CREST, Brott et al ,262 RCT 2.5 (median) NR CAS and CEA associated with similar primary outcomesdperiprocedural stroke, MI, or death and subsequent ipsilateral strokedamong both symptomatic and asymptomatic patients Vol. 25, No. 2, February 2011 Carotid artery stenting 293