Is there any future for carotid stenting?
Transcript of Is there any future for carotid stenting?
Is there any future for carotid stenting?Proximal protection and
mesh-covered stents are the answer
Peter A. Schneider, MD
Kaiser Foundation Hospital
Honolulu, Hawaii
Disclosure
Peter A. Schneider
.................................................................................
I have the following potential conflicts of interest to report:
Scientific Advisory Board (non-paid): Cardinal, Abbott, Medtronic
Royalty (modest): Cook
Co-founder and Chief Medical Officer: Intact, Cagent
Enter patients into studies: NIH, Bard, Gore, Medtronic, BSI,
Silk Road (no financial relationship).
VIVA Board member (nonprofit)
Periprocedural Endpoints in CREST
Too Many Minor Strokes
1,081 Asymptomatic patients CASEvents (%)
CEAEvents (%)
P value
Major Stroke 3 (0.5) 2 (0.3) 0.66
Minor Stroke 12 (2.0) 6 (1.0) 0.15
Stroke and death 15 (2.5) 8 (1.4) 0.15
MI 7 (1.2) 13 (2.2) 0.76
Silver et al. Stroke 2011;42:675
1,321 Symptomatic patients CASEvents (%)
CEAEvents (%)
P value
Major Stroke 8 (1.2) 6 (0.9) 0.61
Minor Stroke 29 (4.3) 15 (2.3) 0.042
Stroke and death 40 (6.0) 21 (3.2) 0.019
MI 7 (1.0) 15 (2.3) 0.083
Too Many
DW-MRI HitsCAS: up to 70%
CEA: up to 27%
Leal et al. Eur J Vasc Endovasc Surg 2010;39:661
Most are temporary, not associated with neurologic deficits.
Not clear if there is associated long-term cognitive deficit.
Use as a surrogate end point for neurological risk.
Recent meta-analysis
CAS 40.3%
CEA 12.2%Garguilo et al. Plos 2015;10:137
How to get better results?
Prior to CAS During CAS After CAS
1h to 30d
CREST Randomization
High Risk for CAS?
• Tortuous arch
• Calcified arch
• Diseased great vessels
• Tortuous carotid artery
• Pre-occlusive lesion
• Heavy plaque burden
• Circumferential calcification
• Echolucent plaque
Future of Carotid Revascularization
Protection Devices
Method of Protection
Approach Advantages Disadvantages
Distal Filter Fixed or free-wire filter system
Most experience, most patients can be treated(Several approved)
Incomplete filtration, less versatile for crossing lesion
Cessation offlow
Distal occlusion Lowest profile for crossing lesion (Percu-surge)
Intolerance, vessel damage at balloon site
Cessation of flow
Proximal balloon occlusion
No need to cross lesion, can treat bad ICA lesion (Mo-Ma)
Adds risk in a bad arch, intolerance
Reversal of flow
Direct cervical-proximal clamp
Better removal of emboli, simple, avoid arch (T-CAR)
Neck incision, no good inhostile neck, intolerance
) .N<O/.,%P%32%+/E%B*373823>%+2%Q$Q%&' ((%
Z)[ )\L)
PROFI:
Prospective Randomized Trial of
Proximal Balloon Occlusion vs Filter
Bijuklic K et al. J Am Coll Cardiol 2012;59:1383
Fewer DW-MRI Hits
With Proximal Protection
Armour Trial(n=220)
MAE Total 2.7%
Major Stroke 0.9%
Minor Stroke 1.4%
Death 0.9%
MI 0
TIA 0.9%
Ansel et al. Catheter Cardiovasc Interv 2010;76:1
Proximal Protection Better than Distal Filter
Incidence of new ischemic lesions by DW-MRI
Stabile et al. JACC Cardiovasc Interv 2014;7:1177
Fewer MRI Hits with Proximal Protection Using MoMa
Proximal Protection (MoMa) Better than Distal Filter
Giri et al. JACC Cardiovasc Interv 2015;8:609
Stroke Location
10,200 patients in the NCDR CARE Registry
Non-ipsilateral events
were responsible for
1/3 to 1/2 of the strokes.
Bonati et al. Lancet Neurology 2010;1016:1474
ICSS MRI Subset
45% of the new
cerebral lesions
after CAS were
non-ipsilateral
What about non-ipsilateral lesions?
