WH WONG Queen Mary Hospital
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Is Carotid Stenting an Option for Treatment of Carotid Stenosis?
Joint Hospital Surgical Grand Round
WH WONG Queen Mary Hospital
Carotid stenosis- pathophysiology
Early degenerative plaque formation(cholesterol/ lipids/ inflammatory cells)
⇓ ulceration/ haemorrhage
Flow limiting stenosis
⇙ ⇘Thrombosis Embolism
Spagnoli LG et al., JAMA 2004
Investigation modalities
Carotid duplex ultrasonography
diagnostic study of choice for screening
very accurate predictability for high grade lesion (70% stenosis)
CT/ MRI angiography
useful in collaboration with USG for further characterization of lesion producing >50% stenosis
Cerebral angiography
gold standard for accurate characterization of plaque and collateral circulation
Treatment modalities
Risk factors modification
Best medical therapy
Surgical treatment
Risk factors modification
Hypertension
OR of 2.11 for every 20mmHg increase in systolic pressure
Dyslipidaemia
OR of 1.1 for every 10mg/dL in cholesterol
Diabetes
Smoking
OR of 1.08 for every 5 pack-years of smoking
Stroke 1990N Engl J Med 1997
Circulation 2004
Best medical therapy: Antiplatelets
Antithrombotic Trialists’ collaboration (BMJ 2002)
Aspirin reduces the risk of TIA/ stroke/ death as monotherapy in high-risk patients
Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) (Circulation 2005)
Combination therapy reduces the incidence of asymptomatic embolization
Surgical treatment
Carotid endarterectomy (CEA)
?? Carotid angioplasty and stenting (CAS)
Superiority of CEA: Asymptomatic stenosis
Veterans Affairs Cooperative Trial (N Engl J Med 1993)
444 patients, asymptomatic stenosis >50%, Aspirin + CEA vs Aspirin
Lower incidence of ipsilateral stroke/ TIA (8.0% vs 20.6%, P< 0.001)
No difference in mortality in 30 days and 4 years
Asymptomatic Carotid Atherosclerosis Study (ACAS) (JAMA 1995)
1662 patients, asymptomatic stenosis > 60%, Aspirin +CEA vs Aspirin
Cerebral infarction decreased in surgery group (5.1% vs 11%)
Asymptomatic Carotid Surgery Trial (ACST) (Lancet 2004)
3120 patients, asymptomatic stenosis >60%
5 years risk reduction in stroke/ death in CEA group (6.4% vs 11%)
Superiority of CEA: Symptomatic stenosis
North American Symptomatic Carotid Endarterectomy Trial (NASCET) (N Engl J Med 1998)
randomised, prospective multicentre trial of 659 patients with symptomatic stenosis >70%
lower cumulative risk of any ipsilateral stroke at 2 years (9% vs 26%, P< 0.001)
reduction in rate of major/ fatal stroke in 2 years (2.5% vs 13.1%, P< 0.001)
European Carotid Surgery Trial (ECST) (Lancet 1998)
2518 patients
surgery benefits most to patients with severe stenosis >70%
Superiority of CEA
American Heart Association
American Stroke Association
Grade IA indication for CEA in carotid stenosis >70% regardless of symptom status
Grade IIA recommendation for CEA in asymptomatic men aged of 40-75 years with >60% stenosis
Surgery in only symptomatic women
Circulation, 2006
Any place for CAS?
