satish k surabhi, md,facc,fscai anmed health heart and ......yadav js, et al. n engl j med...
TRANSCRIPT
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Satish K Surabhi, MD,FACC,FSCAIMedical Director, Cardiac Cath Labs
AnMed Health Heart and Vascular Care
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NT
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Objectives
• Review the era of CEA trials• Reiterate the limitations of CEA trials• Review landmark carotid stent trials• Compare and contrast outcomes• Address ongoing advances in CAS
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Conflict of Interest• No financial conflict of interest relating to the
talk• Anticipate discussion on novel embolic
protection strategies• No conflict of interest, except…
- Interventional cardiologist with a passion for Carotid Artery Stenting
- Investigator in ongoing CAS trials.. EV3 ( CREATE-PAS and CREATE 2) Abbott Vascular ( CHOICE and CANOPY) Cordis ( SAPPHIRE)
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Carotid Artery Disease Natural History
• Symptomatic disease:- > 70% stenosis: 26% stroke risk at 2 years- 50%-70% stenosis: 22% stroke risk at 5 years
• Asymptomatic disease:- > 60% stenosis: 11% stroke risk at 5 years- > 80% stenosis: 35% stroke or TIA at 2 years- Ulcerated lesions: 5%-12% stroke per year
NASCET Trial. N Engl J Med 1991;325:445-453. ACAS Trial. JAMA 1995;273:1421-1428. ACST Trial. Lancet 2004;363:1491-1502.
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Carotid Endarterectomy
• Practiced for over 4 decades
• Safety well evaluated
• Superiority over medical therapy well established
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Risk of Stroke or Death in Symptomatic patientsRothwell et al, Stroke 1996
• 51 centers• Stroke and Death 5.6%• Death 1.6%
• Neurologist Assessor 7.7%• Neurologist Author 6.4%• Multiple Surgeons Author 5.5%• Single Surgeon Author 2.3%
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5.87.1
11.4
0
5
10
15
20
%
NASCET ECST Medicare
Risk of Stroke and DeathSymptomatic Carotid disease treated with CEA
Wholey MH, TCT 2002
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Carotid Stent Trials Carotid Stenting with Embolic Protection Devices
• ARCHeR• BEACH• CABERNERT• CARESS• CREST (RCT)
• MAVErICK• MedNova• SAPPHIRE (RCT)
• SHELTER• CREATE
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SAPPHIRE TrialStenting and Angioplasty in
Patients at High Risk for Endarterectomy
Yadav JS, et al. N Engl J Med 2004;351:1493-1501.
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High-Risk Criteria• Patients must have one or more of the following
conditions that place them at increased surgical risk:
- congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF < 30%
- open heart surgery needed within six weeks
- recent MI (> 24 hours and < 4 weeks)
- unstable angina (CCS class III/IV)
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High-Risk Criteria (Continued)
- severe pulmonary disease- contralateral carotid occlusion- contralateral laryngeal nerve palsy- radiation therapy to neck- previous CEA with recurrent stenosis- high cervical ICA lesions or CCA lesions below
the clavicle- severe tandem lesions- age greater than 80 years
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SAPPHIRE≥ 50% Stenosis - Symptomatic≥ 80% Stenosis - Asymptomatic
One or More Comorbidity CriteriaPhysician Team: Neurologist, Surgeon, Interventionalist
CONSENSUS
RANDOMIZED334
SURGICALREFUSAL
STENTREGISTRY
409
INTERVENTIONALREFUSAL
SURIGICALREGISTRY
7Stenting = 167 CEA = 167
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5.8
12.6
0
5
10
15
20
%
CAS CEA
SAPPHIRE TrialDeath, Stroke, MI @ One Month
P = 0.047
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SAPPHIRE: One-Year OutcomeDeath/Stroke/MI
Yadav JS. N Engl J Med 2004;351:1493-1501.
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SAPPHIRE: One-Year Outcome
CAS CEA P• Death/Stroke 5.5% 8.4% 0.36• Cranial nerve 0% 4.9% 0.004
palsy• Repeat 0.6% 4.3% 0.04
revascularization
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SAPPHIRE TrialCAS clearly and significantly
superior to CEA in patients with high risk criteria
Yadav JS, et al. N Engl J Med 2004;351:1493-1501.
