CEA Works Well! Large Amounts of Data! UNKNOWN 1 NASCET ECST - - PDF document

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CEA Works Well! Large Amounts of Data! UNKNOWN 1 NASCET ECST - - PDF document

Jun 25, 2023 314 likes •456 views

QUESTIONS Is carotid artery stenting (CAS) FEASABLE ? Carotid Endarterectomy Is it SAFE ? 1954 - 2006 What are the RESULTS and what are the INDICATIONS ? Is carotid endarterectomy (CEA) DEAD? Is carotid endarterectomy (CEA)

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SLIDE 1

1

QUESTIONS

  • Is carotid artery stenting (CAS)

FEASABLE ?

  • Is it SAFE ?
  • What are the RESULTS and what are

the INDICATIONS ?

  • Is carotid endarterectomy (CEA)

DEAD?

Carotid Endarterectomy 1954 - 2006

Is carotid endarterectomy (CEA) DEAD?

CEA

1950 1970-80 1994

ACST ACAS ECST NASCET

≈12,000 pts

50% RRR

Risk reduction / % stenosis

ARR @ 5 yrs N % STENOS Pooled Trials 4072 6092

5.5%

>60% ASYMPTO ACAS + ACST

16%

70-99% SYMPTO

4.6%

50-69% SYMPTO NASCET+ECST+VA

CEA

Works Well!

Large Amounts of Data!

UNKNOWN

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SLIDE 2

2

CEA

1950 1970-80 1994

ACST ACAS ECST NASCET

C Angioplasty CAS

E P D

2000 Le Roi STENT LE TRONE DU STENT CAROTIDIEN

1 Stent Eradicates 10.000 Vascular Surgeons

CAS

IS IT FEASABLE ? IS IT SAFE ?

Literature Review

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SLIDE 3

3

Literature Review

  • Leicester
  • Wall stent
  • Kentucky
  • CAVATAS
  • Non-randomized

case series

  • SAPPHIRE
  • Non-randomized

case series

  • CREST
  • ICSS
  • EVA – 3s
  • SPACE

BEFORE EPD AFTER EPD

On – going TRIALS

Leicester 1998, UK

29 patients, ∑ >70% F/U 1 mo Stroke/Death/HITs D30

Endovacular Surgery 6 excluded

JVS 1998 S t

  • p

p e d b y d a t a m

  • n

i t

  • r

i n g c

  • m

m i t t e e a t t h e f i r s t i n t e r i m a n a l y s i s

5/7 strokes

Wallstent 2001, USA

219 pts, ∑>60% F/U 1,12 mo Stroke/Death/MI D30

Endovascular 12.1% (1 yr) Surgery 3.6% (1 yr) No protection devices

<

Ticlopidine

Abandoned by commercial sponsors

  • No protection devices used
  • Lack of experience of interventionalists
  • Stent primarily not dedicated to carotid

artery

  • Stroke and MI rates > CEA group
  • Prematurely arrested
  • Abandoned by commercial sponsors

Wallstent 2001 Kentucky 2001, USA

104 patients, ∑ >70% F/U 1,3,6,12,24 mo Stroke/Death/Restenosis

Endovacular 1/53 TIA Surgery 1/53 MI No protection devices Limited series Clopidogrel

=

JACC 2001

CAVATAS 2001

Europe, Australia, Canada

504 patients, ∑/a∑ F/U 1,6,12,60 mo Stroke / Death D30 Endovacular 251 Surgery 253

Recruitement 1992-1997 Pre 1994 (74%) Post 1994 (26%)

Not the best current clinical practice

Lancet 2001

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SLIDE 4

4

Kastrup, Stroke 2003

Interv Cardiovasc Catheter 2000 Interv Cardiovasc Catheter 2000

STROKE & DEATH

Embolic Protection Device EPD

Kastrup, Stroke 2003

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SLIDE 5

5

Kastrup, Stroke 2003

= 3.7% = 0.5% = 1.1% = 0.3% = 0.8% = 0.8% = 5.5% = 1.1%

Embolic protection methods

Carotid WallStent FilterWire EX/EZ Interv Cardiovasc Catheter 2006 Heart 2003

Literature Review

  • Leicester
  • Wall stent
  • Kentucky
  • CAVATAS
  • Non-randomized

case series

  • SAPPHIRE
  • Non-randomized

case series

  • CREST
  • ICSS
  • EVA – 3s
  • SPACE

BEFORE EPD AFTER EPD

On – going TRIALS

ALKK CAS registry hospitals

  • 28 centres
  • 7/1996-5/2004
  • 1888 pts

Z Cardiol 2005 Z Cardiol 2005

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SLIDE 6

6

Death/Stroke rate (%)

