Basic Data Underlying Clinical Decision-Making inEndovascular Therapy

Editor, Timothy M. Sullivan

DepartmenSioux Falls, SD

CorrespondSouth Dakota,david.slovut@m

Ann Vasc SurgDOI: 10.1016/� Annals of V

Carotid Artery Stenting

David Paul Slovut, Sioux Falls, South Dakota

ACRONYMS Distal Protection in the Treatment of Carotid

ALKK, Arbeitsgemeinschaft Leitende Kardiologi-

sche Krankenhaus€artze Carotid Artery Stent

Registry; ARCHeR, ACCULINK for Revasculariza-

tion of Carotids in High-Risk patients; ARMOUR,

Proximal Protectionwith theMO.MADevice during

Carotid Stenting; BEACH, Boston Scientific EPI: A

Carotid Stenting Trial for High-Risk Surgical

Patients; CABERNET, Carotid Artery Revasculariza-

tion Using the Boston Scientific FilterWire; EX�/

EZ� and the Endotex� NexStent�; CARESS,

Carotid Revascularization using Endarterectomy or

Stenting Systems; CAS, Carotid Artery Stenting;

CASES-PMS, CAS with Emboli Protection Surveil-

lancedPost Marketing Study; CAST I, Carotid

Artery Stent Trial; CAVATAS, Carotid and Vertebral

Transluminal Angioplasty Study; CEA, Carotid

Endarterectomy; CREATE, Carotid Revasculariza-

tion 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

t of Vascular Medicine, Heart Hospital of South Dakota,.

ence to: David Paul Slovut, MD, PhD, Heart Hospital of4500 West 69th Street, Sioux Falls, SD 57108, E-mail:ssm.edu

2011; 25: 287-293j.avsg.2010.12.001ascular Surgery Inc.

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 Endar-

terectomy; SECuRITY, Study to Evaluate the Neuro-

shield Bare Wire Cerebral Protection System and

X-Act Stent in Patients at High Risk for Carotid

Endarterectomy; SPACE, Stent-Supported Percuta-

neous Angioplasty of the Carotid Artery versus

Endarterectomy; TLR, target lesion revascularization.

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27. Hill MD, Morrish W, Soulez G, et al. Multicenter evaluation

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28. Setacci C, Chisci E, de Donato G, Setacci F, Sirignano P,

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29. Katzen BT, Criado FJ, Ramee SR, et al. Carotid artery stent-

ing with emboli protection surveillance study: thirty-day

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2007;70:316-323.

30. Gray WA, Yadav JS, Verta P, et al. The CAPTURE registry:

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embolic protection for high surgical risk patients in the early

post-approval setting. Catheter Cardiovasc Interv 2007;70:

1025-1033.

31. Hopkins LN, Myla S, Grube E, et al. Carotid artery revascu-

larization in high surgical risk patients with the NexStent

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32. Kastrup A, Groschel K, Nagele T, et al. Effects of age and

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33. Theiss W, Hermanek P, Mathias K, et al. Predictors of death

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2325-2330.

34. Sidawy AN, Zwolak RM, White RA, Siami FS,

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36. Ansel GM, Hopkins LN, Jaff MR, et al. Safety and effectiveness

of the INVATEC MO.MA proximal cerebral protection device

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37. Ederle J, Dobson J, Featherstone RL, et al. Carotid artery

stenting compared with endarterectomy in patients with

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Study): an interim analysis of a randomised controlled trial.

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470-479.

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906-913, 913.e1-e4.

eduraloutcomeswithin

30daysofCASwithoutEPD

Year

nType

Symptoms

(%)

MI

Stroke

Death

Composite

MI/CVA/death

Comment

al.1

1998

7RCT

100

NR

71.4

NR

NR

Trialsuspendedfor71.4%

CVA

rate

1998

163

Registry

35

03.1

03.1

EPD

usingballoonocclusionin

32patients

1999

182

Registry

62

0.5

9.3

0.5

10.4

Neurologic

complications,

25%

for

age>80vs.

8.6%

forage<75

tal.4

1999

99

Registry

42

NR

1.0

01.0

97%

ofstents

placedvia

direct

cervicalapproach

2001

107

RCT

100

NR

NR

NR

12.1

Studyterm

inatedforfutility.Publishedonly

asabstract

2001

528

Registry

52

0.2

7.2

1.7

8.1

3-yearfreedom

from

nonfatalandfatalCVA

88%

2001

251

RCT

90

08.0

3.0

10.0

PTA

in74%

,PTA

withbailoutstentingin

26%

tal.8

2001

53

RCT

100

00

00

CASequivalentto

CEA

2002

68

Registry

100

NR

5.6

05.6

Single

center.

