stent em carÓtidas revisão de literatura

Carotid Carotid StentingStenting ReviewReview

Renan Uflacker, MDInterventional RadiologyMedical University of South Carolina

Carotid StentCarotid Stent

IMPORTANCE IMPORTANCE OFOF

CAROTID ARTERY CAROTID ARTERY DISEASE DISEASE

TREATMENTTREATMENT

Stroke:Stroke: 33rdrd cause of death in US cause of death in US 500,000 cases/year500,000 cases/year 2 milion/year handicaped people2 milion/year handicaped people

HIGH SOCIAL / ECONOMIC COSTHIGH SOCIAL / ECONOMIC COST

Mellière et al. J Mal Vasc, 1993



20 - 30% of VCA are 20 - 30% of VCA are related to carotid related to carotid occlusive diseaseocclusive disease

Increased incidence with Increased incidence with age (33% < 45 yrs and age (33% < 45 yrs and 80% >50 yrs)80% >50 yrs)

De Bakey et al. J Endovasc Surg, 1996


Stenoses > 75%Stenoses > 75%risk of stroke in 1risk of stroke in 1stst yr = yr = 2-2-

5%5% Roederer eRoederer et al.t al. Stroke, 1984 Stroke, 1984

Hennereci eHennereci et al.t al. Brain, 1987 Brain, 1987

Ulceration = Iminent stroke Ulceration = Iminent stroke risk of stroke = risk of stroke = 7,5%7,5%

Autret Autret et al.et al. Lancet, 1987 Lancet, 1987

Carotid StentCarotid Stent Carotid stenosis + TIA Carotid stenosis + TIA Risk of stroke in 1Risk of stroke in 1stst yr = yr = 12-13%12-13%

5 5thth yr = yr = 30-30-37%37%

Sundt Sundt et alet al., 1987., 1987 Dennis Dennis et al.et al. Stroke, 1990 Stroke, 1990

CVA - risk in 1CVA - risk in 1stst yr = yr = 59%59%

55thth yr = yr = 25-45%25-45% Sacco Sacco et al.et al. Stroke, 1982 Stroke, 1982

Meissner Meissner et al.et al. Stroke, Stroke, 19881988


Heterogeneous and ulcerated Heterogeneous and ulcerated lesions = Risk lesions = Risk 2-4 x2-4 x

Langsfeld Langsfeld et al.et al. J Vasc Surg, J Vasc Surg, 19891989

Sterpetti Sterpetti et al.et al. Stroke, Stroke, 1988 1988


SURGICALTREATMENT


ENDARTERECTOMY (1953)ENDARTERECTOMY (1953)

– risk of stroke

–TIA = 1-2% / Yr

–CVA = 2-3% / Yr


Clinical Trials such as NASCET/ACAS Clinical Trials such as NASCET/ACAS established the patern of eficacy of established the patern of eficacy of surgical treatment in comparison to surgical treatment in comparison to clinical treatmentclinical treatment

Demonstrated the superiority of the Demonstrated the superiority of the method with defined statistical method with defined statistical criteria criteria

Surgery is the ¨gold standard¨ for Surgery is the ¨gold standard¨ for low risk pacientslow risk pacients


559 symptomatic patients / 2 anos559 symptomatic patients / 2 anos Estenoses > 70%Estenoses > 70% Risk of CVARisk of CVA

Clinical treatment = Clinical treatment = 13,1%13,1%

Surgical treatment = Surgical treatment = 2,5%2,5%

PP < 0,001 < 0,001

N Engl J Med 1991;325:445

NASCET (North American Symptomatic Carotid Trial)


NASCET (North American Symptomatic Carotid Trial)NASCET (North American Symptomatic Carotid Trial)

N Engl J Med 1991;325:445

Risk CVA/peri-operatory death = 5,8%Benefits of surgery evident after 3 monthsBenefits for lesions > 50%


778 symptomatic patients / 3 yrs778 symptomatic patients / 3 yrs stenoses > 70%stenoses > 70% Risk of CVARisk of CVA

Clinical treatment = Clinical treatment = 16,8%16,8%


p p < 0,001< 0,001

Risk CVA/peri-operatory deaths =Risk CVA/peri-operatory deaths =7,57,5%%

ECST (European Carotid Surgery Trials)