Background of CAS
First successful carotid angioplasty by Klaus Mathias in 1980
Angioplasty without stent placement: poor results and complications
Primary adverse event in carotid atherosclerosis is embolization of plaque material
Stenting provides effective means of mechanical “plaque stabilization”
Carotid angioplasty with stenting readily replaces lone balloon angioplasty
CAS in symptomatic carotid stenosis
Stent-Protected Angioplasty vs Carotid Endarterectomy (SPACE) Trial
randomized multi-centre non-inferiority trial
1183 patients with severe symptomatic stenosis (>70%)
no significant difference between CAS and CEA in
30-day rate of stroke (6.84% vs 6.34%)
30-day rate of any stroke or death (7.7% vs 6.5%)
1 year rate of any stroke or death (9.6% vs 8.7%)
Failed to show non-inferiority of CAS in treatment of severe carotid stenosis
SPACE Collaborative Group, Lancet 2006
CAS in symptomatic carotid stenosis
Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) Trial
randomized multi-centre non-inferiority trial
527 symptomatic patients with severe stenosis (60-90%)
30-day rate of any stroke or death in CAS and CEA: 9.6% vs 3.9%
Failed to establish non-inferiority of CAS vs CEA
N Engl J Med 2006
CAS in symptomatic carotid stenosis
International Carotid Stenting Study (ICSS)
randomized controlled trial of 1713 patients
recently symptomatic carotid stenosis >50%
determine long-term survival free of disabling stroke
sufficient follow-up to be complete in 2011
30-day rate of stroke/ MI/ death of CEA and CAS: (5.1% vs 8.5%, hazard ratio 1.73, P=0.004)
Clear superiority of CEA over CAS
Cerebrovasc Dis 2009
CAS in asymptomatic carotid stenosis
Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) Trial
randomized multi-centre trial of 334 patients
68% patients asymptomatic with stenosis >80%
32% patients symptomatic with stenosis >50%
high risks: > 80 years/ significant heart or pulmonary disease/ contralateral carotid occlusion/ laryngeal nerve palsy/ prior radical neck surgery/ radiotherapy/ post-CEA restenosis
30-day MI/ stroke/ death rate for CAS/ CEA: 4.8% vs 9.8%, P= 0.09
1-year MI/ stroke/ death rate for CAS/ CEA: 12.2% vs 20.1%, P=0.048
CAS not inferior to CEA in treatment of high risk groupSAPPHIRE Investigators, N Engl J Med 2004
CAS in both asymptomatic and symptomatic carotid stenosis
Carotid Revascularization Endarterectomy vs Stent Trial (CREST)
prospective randomized multicentre trial of 2502 patients
108 centres in the USA
9 centres in Canada
both symptomatic (>50%) and asymptomatic (70%) carotid stenosis
exclusion criteria:
previous stroke severe enough to confound assessment of end-points
atrial fibrillation within 6 months/ necessitates anticoagulation
myocardial infarction within 30 days/ unstable angina
CREST Investigators, N Engl J Med 2010
During the periprocedure period, the incidence of the primary end-point was similar (5.2% vs 4.5%, hazard ratio for CAS, 1.18; P=0.01)
myocardial infarction more in CEA group (1.1% vs 2.3%, P=0.03)
stroke more in CAS group (4.1% vs 2.3%, P=0.01)
No significant difference from estimated 4-year rates of the primary end-point (7.2% vs 6.8%, hazard ratio for CAS, 1.11; P=0.51)
stroke rate in CAS still higher (6.4% vs 4.7%, P=0.03)
Findings from CREST
No modification of treatment effect by
symptomatic status (P=0.84)
gender (P=0.34)
Findings from CREST
Findings from CREST
Interaction between age and treatment effect (P=0.02)
vascular tortuosity
severe vascular calcification
Findings from CREST
CAS is associated with higher periprocedural risk of stroke, still significantly evident at 4 years
CEA is associated with higher periprocedural myocardial infarction and cranial palsies
Incidence of primary outcomes in both CAS and CEA is impressively low
• importance of training, credentialing & auditing of proceduralists
Selection for treatment requires attention to age
younger patients have better outcomes with CAS
older patients have better outcomes with CEA
Conclusion from CREST
Take home message
Strength of recommendationGrade 1: strong
Grade 2: weak
Quality of evidence
High: well conducted, large consistent RCTs
Moderate: inconsistent RCTs, observational studies
Low: observational studies, case series
Clinical guideline
Low grade stenosis (symptomatic <50%/ asymptomatic <60%)
optimal medical treatment (grade 1 recommendation; high quality evidence)
Symptomatic moderate to severe stenosis (>50%)
CEA + optimal medical treatment (grade 1 recommendation; high quality evidence)
Symptomatic moderate to severe stenosis (>50%) & high risk
CAS as an potential alternative to CEA (grade 2 recommendation; low quality evidence)
Asymptomatic moderate to severe stenosis (>60%)
CEA + optimal medical treatment (grade 1 recommendation; high quality evidence)
Against CAS except stenosis >80% or high anatomical risk for CEA (grade 1 recommendation; low quality evidence)
J Vasc Surg 2008
Thank you