STENT EM CARÓTIDAS revisão de literatura

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STENT EM CARÓTIDAS revisão de literatura

  1. 1. Carotid StentingCarotid Stenting ReviewReview Renan Uflacker, MD Interventional Radiology Medical University of South Carolina
  2. 2. Carotid StentCarotid Stent IMPORTANCEIMPORTANCE OFOF CAROTID ARTERYCAROTID ARTERY DISEASEDISEASE TREATMENTTREATMENT
  3. 3. Stroke:Stroke:  33rdrd cause of death in UScause of death in US  500,000 cases/year500,000 cases/year  2 milion/year handicaped2 milion/year handicaped peoplepeople HIGH SOCIAL / ECONOMICHIGH SOCIAL / ECONOMIC COSTCOSTMellière et al. J Mal Vasc, 1993 Carotid StentCarotid Stent
  4. 4. Carotid StentCarotid Stent  20 - 30% of VCA are20 - 30% of VCA are related to carotidrelated to carotid occlusive diseaseocclusive disease  Increased incidence withIncreased incidence with age (33% < 45 yrs andage (33% < 45 yrs and 80% >50 yrs)80% >50 yrs) De Bakey et al. J Endovasc Surg, 1996
  5. 5. Carotid StentCarotid Stent  Stenoses > 75%Stenoses > 75% risk of stroke in 1risk of stroke in 1stst yr =yr = 2-5%2-5% Roederer eRoederer et al.t al. Stroke, 1984Stroke, 1984 Hennereci eHennereci et al.t al. Brain, 1987Brain, 1987  Ulceration = Iminent strokeUlceration = Iminent stroke risk of stroke =risk of stroke = 7,5%7,5% AutretAutret et al.et al. Lancet, 1987Lancet, 1987
  6. 6. Carotid StentCarotid Stent  Carotid stenosis + TIACarotid stenosis + TIA  Risk of stroke in 1Risk of stroke in 1stst yr =yr = 12-13%12-13% 55thth yr =yr = 30-30- 37%37% SundtSundt et alet al., 1987., 1987 DennisDennis et al.et al. Stroke, 1990Stroke, 1990  CVA - risk in 1CVA - risk in 1stst yr =yr = 59%59% 55thth yr =yr = 25-45%25-45% SaccoSacco et al.et al. Stroke, 1982Stroke, 1982 MeissnerMeissner et al.et al. Stroke, 1988Stroke, 1988
  7. 7. Carotid StentCarotid Stent  Heterogeneous and ulceratedHeterogeneous and ulcerated lesions = Risklesions = Risk 2-4 x2-4 x LangsfeldLangsfeld et al.et al. J Vasc Surg,J Vasc Surg, 19891989 SterpettiSterpetti et al.et al. Stroke,Stroke, 19881988
  8. 8. Carotid StentCarotid Stent SURGICAL TREATMENT
  9. 9. Carotid StentCarotid Stent ENDARTERECTOMY (1953)ENDARTERECTOMY (1953) – risk of stroke –TIA = 1-2% / Yr –CVA = 2-3% / Yr
  10. 10. Carotid StentCarotid Stent  Clinical Trials such as NASCET/ACASClinical Trials such as NASCET/ACAS established the patern of eficacy ofestablished the patern of eficacy of surgical treatment in comparison tosurgical treatment in comparison to clinical treatmentclinical treatment  Demonstrated the superiority of theDemonstrated the superiority of the method with defined statistical criteriamethod with defined statistical criteria  Surgery is the ¨gold standard¨ for lowSurgery is the ¨gold standard¨ for low risk pacientsrisk pacients
  11. 11. 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)
  12. 12. 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 months Benefits for lesions > 50%
  13. 13. 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% pp << 0,0010,001  Risk CVA/peri-operatory deathsRisk CVA/peri-operatory deaths ==7,57,5 %% ECST (European Carotid Surgery Trials) Lancet 1991;337:1235
  14. 14. Carotid StentCarotid Stent  1662 asymptomatic patients / 5 yrs1662 asymptomatic patients / 5 yrs  stenoses > 60%stenoses > 60%  Risks of CVARisks of CVA Clinical treatmentClinical 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)
  15. 15. Carotid StentCarotid Stent AHA Quality StandardsAHA Quality Standards Surgical TreatmentSurgical Treatment CVA / DeathCVA / Death  Symptomatic PatientsSymptomatic Patients < 6%< 6%  Asymptomatic PatientsAsymptomatic Patients < 3%< 3%
  16. 16. Carotid StentCarotid Stent NASCET (North American Syntomatic CarotidNASCET (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
  17. 17. Carotid StentCarotid Stent  age > 79 anosage > 79 anos  co-morbidity (cardiac/renal/hepatic/ca)co-morbidity (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
