Management of Carotid Artery Stenosis - Evidence and guidelines
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Current Management of Carotid artery stenosis. Comparison of Endarterectomy vs. Stenting. Evidence review. Discussion of present guidelines.
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Management of Carotid Artery Stenosis - Evidence and guidelines
- 1. CAROTID STENOSIS MANAGEMENT Satyam Rajvanshi Endarterectomy Stenting vs.
- 2. INTRODUCTION
- 3. STROKE • 2nd leading cause of death worldwide (after CAD) • Majority of strokes (∼90%) are ischemic in nature • Of these, 15% to 20% are attributed to carotid artery stenosis Primary prevention of ischemic stroke: a guideline from AHA/ASA Circulation 2006;113:e873–923 WHO data: 2015
- 4. Ischemic Stroke – Causes? CAUSE DICTATES MANAGEMENT LARGE VESSEL ATHEROEMBOLISM (most common) • Artery to artery embolism • Thrombosis in situ SMALL VESSEL ATHEROEMBOLISM • Lacunar disease associated with hypertension and diabetes LOW-FLOW STATE • Ischemic “watershed” areas CARDIOEMBOLISM • Nonvalvular AF • Post-MI • Dilated cardiomyopathy • Prosthetic heart valves • Rheumatic heart disease • Infective endocarditis • Patent foramen ovale
- 5. Ischemic Stroke – Causes? CAUSE DICTATES MANAGEMENT LARGE VESSEL ATHEROEMBOLISM (most common) • Artery to artery embolism • Thrombosis in situ SMALL VESSEL ATHEROEMBOLISM • Lacunar disease associated with hypertension and diabetes LOW-FLOW STATE • Ischemic “watershed” areas CARDIOEMBOLISM • Nonvalvular AF • Post-MI • Dilated cardiomyopathy • Prosthetic heart valves • Rheumatic heart disease • Infective endocarditis • Patent foramen ovale
- 6. WHY TACKLE THE CAROTID LESION MECHANICALLY?
- 7. It’s the natural history! • ~ 30% of stroke survivors die within the first 12 months and two-thirds die within the next 12 years • One ischemic stroke incidence of a 2nd stroke within 5 years of ~ 40% to 50% Primary prevention of ischemic stroke: a guideline from AHA/ASA Circulation 2006;113:e873–923
- 8. It’s the natural history! • Stroke risk in Carotid artery stenosis – Carotid symptoms? – Severity of stenosis? – Others - Plaque composition? Plaque ulceration? Circulation 2006;113:e873–923 NEJM 1998;339:1415-25
- 9. It’s the natural history! • TIA secondary to significant carotid artery stenosis ~ 30-40% risk of stroke within the next 5 years • In symptomatic patients, 2-year risk – 22% with 50%-69% (moderate) stenosis vs. 26% in 70% - 99% (severe) stenosis Circulation 2006;113:e873–923 NEJM 1998;339:1415-25
- 10. It’s the natural history! • In asymptomatic patients, 5-year risk – 7.8% with <50% stenosis vs. 18.5% in 75% - 95% stenosis Circulation 2006;113:e873–923
- 11. Low medical treatment efficacy! • Relative risk reduction with medical treatment is no more than 25% • CEA provides better protection against future events – proven in RCTs Primary prevention of ischemic stroke: a guideline from AHA/ASA Circulation 2006;113:e873–923
- 12. CEA/BMT vs. BMT alone
- 13. Silent disease burden and stroke risk? • Estimated incidence of asymptomatic extracranial carotid stenosis in >65 year olds >50% stenosis – 5 to 10% >80% (Critical) – less than 1% • Annual risk of stroke in asymptomatic >50% stenosis – from <1% to 4.3% • But 80% stroke occur without recognizable warning symptoms! Circulation 2006;113:e873–923 JACC 2014;64:722-31
- 14. HISTORY IN BRIEF
- 15. Carotid Endarterectomy (CEA) • 1920s - Introduction of cerebral angiography. Carotid artery disease was found among persons with stroke • 1950s - C.M. Fisher called attention to atherosclerosis involving the carotid bifurcation as an important cause of stroke and suggested surgery as a possible therapy • 1954 - De Bakey performed the 1st carotid endarterectomy
- 16. Carotid Angioplasty • 1980 - 1st POBA by Kerber 2 major complications • Acute closure • Distal embolization • 1996 – CAS Roubin et al Tackled acute closure • 1996 – CAS + EPD Theron et al To distal embolization • Patient & lesion selection • Meticulous technique • Embolic protection devices Am J Neuroradiol 1980;1:348-9 Am J Cardiol 1996;78:8-12 Radiology 1996;201:627-36
- 17. Carotid Angioplasty • 1980 - 1st POBA by Kerber 2 major complications • Acute closure • Distal embolization • 1996 – CAS Roubin et al Tackled acute closure • 1996 – CAS + EPD Theron et al To distal embolization • Patient & lesion selection • Meticulous technique • Embolic protection devices Palliation in the inoperable ? Equivalence to Surgery ? Superiority to Surgery Am J Neuroradiol 1980;1:348-9 Am J Cardiol 1996;78:8-12 Radiology 1996;201:627-36
- 18. AND THEN STARTED THE DEBATE…
- 19. CEA vs CAS Where do we stand?
