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To Stent or Not to Stent? Treatment of Carotid Artery Stenosis in the 21 st Century. Robert R. Carter MD April 21st 2010 Grand Rounds Department of Vascular Surgery University of Kentucky. Goals. Review history of carotid artery disease Summarize evidence for surgical intervention

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to stent or not to stent treatment of carotid artery stenosis in the 21 st century

To Stent or Not to Stent? Treatment of Carotid Artery Stenosis in the 21st Century

Robert R. Carter MD

April 21st 2010

Grand Rounds

Department of Vascular Surgery

University of Kentucky

goals
Goals
  • Review history of carotid artery disease
  • Summarize evidence for surgical intervention
  • Summarize trials that compare stenting and carotid endarterectomy (CEA)
  • Review FDA approved indications for stenting
slide3
1875
  • First report linking stroke with extra cranial vascular disease by Sir William Richard Gowers.
    • Described a patient with right hemiplegia and blindness in the left eye.
    • He attributed this syndrome to an occlusion of the left carotid artery in the patient’s neck.
slide4
1914
  • James Ramsay Hunt emphasized extra cranial carotid artery occlusive disease as a cause of stroke.
  • Urged examination of the cervical portion of the carotid artery during autopsy.
  • Suggested that transient cerebral ischemia was equivalent to intermittent claudication of the brain and represented a prodrome to a major stroke.
slide5
1937
  • Egas Moniz reported that arteriography could be used to diagnose carotid artery occlusion.
slide6

What is a TIA?

  • What is a Stroke?
  • How are they related?
transient ischemic attack tia
Transient Ischemic Attack (TIA)
  • Definition
    • Any transient neurologic deficit lasting from several seconds to many hours but not longer than 24 hours.
slide8
TIA
  • Two mechanisms
    • a brief vascular spasm in a partially blocked artery impedes blood flow to the brain temporarily
    • Small “mini” strokes where pieces of plaque dislodge and embolize
  • Not benign
    • Degree of cerebral atrophy and infarction linked to number of TIA’s
amaurosis fugax
Amaurosis Fugax
  • Definition
    • temporary monocular blindness (shade coming down over the eye) caused by embolization to the ophthalmic artery (first branch off the internal carotid artery)
    • TIA
    • Ulcerated plaque at common carotid bifurcation usual source
amaurosis fugax10
Amaurosis Fugax
  • Fundoscopic exam shows plaque traversing the retina
  • First described by Robert W. Hollenhorst in 1961
    • Hollenhorst bodies
stroke
Stroke
  • Definition
    • A sudden loss of brain function caused by an interruption in the supply of blood to the brain. A ruptured blood vessel or cerebral thrombosis may cause the stroke, which can occur in varying degrees of severity from temporary paralysis and slurred speech to permanent brain damage and death.
    • Neurologic deficit lasts longer than 24 hours
how are tia and stroke related
How are TIA and stroke related?
  • 35% of patients with a TIA will have a stroke in their lifetime
    • 50% of these will occur in the year following first TIA
  • After first year stroke risk is 5% per year
stroke13
Stroke
  • 3rd leading cause of death in the united states
  • 2nd most common cause of cardiovascular death
  • #1 cause of death from a neurologic disorder
stroke15
Stroke
  • Incidence of new stroke is 160/100,000
  • Annual financial impact estimated to be $45.3 billion/year
    • Death
    • Disability
      • Long term care
      • Medical expenses
      • Inability to return to previous employment
stroke16
Stroke
  • Prognosis
    • 80% survive initial event
      • 29% regain normal function
      • 36% return to work
      • 18% unable to work, but can take care of themselves
      • 4% require custodial care
  • Natural history
    • only 50% of stroke victims will be alive at five years.
slide17

Is TIA a risk factor for stroke?

    • 33% of TIA patients will suffer a stroke within 5 years, 17% within 1 year
  • What about asymptomatic carotid stenosis?
outcome in patients with asymptomatic neck bruits 1986
Outcome in patients with asymptomatic neck bruits 1986
  • NEJM
    • prospectively followed 113 asymptomaticpatients with carotid stenosis ≥ 75% (Doppler)
    • 1 year 18% had ischemic cerebrovascular events over ¼ of these events strokes (5.5%)
    • At 2 years 22% had ischemic cerebrovascular events
    • In patients with less than 75% stenosis
      • 1 year 3%
      • 2 years 6%

Chambers BR, Norris JW. Outcome in patients with asymptomatic neck bruits. N Engl J Med 1986;315:860-865

slide20

What is the risk of stroke with asymptomatic carotid stenosis?