NoEPD

in80%

ofpatients

setal.10

2004

43

RCT

0NR

00

0Single-centercommunityhospital

2005

302

Registry

44

NR

3.0

1.0

3.7

2006

599

RCT

90

NR

7.5

0.67

7.7

EPSin

27%

.Failedto

provenoninferiority

ofCAS

withCEA

basedonrate

ofipsilateralCVA

ordeath

within

30days.

tion;CVA,cerebralvascularaccident;RCT,randomizedcontroltrial.

Vol. 25, No. 2, February 2011 Carotid artery stenting 289

40. 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;40:945-951.

41. Longo GM, Kibbe MR, Eskandari MK. Carotid artery stent-

ing in octogenarians: is it too risky? Ann Vasc Surg

2005;19:812-816.

42. Zahn R, Ischinger T, Hochadel M, et al. Carotid artery stent-

ing in octogenarians: results from the ALKK Carotid Artery

Stent (CAS) Registry. Eur Heart J 2007;28:370-375.

43. 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 subanaly-

sis of the SPACE study. Lancet Neurol 2008;7:216-222.

44. Bacharach JM, Slovut DP, Ricotta J, Sullivan TM. Octoge-

narians are not at increased risk for periprocedural stroke

following carotid artery stenting. Ann Vasc Surg 2010;24:

153-159.

45. 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;9:1-13.

46. 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;358:1572-1579.

47. 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;7:893-902.

48. Iyer SS, White CJ, Hopkins LN, et al. Carotid artery revascu-

larization 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:

427-434.

49. de Donato G, Setacci C, Deloose K, Peeters P, Cremonesi A,

Bosiers M. Long-term results of carotid artery stenting.

J Vasc Surg 2008;48:1431-1440. discussion 40-41.

50. 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;56:49-57.

51. Higashida RT, Popma JJ, Apruzzese P, Zimetbaum P. Evalu-

ation 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-e109.

52. Hopkins LN, Myla SV, Grube E, et al. Carotid artery revascu-

larisation in high-surgical-risk patients with the NexStent

and the FilterWire EX/EZ: 3-year results from the CABER-

NET trial. EuroIntervention 2010;5:917-924.

53. Brott TG, Hobson RW 2nd, Howard G, et al. Stenting versus

endarterectomy for treatment of carotid-artery stenosis. N

Engl J Med 2010;363:11-23.

Table

I.Periproc

Trial/author

Leicester/Nayloret

Henry

etal.2

Chastain

etal.3

CASTI/Bergerone

Wallstent/Alberts5

Roubin

etal.6

CAVATAS7

Kentucky/B

rookse

Bonaldi9

KentuckyII/B

rook

Bibletal.11

SPACE12

MI,myocardialinfarc

Table II. Periprocedural outcomes within 30 days of CAS with EPD

Trial/author Year n TypeSymptoms(%) MI Stroke Death

CompositeMI/CVA/death Comment

Al-Mubarak et al.13 2002 162 Registry 48 0 1.0 1.0 2.0

Henry et al.14 2002 167 Registry 49 NR 2.2 0.6 2.7 Balloon occlusion for EPD (PercuSurge GuardWire system)

Cremonesi et al.15 2003 442 Registry 57 NR 2.0 0 2.0 CVA includes four patients with intracranial hemorrhage

CARESS16 2003 143 RCT 31 0 2.1 0 2.1 Carotid stenting with EPD equivalent to standard CEA

SAPPHIRE/Yadav et al.17,a 2004 167 RCT 30 2.4 3.6 1.2 4.8 CAS noninferior to CEA

CREST/Hobson et al.18 2004 749 Registry 31 NR 4.0 0.8 4.4 No EPD in 11.9% of patients treated early in series

ALKK/Zahn et al.19 2005 1,840 Registry 55 0 3.2 0.3 3.8 Hospital event rate (not 30-day). Contralateral ischemic events

in 1.4%. % patients with EPD not reported

Cremonesi20 2005 74 Registry 49 0 6.8 0 6.8

PRIAMUS/Coppi et al.21 2005 416 Registry 63 0 4.1 0.5 4.6 Proximal occlusion EPD (MO.MA device)

SECuRITY22 2005 305 Registry 21 0.7 6.9 1.0 7.5 Results never published in peer-reviewed journal