Lancet 1991;337:1235


1662 asymptomatic patients / 5 yrs1662 asymptomatic patients / 5 yrs stenoses > 60%stenoses > 60% Risks of CVARisks of CVA

Clinical treatment Clinical treatment ==10,6%10,6%


PP < 0,004 < 0,004 Risk CVA/peri-operatory death = Risk CVA/peri-operatory death = 2,32,3%%

Stroke 1994; 25: 2523-2524Stroke 1994; 25: 2523-2524

ACAS (Asymptomatic Carotid Atherosclerosis Study)ACAS (Asymptomatic Carotid Atherosclerosis Study)


AHA Quality StandardsAHA Quality Standards

Surgical TreatmentSurgical Treatment

CVA / DeathCVA / Death Symptomatic Patients Symptomatic Patients < 6%< 6% Asymptomatic Patients Asymptomatic Patients < 3%< 3%


NASCET (North American Syntomatic Carotid NASCET (North American Syntomatic Carotid Trial)Trial)

Cranial Nerve Lesion : 7,6%Hematoma : 5,5%

Extensive list of exclusion criteria !Extensive list of exclusion criteria !

N Engl J Med 1991;325:445


age > 79 anosage > 79 anos co-morbidity co-morbidity

(cardiac/renal/hepatic/ca)(cardiac/renal/hepatic/ca) valvulophaty / arrithmiasvalvulophaty / arrithmias previous endarterectomyprevious endarterectomy unstable angina / recent MIunstable angina / recent MI previous surgery (30 days)previous surgery (30 days)

Exclusion Criteria - NASCET / ACAS


Death incidence in patients treated with Death incidence in patients treated with surgery followed by Medicare is higher in surgery followed by Medicare is higher in institutions participating in the NASCET/ACASinstitutions participating in the NASCET/ACAS

NASCET 0,6%ACAS 0,1%

1,4% MEDICARE

Variation in carotid endarterectomy mortality in the Medicare population: trial hospitals, volume and patient characteristicsWennberg DE, Lucas FL, Birkmeyer JD et al.

JAMA 1998;279:1278


Patients with high risk of stroke Patients with high risk of stroke present also with high risk for present also with high risk for surgical treatmentsurgical treatment

Brown et al. J Vasc Surg, 2003; 37:32Gasparis et al. J Vasc Surg 2003; 37:40

High riskpatients

Endovascular Treatment


ENDOVASCULARENDOVASCULARTREATMENTTREATMENT


Carotid angioplasty is Carotid angioplasty is performed with incidence of performed with incidence of CVA/death CVA/death

ranging ranging 5,3-8,2%.5,3-8,2%.

Diethrich Diethrich et al.et al. J Endovasc Surg,1996 J Endovasc Surg,1996Bergeron Bergeron et al.et al. Cardiovasc Surg,1996 Cardiovasc Surg,1996

Yadav Yadav et al.et al. Circulation,1997 Circulation,1997Henry Henry et al.et al. J Endovasc Surg,1997 J Endovasc Surg,1997


LEARNING CURVE:LEARNING CURVE:CLINICAL EXPERIENCE: 89/99 10 yearsCLINICAL EXPERIENCE: 89/99 10 years

N = 924N = 924 (independent neurologic evaluation)(independent neurologic evaluation)

#Angioplasties #Angioplasties ComplicationsComplications

89/9189/91 111 111 8,8%8,8% 92/9492/94 196 196 4,8%4,8% 95/9995/99 617 617 2,0%2,0%

K. Matias ISES Jan 2000


0

1

2

3

4

5

6

7

8

9

94 95 96 97 98

Vitek et al. AJNR 2000

Incidence of complications:


Antiplatelet therapy, before and Antiplatelet therapy, before and after the procedureafter the procedure

Acute thrombosis of the stent Embolism

Vitek et al. AJNR 2000


WALLSTENT TRIALWALLSTENT TRIAL 219 patients219 patients No protection No protection No antiplatelet therapyNo antiplatelet therapy

Surgical4,5%

Endovascular12,1%Risk CVA/death

Trial was interrupted

Stroke 2001;32:325


What to do with the plaquefragments


Cerebral Protection


There is considerable evidence of

embolization during carotid angioplasty

DeMonte et al. J Neurosurg. 1989;70:138

Ohki, T et al. J Vasc Surg. 1998;27:463


Carotid artery stenting protected with an emboli containment system Whitlow PL, Lylyk P, Londero H, et al.