    • With ≥ 75% asymptomatic stenosis, 22% of patients will have an ischemic cerebrovascular event at 2 years
  • What can we do about it?
medical treatment
Medical Treatment
  • Both systolic and diastolic blood pressure independently related to stroke incidence
    • 6mm reduction in DBP produces 42% reduction in stroke rate
    • Tx of isolated systolic hypertension in patients over 60 reduces stroke incidence by 32%
  • Smoking cessation
    • Relative risk 1.5-2.2
  • Serum lipid levels
    • have not been shown to affect stroke rate but low levels slow progression of atherosclerosis

Biller J, Feinberg WM, Castaldo JE, et al. Guidelines for carotid endarterectomy: a statement for healthcare professionals from a special writing group of the stroke council, american heart association. Circulation 1998;97:501-509

medical treatment22
Medical Treatment
  • Alcohol consumption
    • Heavy alcohol use associated with excessive stroke risk
    • Moderate consumption may have no or a slightly protective effect
  • Antiplatelet therapy
    • 23% reduction in stroke with aspirin compared to placebo in patients with history of TIA/stroke
    • Also 22% reduction in MI/death

Biller J, Feinberg WM, Castaldo JE, et al. Guidelines for carotid endarterectomy: a statement for healthcare professionals from a special writing group of the stroke council, american heart association. Circulation 1998;97:501-509

slide23
CEA
  • Carotid Endarterectomy
    • Surgical removal of the inner layer of the carotid artery when narrowed by atheromatous intimal plaques
slide24
1953
  • KJ Strully attempted (unsuccessfully) to operate on an occluded carotid artery.
slide25
1954
  • First successful extra cranial carotid surgery preformed by Felix Eastcott.
  • Patient with episodes of hemispheric cerebral ischemic attacks and an atherosclerotic lesion at the carotid bifurcation.
  • Treated with resection and primary anastomosis.

Eastcott HHG, Pickering GW, Rob CG. Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia. Lancet 1954;2:994-6.

slide26
1953?
  • Michael DeBakey published a similar operative case preformed prior to Eastcott’s case.
  • However his report was published after Eastcott’s case and thus Eastcott is credited with bringing the possibility of carotid artery repair to medical attention.
slide27
1966
  • Drs. Stanley Crawford and Michael DeBakey credited with first describing carotid endarterectomy in 1966. (although DeBakey claimed to have preformed it in 1953)
cooley
Cooley
    • Dr. Denton Cooley is credited with being the first to use an intravascular shunt during carotid surgery
  • Professional rivalry with DeBakey that lasted 40 years, made public amends November 7, 2007 at ages 99 and 87
cooley29
Cooley
  • When asked by a Lawyer if he considered himself the best heart surgeon in the world he answered in the affirmative.
  • The lawyer then asked if he thought he was being rather immodest?
  • Cooley replied, “Perhaps, but remember I am under oath.”
slide30

Does medical therapy decrease risk of stroke?

    • Smoking cessation, BP control, etoh in moderation and antiplatelet therapy all reduce stroke risk
  • What about CEA?
nascet 1991
NASCET 1991
  • North American Symptomatic Carotid Endarterectomy Trial (50 centers US and Canada)
    • TIA or non disabling stroke within 120 days with 30-99% stenosis
    • Patients randomized to medical or surgical therapy
    • Patients symptomatic with high grade lesions

(70 - 99% stenosis), 659 patients, <80 years old

    • Results
      • 24% medically managed patients had stroke within 18 months
      • 7% surgical patients had a stroke
    • Rate of perioperative major stroke/death was 2.1% in this trial

Nascet C. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1991;325:445-53

nascet 199132
NASCET 1991
  • Study stopped early
  • Risk reduction at 2 years
    • 12% 70-79% stenosis
    • 18% 80-89% stenosis
    • 26% 90-99% stenosis
  • Conclusion
    • CEA highly beneficial to patients with recent hemispheric and retinal transient ischemic attacks or non disabling strokes and ipsilateral high-grade stenosis (70-99%) of the internal carotid artery.
carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis 1991
Carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis 1991
  • 189 symptomatic patients >50% ipsilateral stenosis at 16 VA hospitals
  • Randomized to CEA or medical management
  • At 1 year
    • 7.7% stroke/TIA rate in CEA group
    • 19.4% stroke/TIA rate in medical group

Mayberg MR, Wilson SE, Yatsu F, et al. Carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis. JAMA 1991;266:3289-3294.

nascet 1998
NASCET 1998
  • Does CEA benefit symptomatic pts with stenosis <70%
  • Any ipsilateral stroke at 5 years
    • 50-69% stenosis
      • 15.7% CEA
      • 22.2% medical
    • <50% stenosis
      • 14.9% CEA
      • 18.7% medical (not statistically significant)
nascet 199838
NASCET 1998
  • CEA in symptomatic patients with 50-69% yields only moderate reduction in risk of stroke and provided no benefit to patients with <50% stenosis.
  • Patients with ≥70% stenosis had durable benefit at eight years.
slide39

Can CEA reduce the stroke risk in symptomatic patients?