ARCHeR/Gray et al.23 2006 581 Registry 24 2.4 5.5 2.1 8.3

BEACH/White et al.24 2006 747 Registry 25 1.0 4.4 1.5 5.8

CREATE/Safian et al.25 2006 419 Registry 17 1.0 4.5 1.9 6.2 Predictors of CVA/death: symptomatic carotid stenosis (OR, 2.9),

renal insufficiency (OR, 2.9), filter deployment time

EVA-3S/Mas et al.26 2006 261 RCT 100 0.4 9.2 0.8 10.0 Trial stopped for safety and futility. Relative risk of CVA or

death 2.5 greater for stent than CEA

MAVErIC/Hill et al.27 2006 51 Registry NR 2.0 3.9 2.0 5.9

Setacci et al.28 2007 1,035 Registry 42 0.2 0.9 0.5 1.7 Single-center, retrospective review

CASES-PMS/Katzen et al.29 2007 1,493 Registry 22 0.8 3.8 1.0 5.0

CAPTURE/Gray et al.30 2007 3,500 Registry 14 0.9 4.8 1.8 6.3 Predictors of 30-day mortality: symptoms, age, use of multiple

stents, predilation before EPD

CABERNET/Hopkins et al.31 2008 454 Registry 24 0.4 3.6 0.4 4.0

Kastrup et al.32 2008 243 Registry 55 NR 5.8 0.4 6.2 EPD in 72%. Use of EPD reduced rate of new diffusion-weighted

imaging lesions on MRI

Pro-CAS/Theiss et al.33 2008 5,341 Registry 55 NR 3.5 0.4 3.6 Hospital event rate (not 30-day). No EPD in 24.8% of patients.

Sidawy et al.34 2009 1,450 Registry 45 1.2 3.5 2.1 5.7 Composite 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.35 2010 198 Registry 39 NR 2.0 0.5 2.5 MO.MA device. Proximal occlusion intolerance in 8.1%

ARMOUR/Ansel et al.36 2010 257 Registry 15 0 1.9 0.8 2.3 Roll-in + intention-to-treat population

ICSS/Ederle et al.37 2010 828 RCT 100 0.4 7.0 1.3 7.4 EPD in 72%

A meta-analysis of eight RCTs1,5,7,8,10,12,17,26 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 sixth12 used EPS in 27% of patients.aSAPPHIRE 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 >80.

290

Carotid

artery

stentin

gAnnalsofVascu

larSurgery

Table III. Peri-procedural outcomes within 30 days of CAS with EPD for asymptomatic and symptomatic patients

Trial/author Year

No symptoms Symptoms

Commentn MI Stroke DeathCompositeMI/CVA/death n MI Stroke Death

CompositeMI/CVA/death

Cremonesi et al.15 2003 136 NR 1.1 0 1.1 252 NR 1.2 0 1.2

Bibl et al.11 2005 166 NR 2.4 0.6 3.0 132 NR 3.1 0.8 4.7 No EPD

ALKK/Zahn et al.19 2005 802 0 NR NR 2.9 982 0 NR NR 4.7 p ¼ 0.048. Hospital event rate (not 30-day)

ARCHeR/Gray et al.23 2006 443 2.5 3.8 2.0 6.8 138 2.2 10.9 2.2 13.0 p for composite endpoint not reported

BEACH/White et al.24 2006 558 0.7 3.4 1.6 5.0 189 1.1 7.4 1.1 7.9 Stroke rate p ¼ 0.038. p for composite

endpoint not significant

CAPTURE/Gray et al.30 2007 3,018 0.8 4.1 1.3 5.4 482 1.7 8.9 4.8 12 p < 0.05 for composite endpoint

CASES-PMS/Katzen et al.29 2007 1,158 0.7 3.4 1.0 4.7 322 1.2 5.3 0.9 6.2

CABERNET/Hopkins et al.31 2008 344 0.6 2.7 0.6 3.3 110 0 6.4 0 6.4 Major stroke, p ¼ 0.03

Kastrup et al.32 2008 88 NR 3.4 0 3.4 87 NR 5.7 1.1 6.9

Pro-CAS/Theiss et al.33 2008 2,412 NR NR NR 2.7 2,921 NR NR NR 4.3 p ¼ 0.0019

Sidawy et al.34 2009 805 1.4 2.1 2.0 4.6 645 0.9 5.3 2.2 7.1 p ¼ 0.0014 for stroke; p ¼ 0.4 for

composite endpoint

Micari et al.35 2010 120 NR 1.7 0 1.7 78 NR 2.6 1.3 3.9

ICSS/Ederle et al.37 2010 828 0.4 7.0 1.3 7.4

Giacovelli et al.39 2010 4,353 NR 2.0 0.5 2.4 543 NR 5.7 3.7 8.3 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 2005-2007.

