SHA 24 February 2013
“Neurologist”
“Patient”
Nothing ASA & Physio CEA Modify RF
CAS Lytic Stenting
POBA BMS DESs DEB Bioabsorbable
Endarterectomy
1954
1977
Volume
Complications
Carotid stenting
1995 2011
Source: William A. Gray MD, Presented at Oxford University, England
7
Trial
30-Day Outcome (Death/Stroke)
EVA-3S (30 days)
CEA: 3.9%
CAS: 9.6%
p=0.01
ICSS (120 days)
CEA: 4.7%
CAS: 8.5%
p=0.001
CREST (Symptomatic Only)
CEA: 5.4%
CAS: 6.7%
p=0.30
Source: William A. Gray MD, Presented at Oxford University, England
8
Operator Experience
Trial
EVA-3S
Poor
ICSS
Poor
CREST
Adequate for era
(12 lifetime CAS or 35 supra-aortics with 5 CAS)
(50 stents anywhere, 10 lifetime CAS)
Source: William A. Gray MD, Presented at Oxford University, England
9
Trial
MI Ascertainment and Rates
EVA-3S
Not a primary endpoint. Ascertainment not described. CAS: 0.4% CEA: 0.8%
SPACE
Not a primary or secondary endpoint. No routine ascertainment. No MI’s reported.
ICSS
Not a primary endpoint. Not routine ascertainment. CAS: 0.4% CEA: 0.5%
CREST
Part of the primary endpoint. Routine surveillance. CAS: 1.1% CEA: 2.3%
Source: William A. Gray MD, Presented at Oxford University, England
10
EPD Use
Trial
EVA-3S
Not mandated until after the first 80 patients treated; ~20% of all CAS strokes
SPACE
27%
CREST
>95%
Source: William A. Gray MD, Presented at Oxford University, England
11
Trial
EPD Use
MI Ascertainment
Operator Experience
EVA-3S
+
0
0
SPACE
½+
0
++
+
0
0
++
++
++
ICSS
CREST
Source: William A. Gray MD, Presented at Oxford University, England
12
AHA Standards Symptomatic carotid stenosis: <6% CEA stroke and death rate ď&#x201A;Ą
Asymptomatic carotid stenosis: <3% CEA stroke and death rate
ď&#x201A;Ą
Per Protocol
Accunet® EPS Used N = 1,073
EPS Not Used N = 24
Difference [95% CI]1
All Death, Stroke, and MI2
5.3%
20.8%
-15.5% [-31.8%, 0.8%]
Death2
0.4%
8.3%
-8.0%
ANM
All Stroke2
3.8%
8.3%
-4.5%
ANM
Major Stroke
0.7%
4.2%
-3.4%
ANM
Minor Stroke
3.1%
4.2%
-1.1%
ANM
1.9%
8.3%
-6.5%
ANM
MI2
Note: Only includes each subject’s first occurrence of the event. 1 By normal approximation. 2 Hierarchical event in first row, all other are non-hierarchical events. 3 ANM: Assumptions Not Met Source: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM247780.pdf
14
Why Embolic Protection?
MCA (M1) embolic occlusion
Proximal vs Distal Proximal : Flow Reversal 1. Gore 2. Invatec/Medtronic Distal: Filter or occlusive balloon 1.Abbott 2.Cordis
Proximal devices •Occlusion balloons in the external & common carotid artery resulting in cessation of flow in the internal carotid artery. •Proximal balloon occlusion linked to a venous return site, retrograde blood flow in the internal carotid artery occurs. •Following stent insertion, the proximal internal carotid artery is suctioned to remove debris prior to deflating the occlusion balloon Disadvantages: •They are larger than distal devices >> bigger sheaths •Cerebral ischemia may occur during flow reversal. •Injury to the common & external carotid arteries may occur with balloon inflation.
ECA Balloon Reversal of blood flow in ICA with aspiration of debris
CCA Balloon
Distal Devices •Triple coaxial catheter : distal occlusion balloon with proximal aspiration of blood & debris following inflation. •Other devices: deploy distal filters instead of balloons.
Disadvantages : • They must cross the stenosis • Tight lesions may require predilatation before device placement • They may induce vasospasm that can severely narrow the outflow & cause stroke if prolonged • Difficulty with removal of the device itself