    • CEA reduces the risk of any stroke from 25% to 10% at two years in patients with symptomatic stenosis of ≥ 70% (NASCET)
  • Can CEA reduce the stroke risk in asymptomatic patients?
veterans affairs trial 1993
Veterans Affairs Trial, 1993
  • Asymptomatic Carotid Stenosis Veterans Administration Study
    • 11 centers, 1983-1991
    • 444 men with asymptomatic carotid stenosis
    • 50% stenosis or more (angiogram)
    • Evaluated combined incidence of TIA, Amaurosis Fugax, and stroke
    • Randomized to optimal medical treatment alone vs. optimal medical treatment plus carotid endarterectomy

Hobson RW 2nd, Weiss DG, Fields WS, Goldstone J, Moore WS, Towne JB, Wright CB. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group. N Engl J Med. 1993 Jan 28;328(4):221-7.

veterans affairs trial 199341
Veterans Affairs Trial, 1993
  • All patients followed for an average of 48 months
  • Incidence of ipsilateral neurologic events
    • 8% CEA
    • 20.6% medical group
  • Stroke/death rate within 30 days not different between groups
veterans affairs trial 199342
Veterans Affairs Trial, 1993

Incidence of Neurologic End Points for Ipsilateral Events.

veterans affairs trial 199343
Veterans Affairs Trial, 1993

Kaplan-Meier Curves for Event-free Rates of First Ipsilateral Stroke and Transient Ischemic Attack Including Transient Monocular Blindness.

acas 1995
ACAS, 1995
  • Asymptomatic Carotid Artery Study
    • Prospective randomized trial
    • 39 sites in the US and Canada
    • 1987-1993, 1662 patients with asymptomatic carotid artery stenosis 60% or greater
    • Daily aspirin administration and medical risk factor management for all patients
    • Medical vs. carotid endarterectomy

Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for Asymptomatic Carotid Artery Stenosis. JAMA, 273(18), 10 May 1995, pp 1421-1428

acas 199545
ACAS, 1995
  • Outcomes
    • Cerebral infarction occurring in the distribution of the study artery, any stroke or death
    • Perioperative risk
      • 30 days post op 2.3% in the surgery group
      • 42 days post randomization 0.4% in the medical group
    • Median follow-up 2.7 years
    • Combined risk of outcomes
      • 5.1% CEA
      • 11% medical management
slide50

Can CEA reduce the stroke risk in asymptomatic patients?

    • CEA reduces the risk of any stroke or death from 11% to 5% at five years in patients with asymptomatic stenosis of ≥ 60% (ACAS)
  • What about stenting?
carotid angioplasty and stenting
Carotid angioplasty and stenting
  • The first case reports of carotid artery angioplasty were reported in the early 1980s.
carotid angioplasty and stenting52
Carotid angioplasty and stenting
  • The first large series of carotid angioplasty and stenting was reported by Roubin et.al. in 1996
    • They preformed angioplasty in 107 patients deemed too medically/anatomically unstable to undergo endarterectomy.
    • 10% combined stroke/death rate

Roubin GS, Yadav S, Lyer SS, et al. Carotid stent supported angioplasty: a neurovascular intervention to prevent stroke. Am J Cardiol 1996;78:8-12.

carotid angioplasty and stenting53
Carotid angioplasty and stenting
  • In 2000 a large multicenter report (14 groups) in which 358 arteries in 338 patients with restenosis after CEA was published.
    • 5 year follow-up
    • Stroke rate 3.7%
    • Mortality 1.1%
    • Adverse events 4%

New G, Roubin GS, Iyer SS, et al. Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study. J Endovascul Ther 2000;7:345-352.

carotid angioplasty and stenting54
Carotid angioplasty and stenting
  • In 2001 Mathias et al. presented data on over 3,000 carotid artery stents (CAS).
    • Stroke rate 2%
    • Complication rate 3%
  • These and other series demonstrated that stenting could be preformed with an acceptable complication rate.

Mathias K, Jager H, Hennigs S, et al. Endoluminal treatment of internal carotid artery stenosis. World J Surg 2001;25:328-334.

slide55

What about stenting?