Stroke Risk at 30 Days with Distal Filter Protection
CREST Results CAS CEA
All Stroke 4.1% 2.3%
Ipsilateral Stroke 2.0% 2.3%
Almost half of the strokes
were non-ipsilateral
Proximal Protection with Reversed Flow
TCAR-Transcervical Approach
First commercial case in US
Roadster IIPIs Vik Kashyap and Peter Schneider
Planning enrollment of >600 cases
Protection during all phases
More efficient particle capture
Avoid the arch
ROADSTER 2:Clinical Outcomes
ROADSTER 1 ROADSTER 2 ROADSTER 2n=203 n=227 n=252
Patients with 30-day F/U
Patients with 30-day F/U
All Patients
Stroke/Death/MI 6 3.0% 2 0.9% 2 0.8%Stroke 1 0.5% 2 0.9% 2 0.8%Death 2 1.0% 0 0.0% 0 0.0%MI 3 1.5% 0 0.0% 0 0.0%
Stroke/Death 3 1.5% 2 0.9% 2 0.8%CNI (permanent) 0 0.0% 0 0.0% 0 0.0%
Patients Treated Per Protocol
ROADSTER 2 Stroke in Asymptomatic Patients = 0.5%
ROADSTER 2 Stroke in Symptomatic Patients = 1.3%
Amazing array of configurations and morphologies
What About the Stent?
ScaffoldingLesion containmentConformabilityFatigue resistanceEase of re-crossingVisibilityLow profile
Schnaudigel et al. Stroke 2008;39:911
Closed Open
Closed cell (n=48)
Open cell(n=48)
P value
27.3% 51.1% 0.020
Park et al. J Neurosurg 2013;119:
More DW-MRI Lesions
with Open Cell Stents
Prospective RCT: MRI Hits
Closed versus Open Cell Stents
More Plaque Prolapse with Open Cell Stents
Plaque prolapse between stent struts
deDonato et al. Eur J Vasc Endovasc Surg 2013;45:479
Plaque Prolapse
Open Cell Closed Cell
61.5% 17.6%
Wholey J Endovasc Ther 2009;16:178
More Neurologic Events with Open Cell Stents
Belgian-Italian RegistryBosiers et al. Eur J Vasc Endovasc Surg 2007;33:135
SPACE Trial Olav J et al. Stroke 2009;40:841
Closed Open
Neurologic Events After 24 Hours
Bosiers et al. Eur J Vasc Endovasc Surg 2007;33:135
2/3 of neuro
events were
delayed (1-30d)
0-24 hours 1-30d % of strokes that occurred after 24 hours
29 events 19 events 40%
Hill et al. Circulation 2012;126:3054
CREST-Timing of Stroke After Carotid Stenting
Mesh-Covered Stents
Roadsaver
Mesh coverage for sustained embolic prevention
Retrievable and repositionable
5Fr delivery
Closed cell, woven structure
Microvention/Terumo
– Confidence Trial-for US approval
– MRI Study• 30% had new MRI lesions, all resolved at 30dRuffino et al. Cardiovasc Intervent Radiol 2016;39:1541
– Roadsaver Italian Registry• 150 patients enrolled, MRI subset
• 30 days: No stroke, death or TIA
• 3 Italian centersNerla et al. Eurointervent 2016;12(5) Aug 5
– Clear Road Trial• Enrolling 100 patients
– Update by K Deloose
• 12 European centers
Mesh-Covered StentsGORE Carotid Stent
– Open Cell Nitinol
Frame
– Closed Cell 500 µ
lattice on outside of
Frame
– Permanently Bound
CBAS Heparin on all
device surfaces
Trial enrolled
Expect results at CX
Mesh-Covered Stents
SCAFFOLD Trial
Design-Prospective study comparing GORE® Carotid Stent to a performance goal developed from CEA outcomes
50 sites, 312 subjects.
Co-Pis: Bill Gray and Peter Schneider
Objective-Evaluate safety and efficacy of GORE® Carotid Stent in patients at increased risk for adverse events from carotid endarterectomy.
Primary endpoint-Death, stroke, or myocardial infarction through 30 days plus ipsilateral stroke between 31 days and 1 year.
Mesh-Covered Stents
CGuard Prime EPS
Polyethylene Terephthalate (PET)
20µ wide fiber micronet on a nitinol
stent
Attached to proximal and distal
crowns of the stent
InspireMD
CARANET Study-30 patient trial
No stroke or death at 30 days
New DW-MRI lesions at 48h: 37%J Schoefer et al. JACC: Cardiovasc Interv
2015;8: 1229.
IRON-Guard Multicenter Italian
Registry: 200 patients, 30 d
manuscript in publication. 2.5%
stroke, 20% new DW-MRI lesions Setacci et al. J Cardiovasc Surg
2015;56:787
Mesh Covered Stent Designs
Gore Terumo Roadsaver InspireMDCGuardTM
Design
Aperture Size 500µ 300µ 180µ
Materials PTFE mesh (Heparin coated)on nitinol stent
nitinol on nitinol PET MicroNetTM
on nitinol stent
CE Mark No Yes Yes
Future of Carotid Stenting
ConclusionHigher risk of minor stroke in perioperative period
with CAS. Must be improved to make CAS a
viable therapy.
Proximal protection appears to be more complete
than filters and similar to endarterectomy.
Mesh covered stents may provide better lesion
containment with less potential for embolization
through the stent.
Is there any future for carotid stenting?Proximal protection and
mesh-covered stents are the answer
Peter A. Schneider, MD
Kaiser Foundation Hospital
Honolulu, Hawaii