Visible particles and debrís from plaques, cholesterol and

calcific fragments # 22 to 667 particles with average size

of 200 microns (range 3.6 to 5262) captured with cerebral

protection system (PercuSurge)

Stroke. 2002;33(5):1308-1314.

Embolic event is related to:Embolic event is related to:

- Guidewire placement- Guidewire placement

- Passage through the - Passage through the lesionlesion

- Dilation of the estenoses- Dilation of the estenoses

- Stent placement- Stent placement

- Stent dilation (self or - Stent dilation (self or balloon expandable)balloon expandable)


J.Theron’s Technique

Theron el al. AJNR, 1990


E.P.I.



Risk factors for embolism:Risk factors for embolism:

- Old age ( > 80 anos)- Old age ( > 80 anos)

- Arterial Hypertension- Arterial Hypertension

- Recent stroke- Recent stroke

Al Mubarack et al. A J Cardiol, 1999


Non contributing factors:Non contributing factors:

- Gender- Gender

- Neurologic symptoms- Neurologic symptoms

- Coronary disease- Coronary disease

- Diabetes,- Diabetes, cholesterol, tabaco use cholesterol, tabaco use- Bilateral lesion- Bilateral lesion- Contralateral occlusion- Contralateral occlusion

Matur et al. Circulation, 1998


Clinical experience:Clinical experience: Jacques TheronJacques Theron CVA/death = CVA/death = 2%2%

Theron J.Theron J. et al et al AJNR 1990;11:869 AJNR 1990;11:869

75 patients75 patients CVA/death = CVA/death = 00Whintlow P. CAFE study 2000Whintlow P. CAFE study 2000

167 patients167 patients CVA/death = CVA/death = 2,7%2,7%Henry M.Henry M. et al et al J Endovasc T 2002;9:1 J Endovasc T 2002;9:1


PTA/Stent NO/ cerebral protection (n=1596) 4,2%

PTA/Stent WITH/ cerebral protection (n=771) 1,7%

Global experience in cervical carotid artery stent placement.Wholey M H, Mathias K, et al.

Cathet Cardiovasc Intervent. 2000;50(2):160

CVA/death


Early outcome of carotid angioplasty Early outcome of carotid angioplasty and stenting with and without cerebral and stenting with and without cerebral protection devices. Review of literatureprotection devices. Review of literature

Kastrup A, Groschel K, Kraft H Kastrup A, Groschel K, Kraft H et al.et al.

PTA NO/ PROTECTION5,5%3,7%1,1%0,8%

PTA WITH/ PROTECTION1,8%0,5%0,3%0,8%

GLOBALcva minorcva major

death

P < 0.001P < 0.001P < 0.05P = 0.6

Stroke 2003;34:813


CAVATASCAVATAS

Endovascular versus surgical treatment Endovascular versus surgical treatment

in patients with carotid stenosis in the in patients with carotid stenosis in the

CCarotid and arotid and VVertebral ertebral AArtery rtery

TTransluminal ransluminal AAngioplasty ngioplasty SStudy tudy

(CAVATAS): A randomized trial.(CAVATAS): A randomized trial.Lancet. 2001;357:1729-1737.


CAVATASCAVATAS 506 patients506 patients 22 centers / 3 years22 centers / 3 years Intervencionalists with small Intervencionalists with small

experience in carotid PTA.experience in carotid PTA. Irregular use of stentsIrregular use of stents No cerebralprotectionNo cerebralprotection

Lancet. 2001;357:1729-1737.


CAVATAS - RESULTSCAVATAS - RESULTSPTA SurgicalPTA Surgical

CVA/death (30 days)CVA/death (30 days) 6,4%6,4% 5,9%5,9%

CVA/death (> 7 days)CVA/death (> 7 days) 10%10% 9,9%9,9% Cranial nerve Cranial nerve 0 0 8,7%8,7% Restenosis (1yr)Restenosis (1yr) 14%14% 4% 4% No statistical differences in stroke risk No statistical differences in stroke risk

between the two groups after 3 years. between the two groups after 3 years. Lancet. 2001;357:1729-1737.