    • Large series of CAS have shown that stenting can be preformed with an acceptable complication rate
  • But is stenting equivalent to CEA?
slide56

3 types of studies available to review efficacy of stenting

    • Case series
    • Industry sponsored registries
    • Randomized trials
case series
Case Series
  • 51% patients symptomatic
  • >97% successfully stented
  • 64% evaluated by neurologist
  • After 2002 embolic protection devices (EPDs) widely utilized
filters
Filters
  • Filter wire
  • Interceptor
  • Angioguard
  • Accunet
  • Emboshield
case series60
Case Series
  • Stroke rate 1% - 8% (lower with experience and EPD use)
  • Overall 30 day stroke rate 3%
  • Overall 30 day stroke/MI/death rate 4%
  • Early restenosis rates 1%-8% (reported in half the series)
industry sponsored registries of cas62
Industry-sponsored registries of CAS
  • Presented at national meetings but not published in peer reviewed journals
  • 30 day stroke rates 2%-7%
  • 30 day stroke, MI, death rates 3%-8%
  • 27% of patients symptomatic
randomized trials
Randomized trials
  • All used independent neurologist examinations
  • After 2001, all used EPDs
caress 2003
CARESS 2003
  • Not really a randomized trial
    • CARESS assigned patients to CAS or CEA based on “selection criteria reflective of broad clinical practice”
      • Equivalence cohort
      • 397 patients

CARESS Steering Committee. Carotid Revascularization Using Endarterectomy or Stenting Systems (CARESS): Phase I Clinical Trial. J Endovasc Ther 2003;10:1021-1030

caress 200366
CARESS 2003
  • CEA vs. CAS with embolic protection
  • ≥ 50% symptomatic stenosis
  • ≥ 75% asymptomatic stenosis
  • 30 day mortality, stroke and MI rate
    • CEA 3%
    • CAS 2%
  • 30 day mortality and stroke rate
    • CEA 2%
    • CAS 2%

CARESS Steering Committee. Carotid Revascularization Using Endarterectomy or Stenting Systems (CARESS): Phase I Clinical Trial. J Endovasc Ther 2003;10:1021-1030

caress 200367
CARESS 2003
  • Lowest stroke/complication rates for both CAS and CEA across all trials
    • Careful patient selection may be one of the most important determinants of outcome for both CAS and CEA

CARESS Steering Committee. Carotid Revascularization Using Endarterectomy or Stenting Systems (CARESS): Phase I Clinical Trial. J Endovasc Ther 2003;10:1021-1030

sapphire 2004
SAPPHIRE 2004
  • Stenting and Angioplasty with Protection for Patients at HIgh Risk for Endarterectomy (SAPPHIRE) trial
    • Data at 30 days and 1 year
    • EPDs used on all patients
    • 334 patients

≥ 50% symptomatic stenosis

≥ 80% asymptomatic stenosis

Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid artery stenting verses endarterectomy in high-risk patients. N Engl J Med 2004; 351:1493-1501.

sapphire 200469
SAPPHIRE 2004
  • Stenting and Angioplasty with Protection for Patients at HIgh Risk for Endarterectomy (SAPPHIRE) trial
    • Data at 30 days and 1 year
    • EPDs used on all patients
    • 334 patients

≥ 50% symptomatic stenosis

≥ 80% asymptomatic stenosis

Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid artery stenting verses endarterectomy in high-risk patients. N Engl J Med 2004; 351:1493-1501.

sapphire 200470
SAPPHIRE 2004
  • SAPPHIRE
    • High risk for CEA
      • Clinically significant heart disease
      • Severe pulmonary disease
      • Contralateral carotid occlusion
      • Contralateral laryngeal nerve palsy
      • Previous radical neck surgery or radiation therapy
      • Recurrent stenosis after CEA
      • Age > 80 years

Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid artery stenting verses endarterectomy in high-risk patients. N Engl J Med 2004; 351:1493-1501.

sapphire 200471
SAPPHIRE 2004
  • SAPPHIRE
    • High risk for CEA
      • Clinically significant heart disease
      • Severe pulmonary disease
      • Contralateral carotid occlusion
      • Contralateral laryngeal nerve palsy
      • Previous radical neck surgery or radiation therapy
      • Recurrent stenosis after CEA
      • Age > 80 years

Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid artery stenting verses endarterectomy in high-risk patients. N Engl J Med 2004; 351:1493-1501.

sapphire 200472
SAPPHIRE 2004
  • SAPPHIRE
    • Randomized to CEA or CAS
    • 30 day stroke/MI/death rate
      • 4.4% CAS
      • 9.8% CEA
    • 1 year stroke/MI/death rate
      • 12% CAS
      • 20% CEA
    • High rates in CEA group secondary to high risk patients
    • Conclusion CAS with EPD not inferior to CEA in high risk patients

Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid artery stenting verses endarterectomy in high-risk patients. N Engl J Med 2004; 351:1493-1501.

sapphire 200476
Flaws with SAPPHIRE

Supported by Cordis Corp. manufacturer of stent used in study (Smart stent with Angioguard)

747 pts evaluated only 334 randomized (406 entered into stent registries, 7 referred for CEA)

Stopped after 334 pts out of planned 2,900 pts enrolled due to “competing nonrandomized registries”

Troponin based MI

“non-Q-wave MI have 27 fold increased risk of MI in the next 6 months”

This was not borne out in the long-term outcomes

SAPPHIRE 2004

Gurm, HS, Yadav JS, Fayad, P M.D.et.al.Long-Term Results of Carotid Stenting versus Endarterectomy in High-Risk Patients. N. Engl. J. Med. 2008;358:1572-9

sapphire 200479
SAPPHIRE 2004
  • SAPPHIRE was used to gain FDA approval of the Cordis stent
    • 6 cardiologists, 2 interventional radiologists, 2 vascular surgeons, 1 neurologist on panel
    • Approved 6 to 5
sapphire 2008
SAPPHIRE 2008
  • 3 year data, primary endoints plus death or ipsilateral stroke at 3 years
    • 24.6% CAS
    • 26.9% CEA
  • 15 strokes in each group
    • 11 ipsilateral in the CAS group
    • 9 ipsilateral in the CEA group
  • Conclusion – no difference in longterm outcome
space 2006
SPACE 2006
  • Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs. Endarterectomy (SPACE) collaborative group
    • Hypothesis was “that carotid-artery stenting is not inferior to carotid endarterectomy for the treatment of severe symptomatic carotid stenosis”
    • Endpoints
      • Ipsilateral stroke, intracerebral bleeding, or death within 30 days
    • 1,183 symptomatic patients randomized to CAS or CEA
      • ≥ 50% stenosis
      • Low risk surgical patients

Group SC, Ringleb PA, Allenberg J, et al. 30 day results from the SPACE trial of stent-protected angioplasty verses carotid endarterectomy in symptomatic patients: a randomised noninferiority trial. Lancet 2006;368:1239-1247.

space 200686
SPACE 2006
  • Rate of death/ipsilateral stroke at 30 days
    • 6.84% CAS
    • 6.34% CEA
  • Had same stroke/death rate in patients treated with and without embolic protection (27% of stented patients had EPD)
  • Stroke rate with continued deficits
    • 4% CAS
    • 2.9% CEA
  • Conclusion failed to prove noninferiority of CAS vs CEA

Group SC, Ringleb PA, Allenberg J, et al. 30 day results from the SPACE trial of stent-protected angioplasty verses carotid endarterectomy in symptomatic patients: a randomised noninferiority trial. Lancet 2006;368:1239-1247.

slide90

1. Age >75 higher risk both CEA and CAS but increased more in CAS group

2. Female patients higher risk in CAS group

slide91

1. Age >75 higher risk both CEA and CAS but increased more in CAS group

2. Female patients higher risk in CAS group

eva 3s 2006
EVA-3S 2006
  • Endarterectomy vs. Angioplasty in Patients with Symptomatic Severe carotid Stenosis (EVA-3S) (Paris)
    • 527 high-risk patients with ≥ 60% symptomatic stenosis
    • randomized to CAS or CEA
    • 30 day stroke/death rate
      • 3.9% CEA
      • 9.6% CAS
    • 6 month stroke/death rate
      • 6.1% CEA
      • 11.7% CAS
  • Conclusion stroke/death rate after CEA lower than after CAS in this population.
  • Study stopped early for “reasons of safety and futility”

Mas J-L, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355:1660-1671.

crest 2004
CREST 2004
  • Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)
    • Randomized trial CEA vs. CAS in low risk patients with symptomatic ≥ 50% stenosis and asymptomatic ≥ 70% stenosis
    • Lead in phase of this study
      • 749 patients underwent CAS (31% symptomatic)
      • 30 day stroke/death rate higher with age ≥ 80 years
        • 12.1% in patients ≥ 80 years
        • 3.2% in patients < 80 years
  • Care should be taken when CAS is preformed on elderly patients