6,3 5,6 7,6 4,9 2,9 3,2 2 4,7 1,9

1 2 3 4 5 6 7 8 9 10 1996 1997 1998 1999 2000 2001 2002 2003 2004

Z Cardiol 2005

« Embolic protection should be considered the standard of care in carotid stenting. When use of an EPD is precluded by anatomic factors, alternative treatment strategies (CEA or medical therapy) must be strongly considered »

Roubin, Circulation 2006

Short-Term Impact of EPDs CAROTID ARTERY STENTING

Feasibility Simplicity Distal protection Results / indications ?

WHAT ARE THE RESULTS ?

CAS vs CEA

WHAT ARE THE RESULTS ?

CAS vs CEA

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SLIDE 7

7

Endarterectomy Kit Surgeon

GUIDELINES for CEA

< 60 % OR RISK > 5 % No CABG < 29 % OR RISK > 6 %

UNACCEPTABLE

> 60 % RISK < 3 % Planned CABG 50 -69 % RISK < 3 %

ACCEPTABLE

> 60 % RISK < 3 % Life expectancy > 5 y 70 -99 % RISK < 6 %

PROVEN

ASYMPTOMATIC SYMPTOMATIC

INDICATION LEVEL

Stroke Council, AHA, Stroke 1998

CAS vs CEA

RESULTS IN SUBGROUPS

  • SYMPTOMATIC PATIENTS
  • ASYMPTOMATIC PATIENTS
  • MODERATE CAROTID STENOSIS
  • SEVERE CAROTID STENOSIS
  • HIGH SURGICAL RISK

SAPPHIRE 2002, USA

NEJM 2004

  • 747 pts
  • ∑ > 50% stenosis,
  • a∑ > 80% stenosis
  • F/U 1,12 mo
  • Stroke/Death/MI D30
  • HIGH SURGICAL RISK

Criteria for high risk

  • Age >80 yr
  • Clinically significant cardiac

disease

–(CHF, abnormal stress test, or need for CABG)

  • Severe COPD

NEJM 2004

Criteria for high risk

  • Contralateral carotid occlusion
  • Previous radical neck surgery or

radiation therapy to the neck

  • Recurrent stenosis after

endarterectomy

  • High lesions behind the mandible
  • Low lesions requiring thoracic

exposure

NEJM 2004

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SLIDE 8

8

SAPPHIRE 2002, USA

747 pts

Endovascular 20/167 Surgery 32/167

406 Excluded Not suitable for stenting

=

High Surgical Risk NEJM 2004

CAS = 87.8% CEA = 79.9%

SAPPHIRE 2002, USA

NEJM 2004

CAS vs CEA

RESULTS IN SUBGROUPS

  • SYMPTOMATIC PATIENTS
  • ASYMPTOMATIC PATIENTS
  • HIGH SURGICAL RISK
  • MODERATE CAROTID STENOSIS
  • SEVERE CAROTID STENOSIS

CAS vs CEA

RESULTS IN SUBGROUPS

  • SYMPTOMATIC PATIENTS
  • ASYMPTOMATIC PATIENTS
  • HIGH SURGICAL RISK
  • MODERATE CAROTID STENOSIS
  • SEVERE CAROTID STENOSIS

?

CREST 2004, USA

2500 patients, ∑ >50% F/U 1 mo Stroke/Death/MI D30

Endovacular + Cerebral protection Surgery Recruitement 2000 454 randomized pts

JVS 2004

EVA-3S 2004, France

1000 pts, ∑ F/U 1,24-48 mo Stroke/Death/Restenosis

Endovacular Surgery Recruitement 2000 452 randomized pts

A R R E T E R P O U R E X C E S D E M O R B I D I T E ! ! ! ! ( M a d a m e l e P r