Vol.25,No.2,February

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Carotid

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g291

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 DeathCompositeMI/CVA/death MI �75 Stroke Death

CompositeMI/CVA/death

CREST18,a 2004 650/99 RCT NR 2.8 0.62 3.2 NR 12.1 0.8 12.1

Kastrup et al.40 2004 0/53 Registry NR NR NR NR 0 11.3 0 11.3

Longo et al.41,a 2005 129/29 Registry 0 2.3 0 2.3 0 3.4 0 3.4

ALKK, Zahn et al.42,b 2006 2,557/321 Registry 0.1 6.6 0.4 6.4 0.3 10.0 0.9 11.0

Kastrup et al.32 2008 138/37 Registry NR 3.6 0 3.6 NR 8.1 2.7 10.8

SPACE, Stingele et al.43 2008 469/138 RCT NR NR NR 5.7 NR NR NR 10.9

Bacharach et al.44,a 2010 147/78 Registry 0 1.9 0.6 2.5 0 3.9 0 3.9

Micari et al.35,a 2010 0/198 Registry NR 2.0 0.5 2.5

ARMOUR, Ansel et al.36,a 2010 155/65 Registry NR 1.9 NR 2.6 NR 3.1 NR 3.1

aAge cut-off is <80 versus �80.bComplications during in-hospital phase (not 30-day).

292

Carotid

artery

stentin

gAnnalsofVascu

larSurgery

Table V. Long-term outcomes after CAS in patients with EPD

Author Year n Type

Meanfollow-up(years) MI Stroke Death

CompositeMI/CVA/death Comment

CAVATAS7 2001 251 RCT 1.9 NR NR NR 14.3 PTA in 74%, PTA with bailout stenting in 26%

Henry et al.45 2002 167 Registry 0.9 1.2 0.6 1.8 1.8 Event-free survival 97% at 20 months

SAPPHIRE/Yadav et al.46 2004 167 RCT 1 3.0 6.2 7.4 12.0 CAS noninferior to CEA

ARCHeR/Gray et al.23 2006 437 Registry 1 NR 1.3 NR NR Ipsilateral stroke. Clinically driven TLR at 12 months

2.2%

MAVErIC/Hill et al.27 2006 51 Registry 1 5.9 5.9 3.9 11.8

Setacci et al.28 2007 442 Registry 3 NR NR NR 7.4 Single-center, retrospective review

SPACE47 2008 541 RCT 2 NR 10.9 6.3 10.5 Composite endpoint ipsilateral ischemic CVA

or vascular death

BEACH/Iyer at al.48 2008 447 Registry 1 0.2 4.5 1.6 8.9 BEACH pivotal group. 1-year restenosis rate (�70%

by duplex ultrasound) 8.9%; 1-year TLR 4.7%

SAPPHIRE/Gurm et al.46 2008 143 RCT 3 8.4 9.0 21.0 24.6 Long-term outcome after CAS and CEA similar

CABERNET/Hopkins et al.31 2008 424 Registry 1 0.5 4.7 0.5 4.7 Composite ¼ 30-day death, stroke, MI + 31-365 day

ipsilateral stroke

De Donato et al.49 2008 3,179 Registry 2.6 NR 8.1 18.0 NR 5-year outcomes. Death is all-cause mortality

CASES-PMS/Schreiber

et al.502010 1,492 Registry 1 2.9 5.4 8.1 12.5 No significant difference in outcome by symptom

status or high-risk status

MAVErIC I and

II/Higashida et al.512010 473 Registry 1 2.1 4.9 8.0 12.5 N ¼ 498 for intention-to-treat. TLR at 12 months

1.5%

ICSS/Ederle et al.37 2010 853 RCT 0.3 7.7 2.3 8.5 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.52 2010 454 Registry 3 7.1 7.2 17.7 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.53 2010 1,262 RCT 2.5 (median) NR 10.2 11.3 7.2 CAS and CEA associated with similar primary

outcomesdperiprocedural stroke, MI, or death and

subsequent ipsilateral strokedamong both

symptomatic

and asymptomatic patients

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2011

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