Hobson RW, 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; 40:1106-1112

crest 2010
CREST 2010
  • On February 26, 2010 presented results at the American Stroke Association’s Annual International Stroke Conference
  • Now 2,502 patients at 2.5 years
    • Stroke rate
      • CEA 2.3%
      • Stent 4.1%
    • MI rate (don’t state criteria for MI)
      • CEA 2.3%
      • Stent 1.1%
crest 201099
CREST 2010
  • "The data from the landmark CREST trial has shown that there was no difference between CAS and CEA in this large group of symptomatic and asymptomatic patients. From a practitioner's point of view, we and our patients now have a choice in terms of what type of revascularization therapy might be best for them," said Barry Katzen, MD, Founder and Medical Director of Baptist Cardiac and Vascular Institute and Clinical Professor of Radiology at the University of South Florida College of Medicine in Florida.
crest 2010100
CREST 2010
  • Christopher J. White, MD, Chairman, Department of Cardiovascular Diseases, Ochsner Clinic Foundation in New Orleans, Louisiana said, "I think this is clearly a game changer for carotid stenting. It is going to bring reimbursement. It is going to bring choice for our patients, especially in the seniors (the Medicare population) who are being forced to have surgery. I think many good things are going to come out of this."
icss 2009
ICSS 2009
  • International Carotid Stenting Study (ICSS)
    • Randomized 1710, ≥ 50% stenosis, symptomatic patients
    • 30 day safety data showed
      • Twice as many strokes for CAS vs. CEA ( 7.0% vs. 3.3%)
      • Confirmed by blinded MRI
      • any stroke, death or perio‐op MI, CAS vs. CEA (8.5% vs. 5.1%)
      • presented to the ICSS Investigators Meeting on 05/22/09
    • Awaiting longterm results

http://www.cavatas.com/

act i
ACT I
  • Asymptomatic Carotid Trial (ACT I)
    • Randomize asymptomatic patients standard risk for surgery
    • ≥ 70% stenosis
    • Currently enrolling patients