- 20. HIGH SURGICAL RISK ± SYMPTOMS
- 22. SAPPHIRE • RCT: 167 pts each in CEA vs CAS group
- 23. SAPPHIRE • CAS (Self expanding nitinol stent – Smart or Precise) with EPD (Filter basket – Angioguard)
- 24. SAPPHIRE Primary end point of the study - cumulative incidence of a major cardiovascular event at 1 year — a composite of death, stroke, or myocardial infarction within 30 days after the intervention or death or ipsilateral stroke between 31 days and 1 year P=0.053
- 25. SAPPHIRE 3 yr NEJM 2008;358:1572-9
- 26. SAPPHIRE 3 yr Prespecified major end point, defined as death, myocardial infarction, or stroke within 30 days or death or ipsilateral stroke between 31 days and 1080 days
- 27. SYMPTOMATIC + AVERAGE SURGICAL RISK
- 29. SPACE • 1214 pts • Symptomatic severe stenosis (>70% ECST or >50% NASCET) • CAS by inexperienced operators • EPD not necessary – used in 27% only • Stopped early due to futility
- 30. SPACE • Freedom from primary outcome – difference larger than non- inferiority margin
- 31. SPACE 2 yr Lancet 2008;7:893-902
- 32. SPACE 2 yr • CAS noninferior to CEA at 2 years!
- 34. EVA-3S • 527 pts • Symptomatic severe stenosis (>60% NASCET) • CAS by inexperienced operators – only required to perform 2 CAS before being eligible • Surgeons were relatively experienced – atleast 25 CEA before being eligible! • EPD used in 91% only – not in all because not mandatory in 1st 2 yrs • Stopped early due to futility
- 35. EVA-3S • CAS had RR of 2.5 vs CEA for any stroke/death at 30 days!
- 36. EVA-3S 4 yr Lancet Neurol 2008;7:885-92
- 38. ICSS • 1713 pts • Symptomatic severe stenosis (>50% NASCET) • CAS by operators with atleast 10 CAS experience • CEA by operators with atleast 50 CEA experience! • EPD used in 72% only
- 39. ICSS
- 40. ICSS 5 yr Lancet 2015;385:529-38
- 41. ICSS 5 yr Fatal or disabling stroke Periprocedural stroke or Periprocedural death Any stroke All cause death
- 43. CREST • 2502 pts • Symptomatic stenosis (>50% ECST; >70% on USG; >70% on CT/MRI if 50-69% on USG) – 1321 pts • Asymptomatic stenosis (>60% ECST ; >70% on USG; >80% on CT/MRI if 50-69% on USG) – 1181 pts • Standard stroke detection protocol in follow-up • EPD use mandatory whenever feasible – used in 96.1%
- 44. CREST Primary end point - composite of stroke, MI, or death from any cause during the periprocedural period or ipsilateral stroke within 4 years after randomization
- 45. CREST 10 yr NEJM 2016;374:1021-31
- 46. CREST 10 yr No difference in primary end-point Only periprocedural strokes more in CAS – that too minor strokes
- 47. CREST 10 yr Restenosis - >70% on USG on routine annual follow-up exam No difference - 12.2% in CAS vs 9.6% in CEA
- 48. CREST 10 yr
- 49. JACC 2011 – Non RCT real world trial
- 50. ASYMPTOMATIC + AVERAGE SURGICAL RISK
- 52. ACT 1 • 1453 pts • Stopped early due to slow enrollment • Asymptomatic severe stenosis – free from ipsilateral TIA/stroke in last 6 months (>70% ECST or >70% on USG; without >60% contralateral stenosis) • CAS by experienced operators • Closed cell tapered nitinol stent (Xact stent) with Distal EPD (Emboshield) - used in 97.8%
- 53. ACT 1 Freedom from death, stroke, and MI within 30 days and from ipsilateral stroke within 365 days after the procedure in ITT population
- 54. CEA vs CAS vs BMT
- 55. CEA vs CAS vs BMT RCT ongoing • CREST 2 – Asymptomatic pts at average surgical risk • ECST 2 – Asymptomatic and Low risk symptomatic pts
- 56. Overall comparison CEA vs CAS Characteristics CEA CAS General anesthesia requirement/complication ↑↑ ↓ Periprocedural MI ↑↑ ↓ Periprocedural minor stroke ↓ ↑ Periprocedural major stroke = = Cranial nerve damage ↑↑ ↓ Longer recovery ↑ ↓ Wound complication ↑ ↓
- 57. GUIDE TO CHOOSE ONE OVER OTHER
- 58. Best strategy? • Patient factors – Age, comorbidities, life expectancy, functional status, patient preference • Disease factors – Risk of stroke, anatomy, resources
- 59. • Based on review of 192 papers on carotid stenosis management • 1 point to each favourable character; 3 points to each absolute character • Higher number of points indicate that strategy has better evidence • Equal points – patient preference!
- 61. GUIDELINES
- 72. CONCLUSIONS
- 73. CONCLUSIONS • CAS has probably achieved a clinical equipoise with CEA • Operator experience is key to successful and efficient CAS • RCT with BMT arm are needed in asymptomatic pts and are ongoing • Individualized management strategy is the answer to this problem – no place for ‘one size fits all’
- 76. CREST
- 77. ACT 1