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CREST• Carotid Revascularization Endarterectomy Versus Stenting Trial, 2004
and 2010• 117 centers in US and Canada • Randomized clinical trial comparing the safety and efficacy of CAS
versus CEA• Symptomatic patients had >50% by angiography, >70% by duplex, or
>70% by CT angiography and stroke or TIA within 180 days• Asymptomatic patients had >60% stenosis by angiography, >70% by
ultrasound, or >80% by CT angiography• Unlike other studies, interventionalist used only one stenting system and
the distal protection device was used in 96% of the stented patients
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CREST Summary• 2502 patients over a median 2.5 y FU
• 4y rates of the primary end point (CAS & CEA)
- 7.2% and 6.8%
- hazard ratio with stenting, 1.11 (95% confidence interval, 0.81 to 1.51; P = 0.51)
- no significant difference
• 4y rate of stroke or death 6.4% with CAS & 4.7% with CEA (hazard ratio, 1.50; P = 0.03)
- symptomatic patients 8.0% and 6.4% (hazard ratio, 1.37; P = 0.14)
- asymptomatic patients 4.5% and 2.7% (hazard ratio, 1.86; P = 0.07)
(Periprocedural event )
- death (0.7% vs. 0.3%, P = 0.18)
- stroke (4.1% vs. 2.3%, P = 0.01)
- myocardial infarction (1.1% vs. 2.3%, P = 0.03)
(After this period)
- Ipsilateral stroke with CAS and with CEA were similarly low
- (2.0% and 2.4%, respectively; P = 0.85)
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Kaplan-Meier analysis of the primary outcome (stroke, myocardial infarction, or death during the periprocedural period or any ipsilateral stroke within 4 years after randomization) for
patients undergoing carotid artery stenting or carotid endarterectomy.
©2010 by Cleveland Clinic
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CREST• “CREST demonstrated that with
experienced surgeons and interventionalists, both CEA and CAS are viable options for carotid revascularization because overall complication rates for both procedures are within current treatment guidelines”
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CEA has evolved and improved..
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Death/ MI/Stroke by EPS Usage
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High Risk CAS Data
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NIHSS at 6 months: equal
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CREST after 50% enrollmentAug 2006
Death or Major Stroke
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CREST after 50% enrollmentAug 2006
Death or Any Stroke
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CREST after 50% enrollmentMarch 2006
Symptomatic patients
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CREST after 50% enrollmentMarch 2006
Symptomatic patients
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CREST after 50% enrollmentAug 2006
Death or Major Stroke
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Operator Experience
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Operator Experience
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CAS Data Over Time
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Gore Flow reversal System
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Microembolic signals with Filter Vs MoMA
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PCath Lab
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High risk for CAS• Difficult arch• Extreme angulation• Extreme calcification• Possibly elderly at reasonable clinical risk
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Conclusions• CEA and CAS appear to be reasonably
similar means of carotid revascularization• Each has its strengths and weakness• Operator experience and improved
technology continues to improve both
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CAROTID ARTERY STENTING
Before After
1999
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CAROTID ARTERY STENTING2003
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RX ACCUNET™ Embolic Protection System
Carotid stent & Embolic protection devices
RX ACCULINK™
SpiderFX
PercuSurge
FilterWire EZ™
Acculink & Accunet systems Abbott Vascular Solutions
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Peri-procedural Death & Stroke
AHA Guideline 6.0%
Standard Surgical Risk High Surgical Risk Standard Surgical Risk
CAS CEA
High Surgical
Risk
Brott TG., et al. NEJM 2010
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4.2
15.4
0
5
10
15
20
%
CAS CEA
SAPPHIRE – Symptomatic PatientsDeath, Stroke, MI @ One Month
P = 0.13
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6.7
11.2
0
5
10
15
20
%
CAS CEA
SAPPHIRE – Asymptomatic PatientsDeath, Stroke, MI @ One Month
P = 0.33