http://www.act1trial.com

fda approved devices
FDA Approved Devices
  • SAPPHIRE trial by Cordis
    • FDA approval of angioguard system in April 2004
  • ARCHeR registry by Guidant
    • FDA approval for Accunet/Acculink system in August 2004
  • SECURITY registry by Abbott
    • FDA approval for Xact/Emboshield system in September 2005
fda approved devices108
FDA Approved Devices
  • Symptomatic patients with ≥ 50% ICA stenosis or asymptomatic patients with ≥ 80% ICA stenosis
  • Patients must also be considered high risk for CEA
fda approved devices109
FDA Approved Devices
  • Symptomatic patients with ≥ 50% ICA stenosis or asymptomatic patients with ≥ 80% ICA stenosis
  • Patients must also be considered high risk for CEA
high risk for cea
“High risk for CEA”
  • High medical risk
    • Severe coronary artery disease
    • Severe pulmonary disease
    • End stage renal disease
    • Uncontrolled diabetes
  • High anatomic risk
high risk for cea111
“High risk for CEA”
  • High medical risk
    • Severe coronary artery disease
    • Severe pulmonary disease
    • End stage renal disease
    • Uncontrolled diabetes
  • High anatomic risk
    • Contra lateral ICA occlusion
    • Radiation therapy to the neck
    • Distal ICA stenosis
    • Spinal immobility
    • Tracheostomy
    • Contra lateral laryngeal nerve paralysis
medicare medicaid reimbursement114
Medicare/Medicaid Reimbursement
  • Only FDA approved devices
  • Only treatment of symptomatic, high risk patients with > 70% stenosis in Medicare/Medicaid approved centers
  • Will reimburse for high risk symptomatic patients with 50-69% stenosis and asymptomatic patients with > 80% stenosis only if enrolled in an approved clinical trial
so what do we know
So what do we know?
  • Is TIA a risk factor for stroke?
    • 33% of TIA patients will suffer a stroke within 5 years, 17% within 1 year
  • What about asymptomatic carotid stenosis?
    • With ≥ 75% asymptomatic stenosis, 22% of patients will have an ischemic cerebrovascular event at 2 years
  • Does medical therapy decrease risk of stroke?
    • Smoking cessation, BP control, etoh in moderation and antiplatelet therapy all reduce stroke risk
  • Can CEA reduce the stroke risk in symptomatic patients?
    • CEA reduces the risk of any stroke from 25% to 10% at two years in patients with symptomatic stenosis of ≥ 70% (NASCET)
  • Can CEA reduce the stroke risk in asymptomatic patients?
    • CEA reduces the risk of any stroke or death from 11% to 5% at five years in patients with asymptomatic stenosis of ≥ 60% (ACAS)
so what do we know116
So what do we know?
  • What about stenting?
    • Large series of CAS have shown that stenting can be preformed with an acceptable complication rate
  • But is stenting equivalent to CEA?
    • Current evidence does not support a change from the recommendation of carotid endarterectomy as the standard of care for carotid stenosis
  • Has the FDA approved any stent systems? Does Medicare pay for stenting?
    • Three FDA approved stents, only for symptomatic patients with ≥ 50% ICA stenosis or asymptomatic patients with ≥ 80% ICA stenosis, also must be considered high risk for CEA
    • Medicare only pays for stenting of symptomatic > 70% stenosis outside of trials
so what do we know117
So what do we know?
  • What about stenting?
    • Large series of CAS have shown that stenting can be preformed with an acceptable complication rate
  • But is stenting equivalent to CEA?
    • Current evidence does not support a change from the recommendation of carotid endarterectomy as the standard of care for carotid stenosis
  • Has the FDA approved any stent systems? Does Medicare pay for stenting?
    • Three FDA approved stents, only for symptomatic patients with ≥ 50% ICA stenosis or asymptomatic patients with ≥ 80% ICA stenosis, also must be considered high risk for CEA
    • Medicare only pays for stenting of symptomatic > 70% stenosis outside of trials
conclusions
Conclusions
  • As with other minimally invasive surgical procedures, CAS has developed rapidly over the last decade
  • Equivalence with CEA has been established only in high-risk patients?
  • The effectiveness in lower-risk patients has not yet been determined
conclusions119
Conclusions
  • The choice of CAS vs. CEA is primarily based on individual practitioner experience rather than on clear evidence-derived guidelines
  • Increased utilization of CAS has been promoted by the popularity of “minimally invasive procedures” as well as the marketing of CAS system developers
  • Ongoing randomized trials will help determine optimal carotid revascularization strategies in the future
references
References
  • Roubin GS, Yadav S, Lyer SS, et al. Carotid stent supported angioplasty: a neurovascular intervention to prevent stroke. Am J Cardiol 1996;78:8-12.
  • Mathias K, Jager H, Hennigs S, et al. Endoluminal treatment of internal carotid artery stenosis. World J Surg 2001;25:328-334.
  • Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid artery stenting verses endarterectomy in high-risk patients. N Engl J Med 2004; 351:1493-1501.
  • Group SC, Ringleb PA, Allenberg J, et al. 30 day results from the SPACE trial of stent-protected angioplasty verses carotid endarterectomy in symptomatic patients: a randomised noninferiority trial. Lancet 2006;368:1239-1247.
  • Mas J-L, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355:1660-1671.
  • CARESS Steering Committee. Carotid Revascularization Using Endarterectomy or Stenting Systems (CARESS): Phase I Clinical Trial. J Endovasc Ther 2003;10:1021-1030
  • Hobson RW, 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; 40:1106-1112
  • http://www.cavatas.com/
  • http://www.ptca.org/pr_abbott/20050118.html
  • Kastrup A, Gröschel K, Krapf H, Brehm BR, et al. Early Outcome of Carotid Angioplasty and Stenting With and Without Cerebral Protection Devices: A Systematic Review of the Literature. Stroke 2003;34:813-819
  • http://www.cardiologytoday.com/view.aspx?rid=33027
  • http://www.invatec.com/tool/home.php?s=0,1,55,59,204
  • Hart JP, Peeters P, Verbist J, et al. Do device characteristics impact outcome in carotid artery stenting? J Vasc Surg 2006:44;725-730
  • Crawford ES, DeBakey ME, Garrett HE, Howell J. Surgical treatment of occlusive cerebrovascular disease. Surg Clin North Am. 1966;46:873-884
  • Cooley DA, Al-Naamanyd, Carton CA. Surgical treatment of arteriosclerotic occlusion of common carotid artery. J Neurosurg. 1956;13:500-506
  • Mayberg MR, Wilson SE, Yatsu F, et al. Carotid endarterectomy and prevention of cerebral ischemia in symptomatic carotid stenosis. JAMA 1991;266:3289-3294.
  • http://www.cdc.gov/
  • Biller J, Feinberg WM, Castaldo JE, et al. Guidelines for carotid endarterectomy: a statement for healthcare professionals from a special writing group of the stroke council, american heart association. Circulation 1998;97:501-509
  • Stoner MC, Abbott WM, Wong DR, et al. Defining the high risk patient for carotid endarterectomy: an analysis of the prospective National Surgical Quality Improvement Program database. J Vasc Surg 2006;43:285-295.
  • New G, Roubin GS, Iyer SS, et al. Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study. J Endovascul Ther 2000;7:345-352.
  • Nascet C. Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1991;325:445-53
  • Hobson RW 2nd, Weiss DG, Fields WS, Goldstone J, Moore WS, Towne JB, Wright CB. Efficacy of carotid endarterectomy for asymptomatic carotid stenosis. The Veterans Affairs Cooperative Study Group. N Engl J Med. 1993 Jan 28;328(4):221-7.
  • Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for Asymptomatic Carotid Artery Stenosis. JAMA, 273(18), 10 May 1995, pp 1421-1428
  • Gray WA, Hopkins LN, Yadav S, Thomas D, et al. Protected carotid stenting in high-surgical-risk patients: The ARCHeR results. J Vasc Surg 2006;44:258-69.
  • Eastcott HHG, Pickering GW, Rob CG. Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia. Lancet 1954;2:994-6.
  • Gurm, HS, Yadav JS, Fayad, P M.D.et.al.Long-Term Results of Carotid Stenting versus Endarterectomy in High-Risk Patients. N. Engl. J. Med. 2008;358:1572-9
slide124