  18. 18. Carotid StentCarotid Stent  Death incidence in patients treated with surgeryDeath incidence in patients treated with surgery followed by Medicare is higher in institutionsfollowed by Medicare is higher in institutions participating in the NASCET/ACASparticipating 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 characteristics Wennberg DE, Lucas FL, Birkmeyer JD et al. JAMA 1998;279:1278
  19. 19. Carotid StentCarotid Stent  Patients with high risk of strokePatients with high risk of stroke present also with high risk for surgicalpresent also with high risk for surgical treatmenttreatment Brown et al. J Vasc Surg, 2003; 37:32 Gasparis et al. J Vasc Surg 2003; 37:40 High risk patients Endovascular Treatment
  20. 20. Carotid StentCarotid Stent ENDOVASCULARENDOVASCULAR TREATMENTTREATMENT
  21. 21. Carotid StentCarotid Stent  Carotid angioplasty isCarotid angioplasty is performed with incidence ofperformed with incidence of CVA/deathCVA/death rangingranging 5,3-8,2%.5,3-8,2%. DiethrichDiethrich et al.et al. J Endovasc Surg,1996J Endovasc Surg,1996 BergeronBergeron et al.et al. Cardiovasc Surg,1996Cardiovasc Surg,1996 YadavYadav et al.et al. Circulation,1997Circulation,1997 HenryHenry et al.et al. J Endovasc Surg,1997J Endovasc Surg,1997
  22. 22. 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 111111 8,8%8,8%  92/9492/94 196196 4,8%4,8%  95/9995/99 617617 2,0%2,0% K. Matias ISES Jan 2000
  23. 23. 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:
  24. 24. Carotid StentCarotid Stent Antiplatelet therapy, before and after theAntiplatelet therapy, before and after the procedureprocedure ↓ Acute thrombosis of the stent ↓ Embolism Vitek et al. AJNR 2000
  25. 25. Carotid StentCarotid Stent WALLSTENT TRIALWALLSTENT TRIAL  219 patients219 patients  No protectionNo protection  No antiplatelet therapyNo antiplatelet therapy Surgical 4,5% Endovascular 12,1%Risk CVA/death Trial was interrupted Stroke 2001;32:325
  26. 26. Carotid StentCarotid Stent What to do with the plaque fragments
  27. 27. Carotid StentCarotid Stent Cerebral Protection
  28. 28. 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
  29. 29. 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.
  30. 30.  Embolic event is related to:Embolic event is related to: - Guidewire placement- Guidewire placement - Passage through the lesion- Passage through the lesion - Dilation of the estenoses- Dilation of the estenoses - Stent placement- Stent placement - Stent dilation (self or balloon- Stent dilation (self or balloon expandable)expandable) Carotid StentCarotid Stent
  31. 31. J.Theron’s Technique Theron el al. AJNR, 1990 Carotid StentCarotid Stent
  32. 32. Carotid StentCarotid Stent
  33. 33. Carotid StentCarotid Stent
  34. 34. Carotid StentCarotid Stent
  35. 35. E.P.I. Carotid StentCarotid Stent
  36. 36. Carotid StentCarotid Stent
  37. 37. Carotid StentCarotid Stent
  38. 38. Carotid StentCarotid Stent
  39. 39. 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
  40. 40. Carotid StentCarotid Stent  Non contributing factors:Non contributing factors: - Gender- Gender - Neurologic symptoms- Neurologic symptoms - Coronary disease- Coronary disease - Diabetes,- Diabetes,↑↑ cholesterol, tabaco usecholesterol, tabaco use - Bilateral lesion- Bilateral lesion - Contralateral occlusion- Contralateral occlusion Matur et al. Circulation, 1998
  41. 41. Carotid StentCarotid Stent Clinical experience:Clinical experience:  Jacques TheronJacques Theron CVA/death =CVA/death = 2%2% Theron J.Theron J. et alet al AJNR 1990;11:869AJNR 1990;11:869  75 patients75 patients CVA/death =CVA/death = 00 Whintlow P. CAFE study 2000Whintlow P. CAFE study 2000  167 patients167 patients CVA/death =CVA/death = 2,7%2,7% Henry M.Henry M. et alet al J Endovasc T 2002;9:1J Endovasc T 2002;9:1
  42. 42. 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
