Assessment: Carotid Endarterectomy ― An Evidence-Based Review
Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med...
Transcript of Satish K Surabhi, MD,FACC,FSCAI AnMed Health Heart and ......Yadav JS, et al. N Engl J Med...
Satish K Surabhi, MD,FACC,FSCAIMedical Director, Cardiac Cath Labs
AnMed Health Heart and Vascular Care
NT
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
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)
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.
Carotid Endarterectomy
• Practiced for over 4 decades
• Safety well evaluated
• Superiority over medical therapy well established
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%
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
Carotid Stent Trials Carotid Stenting with Embolic Protection Devices
• ARCHeR• BEACH• CABERNERT• CARESS• CREST (RCT)
• MAVErICK• MedNova• SAPPHIRE (RCT)
• SHELTER• CREATE
SAPPHIRE TrialStenting and Angioplasty in
Patients at High Risk for Endarterectomy
Yadav JS, et al. N Engl J Med 2004;351:1493-1501.
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)
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
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
5.8
12.6
0
5
10
15
20
%
CAS CEA
SAPPHIRE TrialDeath, Stroke, MI @ One Month
P = 0.047
SAPPHIRE: One-Year OutcomeDeath/Stroke/MI
Yadav JS. N Engl J Med 2004;351:1493-1501.
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
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.
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
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)
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
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”
CEA has evolved and improved..
Death/ MI/Stroke by EPS Usage
High Risk CAS Data
NIHSS at 6 months: equal
CREST after 50% enrollmentAug 2006
Death or Major Stroke
CREST after 50% enrollmentAug 2006
Death or Any Stroke
CREST after 50% enrollmentMarch 2006
Symptomatic patients
CREST after 50% enrollmentMarch 2006
Symptomatic patients
CREST after 50% enrollmentAug 2006
Death or Major Stroke
Operator Experience
Operator Experience
CAS Data Over Time
Gore Flow reversal System
Microembolic signals with Filter Vs MoMA
PCath Lab
High risk for CAS• Difficult arch• Extreme angulation• Extreme calcification• Possibly elderly at reasonable clinical risk
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
CAROTID ARTERY STENTING
Before After
1999
CAROTID ARTERY STENTING2003
RX ACCUNET™ Embolic Protection System
Carotid stent & Embolic protection devices
RX ACCULINK™
SpiderFX
PercuSurge
FilterWire EZ™
Acculink & Accunet systems Abbott Vascular Solutions
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
4.2
15.4
0
5
10
15
20
%
CAS CEA
SAPPHIRE – Symptomatic PatientsDeath, Stroke, MI @ One Month
P = 0.13
6.7
11.2
0
5
10
15
20
%
CAS CEA
SAPPHIRE – Asymptomatic PatientsDeath, Stroke, MI @ One Month
P = 0.33