Multiple reports on CEA stroke/death rates for octogenarians reveal no increased risk at 30 days vs. younger population (1.9-4.4% vs 1.7-4.2%)

  • However multiple reports on CAS seem to suggest a much higher rate of 30 day stroke, mi and death in this population (25% compared to 8.2%)
  • Yet other reports show no difference
high risk patients
High risk patients
  • Multiple studies show a 30 day stroke rate of 1-2% even in high risk patients with CEA
  • CEA may be performed under local anesthesia with a significant reduction in stroke/mortality/MI in high risk patients

Stoner MC, Abbott WM, Wong DR, et al. Defining the high risk patient for carotid endarterectomy: an analysis of the prospective National Surgical Quality Improvement Program database. J Vasc Surg 2006;43:285-295.

non filter embolic protection devices
Non-Filter Embolic Protection Devices
  • Balloons
  • Flow reversal devices
guardwire by medtronic
Guardwire by Medtronic
  • Balloon placed distal to lesionfor transient occlusion during angioplasty/stent placement
  • Allows recovery of any liberated plaqueby aspiration before restoration of antegrade flow
  • May form distal thrombus
  • Originally developed for coronary stent placement
moma device
MOMA Device
  • Invatec device
  • ARMOUR trial to be completed in 2009.
    • 25 U.S. and European sites
    • hope for FDA approval by the end of 2009

Balloon in external carotid

Stent placement and aspirate debris through port

Balloon in common carotid

http://www.cardiologytoday.com/view.aspx?rid=33027

http://www.invatec.com/tool/home.php?s=0,1,55,59,204

parodi device by gore
Parodi Device by Gore
  • Reversing of blood flow at the treatment site
  • Liberated emboli directed away from the brain
  • Selective occlusion of the common carotid and external carotid arteries
  • Shunt between the carotid artery and femoral vein
  • Blood from the opposite side of the brain via the Circle of Willis and collateral vessels is redirected to the lower pressure venous return
  • Embolic particles are captured in a filter outside the body.
parodi device by gore131
Parodi Device by Gore
  • EMPiRE (Embolic Protection with flow Reversal) Clinical Study
    • Started July 2006
    • designed to demonstrate the safety and efficacy of the GORE Neuro Protection System when used for embolic protection during carotid artery stenting procedures
slide132
EPDs
  • 2003 review of the literature by Kastrup found
    • A 3-fold increased rate of 30 day stroke/death without protection compared with protection.
    • A 6-fold increase of minor stroke within 30 days of CAS without protection compared with protection.

Kastrup A, Gröschel K, Krapf H, Brehm BR, et al. Early Outcome of Carotid Angioplasty and Stenting With and Without Cerebral Protection Devices: A Systematic Review of the Literature. Stroke 2003;34:813-819

stent design
Stent Design
  • Open Cell more flexible
    • conforming
  • Closed Cell stiffer
    • Scaffold and support fractured plaque better
    • Keep thrombogenic material away from lumen
filter design
Filter Design
  • Eccentric filters
    • Filter placed eccentrically on wire
    • Better wall apposition leads to better TIA prevention
  • Concentric filters
    • Filter placed concentrically on wire
fda approved devices135
FDA Approved Devices
  • FDA approval compared CAS system to estimated CEA 30 day stroke/death/MI and 1 year ispsilateral stroke rates in high risk patients of 14.5%.
slide136
Hart JP, Peeters P, Verbist J, et al. Do device characteristics impact outcome in carotid artery stenting? J Vasc Surg 2006:44;725-730
archer
ARCHeR

Gray WA, Hopkins LN, Yadav S, Thomas D, et al. Protected carotid stenting in high-surgical-risk patients: The ARCHeR results. J Vasc Surg 2006;44:258-69.