  43. 43. Carotid StentCarotid Stent Early outcome of carotid angioplasty andEarly outcome of carotid angioplasty and stenting with and without cerebralstenting with and without cerebral protection devices. Review of literatureprotection devices. Review of literature Kastrup A, Groschel K, Kraft HKastrup A, Groschel K, Kraft H et al.et al. PTA NO/ PROTECTION 5,5% 3,7% 1,1% 0,8% PTA WITH/ PROTECTION 1,8% 0,5% 0,3% 0,8% GLOBAL cva minor cva major death P < 0.001 P < 0.001 P < 0.05 P = 0.6 Stroke 2003;34:813
  44. 44. Carotid StentCarotid Stent CAVATASCAVATAS  Endovascular versus surgical treatment inEndovascular versus surgical treatment in patients with carotid stenosis in thepatients with carotid stenosis in the CCarotidarotid andand VVertebralertebral AArteryrtery TTransluminalransluminal AAngioplastyngioplasty SStudy (CAVATAS): Atudy (CAVATAS): A randomized trial.randomized trial. Lancet. 2001;357:1729-1737.
  45. 45. Carotid StentCarotid Stent CAVATASCAVATAS  506 patients506 patients  22 centers / 3 years22 centers / 3 years  Intervencionalists with smallIntervencionalists 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.
  46. 46. Carotid StentCarotid Stent CAVATAS - RESULTSCAVATAS - RESULTS PTAPTA SurgicalSurgical  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 nerveCranial nerve 00 8,7%8,7%  Restenosis (1yr)Restenosis (1yr) 14%14% 4%4%  No statistical differences in stroke riskNo statistical differences in stroke risk between the two groups after 3 years.between the two groups after 3 years.Lancet. 2001;357:1729-1737.
  47. 47. Carotid StentCarotid Stent SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy)  334 patients symptomatic or not with high334 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
  48. 48. 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
  49. 49. Carotid StentCarotid Stent SAPPHIRE (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 %
  50. 50. 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
  51. 51. Carotid StentCarotid Stent  ARCHeR 1 – Carotid StentARCHeR 1 – Carotid Stent – 158 patients158 patients  ARCHeR 2 – Stent + EmbolicARCHeR 2 – Stent + Embolic ProtectionProtection – 278 patients278 patients  ARCHeR 3 – Newer version RapidARCHeR 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
  52. 52. ARCHeR Trial – 581 combined patients 30 days combined end points
  53. 53. ARCHeR 1ARCHeR 1
  54. 54. ARCHeR 2ARCHeR 2
  55. 55. Carotid StentCarotid Stent TRIALS E REGISTERS
  56. 56.  CRESTCREST – 2.500 Symptomatic patiens with low2.500 Symptomatic patiens with low risk / 5 yearsrisk / 5 years – Randomized; 60 centersRandomized; 60 centers – Cerebral ProtectionCerebral Protection – Sponsored by NIH / GuidantSponsored by NIH / Guidant Carotid StentCarotid Stent
  57. 57. Carotid StentCarotid Stent  CARESSCARESS(Carotid Revascularization Using(Carotid Revascularization Using Endarterectomy or Stenting Systems)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, MI30-day all-cause mortality, stroke, MI  CEA 3%CEA 3%  CSS 2% (with protection)CSS 2% (with protection)
  58. 58. Carotid StentCarotid Stent  Surgical treatment is still theSurgical treatment is still the “gold standard” for low risk“gold standard” for low risk patientspatients  More recent studies withMore recent studies with cerebral protection devices arecerebral protection devices are rapidly changing this concept.rapidly changing this concept.
  59. 59. Carotid StentCarotid Stent  In 2002 only 4% of carotid stenosisIn 2002 only 4% of carotid stenosis were treated by PTA and stentswere treated by PTA and stents  Projections for year 2006 anticipateProjections for year 2006 anticipate it will be 75% of all cases of carotidit will be 75% of all cases of carotid stenosis due to approval of thestenosis due to approval of the procedure/devices by the FDA inprocedure/devices by the FDA in light of the clinical studieslight of the clinical studies Morgan & Stanley 2003
  60. 60. 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
  61. 61. Carotid StentCarotid Stent

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