Carotid StentCarotid StentSAPPHIRE (Stenting and Angioplasty with Protection

in Patients at High Risk for Endarterectomy)

334 patients symptomatic or not with high 334 patients symptomatic or not with high risk (excluded from NASCET criteria)risk (excluded from NASCET criteria)

RandomizedRandomized Degre stenosesDegre stenoses

Symptomatic > 50%Symptomatic > 50% Asynptomatic > 85%Asynptomatic > 85%

413 patients not randomized (registry)413 patients not randomized (registry) Sponsored by Cordis - angioguard + preciseSponsored by Cordis - angioguard + precise


SAPPHIRE (Stenting and Angioplasty with Protection


PTA/Stent technical success 95,6%

Death, stroke, MI cummulative within 30 days or

between 31 days and 1 year:

PTA/Stent = 12.2%

CEA = 20.1%

Randomized group

P = 0.047

Yadav JS, et al. NEJM OCT 2004

Carotid StentCarotid StentSAPPHIRE (Stenting and Angioplasty with Protection


Stroke, death, MI < 30 days:

PTA/Stent 4.8%

CEA 9.8 %

Stroke, death, MI Symptomatic at 1 yr

PTA/Stent 16.8 %

CEA 16.5 %


Technical Success = 95.9% - 99.3%Technical Success = 95.9% - 99.3% Particles in the filter (debrís) = 57%Particles in the filter (debrís) = 57% CVA/Death = CVA/Death = 6,6%6,6% CVA/Death/MI = CVA/Death/MI = 7,8%7,8% Degree of stenosesDegree of stenoses

– Symptomatic > 50%Symptomatic > 50%– Asymptomatic > 80%Asymptomatic > 80%

ARCHeR TRIAL:

Sponsored by Guidant: Accunet + AcculinkSponsored by Guidant: Accunet + Acculink


ARCHeR 1 – Carotid StentARCHeR 1 – Carotid Stent– 158 patients158 patients

ARCHeR 2 – Stent + Embolic ProtectionARCHeR 2 – Stent + Embolic Protection– 278 patients278 patients

ARCHeR 3 – Newer version Rapid ARCHeR 3 – Newer version Rapid exchange system + Embolic Protectionexchange system + Embolic Protection– 145 patients145 patients

ARCHeR Trial – 581 combined patients

Sponsored by Guidant: Accunet + AcculinkSponsored by Guidant: Accunet + Acculink

ARCHeR Trial – 581 combined patients30 days combined end points

ARCHeR 1ARCHeR 1

ARCHeR 2ARCHeR 2


TRIALS E

REGISTERS

CRESTCREST– 2.500 Symptomatic patiens with 2.500 Symptomatic patiens with

low risk / 5 yearslow risk / 5 years– Randomized; 60 centersRandomized; 60 centers– Cerebral ProtectionCerebral Protection– Sponsored by NIH / GuidantSponsored by NIH / Guidant



CARESSCARESS(Carotid Revascularization (Carotid Revascularization Using Endarterectomy or Stenting Systems)Using Endarterectomy or Stenting Systems)

– 439 patients439 patients– 90% with >75% stenosis90% with >75% stenosis– 68% asymptomatic68% asymptomatic– 30-day mortality and stroke30-day mortality and stroke

CEA 2%CEA 2% CSS 2% (with protection)CSS 2% (with protection)

– 30-day all-cause mortality, stroke, 30-day all-cause mortality, stroke, MIMI

CEA 3%CEA 3% CSS 2% (with protection)CSS 2% (with protection)


Surgical treatment is still the Surgical treatment is still the “gold standard” for low risk “gold standard” for low risk patientspatients

More recent studies with More recent studies with cerebral protection devices cerebral protection devices are rapidly changing this are rapidly changing this concept.concept.


In 2002 only 4% of carotid stenosis In 2002 only 4% of carotid stenosis were treated by PTA and stentswere treated by PTA and stents

Projections for year 2006 anticipate Projections for year 2006 anticipate it will be 75% of all cases of carotid it will be 75% of all cases of carotid stenosis due to approval of the stenosis due to approval of the procedure/devices by the FDA in procedure/devices by the FDA in light of the clinical studieslight of the clinical studies

Morgan & Stanley 2003


Timing and frequency of complications after carotid artery stenting:What is the optimal period of observation?Tan KT, Cleveland TJ, Berczi V, et al.

•Safety criteria for same day discharge of patients•204 patients Incidence of complications = 5,4%

• 52,6% 6 hs• 5,3% 6-12 hs• 7,9% 12-24 hs

J Vasc Surg. 2003;38:236

stent em carÓtidas revisão de literatura

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