Download - 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
Carotid StentCarotid Stent
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
SURGICALTREATMENT
Carotid StentCarotid Stent
ENDARTERECTOMY (1953)ENDARTERECTOMY (1953)
– risk of stroke
–TIA = 1-2% / Yr
–CVA = 2-3% / Yr
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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)
Carotid StentCarotid Stent
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%
Carotid StentCarotid Stent
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%
Surgical treatment = Surgical treatment = 2,8%2,8%
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
Carotid StentCarotid Stent
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%
Surgical treatment = Surgical treatment = 4,8%4,8%
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)
Carotid StentCarotid Stent
AHA Quality StandardsAHA Quality Standards
Surgical TreatmentSurgical Treatment
CVA / DeathCVA / Death Symptomatic Patients Symptomatic Patients < 6%< 6% Asymptomatic Patients Asymptomatic Patients < 3%< 3%
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
ENDOVASCULARENDOVASCULARTREATMENTTREATMENT
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
0
1
2
3
4
5
6
7
8
9
94 95 96 97 98
Vitek et al. AJNR 2000
Incidence of complications:
Carotid StentCarotid Stent
Antiplatelet therapy, before and Antiplatelet therapy, before and after the procedureafter the procedure
Acute thrombosis of the stent Embolism
Vitek et al. AJNR 2000
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
What to do with the plaquefragments
Carotid StentCarotid Stent
Cerebral Protection
Carotid StentCarotid Stent
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 StentCarotid Stent
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)
Carotid StentCarotid Stent
J.Theron’s Technique
Theron el al. AJNR, 1990
Carotid StentCarotid Stent
Carotid StentCarotid Stent
Carotid StentCarotid Stent
Carotid StentCarotid Stent
E.P.I.
Carotid StentCarotid Stent
Carotid StentCarotid Stent
Carotid StentCarotid Stent
Carotid StentCarotid Stent
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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.
Carotid StentCarotid Stent
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.
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
SAPPHIRE (Stenting and Angioplasty with Protection
in Patients at High Risk for Endarterectomy)
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
in Patients at High Risk for Endarterectomy)
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 %
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
Carotid StentCarotid Stent
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)
Carotid StentCarotid Stent
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.
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent
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
Carotid StentCarotid Stent