  • f

e s s e u r M G B

  • u

s s e r ) Clopidogrel/ Ticlopidine

Stroke 2004

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SLIDE 9

9

ICSS 2004 (= CAVATAS-2), UK

1500 pts, ∑ >70% F/U 1 mo Stroke/Death/MI D30

Endovacular ± CP Surgery Recruitement 2001 > 600 so far

Cerebrovasc Dis 2004

SPACE 2001, Germany

1900 pts, ∑ >70% F/U 1 mo Stroke/Death D30 Restenosis 24 mo

Endovacular ± CP Surgery Recruitement 2002 970 pts

Cerebrovasc Dis 2004

Literature Review

  • Leicester
  • Wall stent
  • Kentucky
  • CAVATAS
  • Non-randomized

case series

  • SAPPHIRE
  • Non-randomized

case series

  • CREST
  • ICSS
  • EVA – 3s
  • SPACE

BEFORE EPD AFTER EPD

On – going TRIALS

Je n’ai plus de Données! Nous sommes perdus!!!

  • 1. Available data (one trial) show

that CAS is superior to CEA in selected high risk patients.

  • 2. In all other patient groups no

data is currently available to answer this question

CAS or CEA

Carotid Revascularization Indicated

CEA Risk CAS CEA CEA vs CAS Trial

High Low

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SLIDE 10

10

Carotid Revascularization Indicated

CEA Risk CAS CEA CEA vs CAS Trial

Yes High Low

?

  • Intolerance to antiplatelet agents.
  • Major surgery within 3 to 4 weeks that will

require cessation of antiplatelet therapy

  • Contrast nephropathy (< 75 mL of contrast)
  • Intracranial arterial stenoses
  • arteriovenous malformations
  • Stable aneurysms

CAS: Contradications

Relative

Roubin, Circulation 2006

  • Specific angiographic findings

– excessive tortuosity – massive calcifications circumrferencial –Thrombus burden

CAS: Contradications

Roubin, Circulation 2006

Increased Procedural Risks After CAS

Concentric, circumferential, Width 3 mm Heavy calcification 2 90o bends within 5 cm of the lesion Excessive tortuosity Angiographic Dementia Prior (remote) stroke Multiple lacunar infarcts Intracranial microangiopathy Decreased Cerebral reserve Age > 80 y Advanced age Clinical Features Risk Factor

Impact of age on risk of stroke and death D30

CREST lead-in phase

Age & risk of Stroke / Death

8.14 (1.78-37.30 12 (12.1%) 99 80+ 3.31 (0.75-14.63) 16 (5.3%) 301 70-79 0.78 (0.13-4.75) 3 (1.3%) 229 60-69 1.0 2 (1.7%) 120 <60 OR (95% CI) Events (%) N Age strata

CREST lead-in phase, JVS 2004

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SLIDE 11

11 Increased Procedural Risks After CAS

Concentric, circumferential, Width 3 mm Heavy calcification 2 90o bends within 5 cm of the lesion Excessive tortuosity Angiographic Dementia Prior (remote) stroke Multiple lacunar infarcts Intracranial microangiopathy Decreased Cerebral reserve Age > 80 y Advanced age Clinical Features Risk Factor

Excessive tortuosity

  • Difficulty of access
  • Failure of device delivery
  • Prevent EPD positioning
  • Unsufficient “landing zone”
  • Atheroembolism
  • Air embolism
  • Excessive contrast
  • Bifurcation plaque disruption
  • ICA dissection

Before After

Increased Procedural Risks After CAS

Concentric, circumferential, Width 3 mm Heavy calcification 2 90o bends within 5 cm of the lesion Excessive tortuosity Angiographic Dementia Prior (remote) stroke Multiple lacunar infarcts Intracranial microangiopathy Decreased Cerebral reserve Age > 80 y Advanced age Clinical Features Risk Factor

Plaque Calcifications

Difficulty in

  • Tracking devices
  • Lesion dilation
  • Stent positioning
  • Achieving adequate

expansion

Carotid Revascularization CEA Risk Consider CAS CEA CEA vs CAS Trial Low Risk for CAS

CEA or Medical Therapy

CAS

High Low High Low

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SLIDE 12

12

Pourriez– vous répéter votre topo SVP Car je ne faisais pas attention

Angiographic Restenosis

Gray, STROKE 2002

RESTENOSIS

  • 2167 pts CAS (stenting rate 95%)
  • 5-year follow-up
  • 85% of pts alive & free from ipsilateral

stroke

  • Restenosis rate 4%.

Bosier, J Cardiovasc Surg (Torino) 2005