Carotid stent team
• Jeremy Chattaway
• Nick Cheshire
• Rodney Foale/Jamil Mayet/Iqbal Malik
• Martin Clark
Background
• Then:– “PTCA is barbaric and without evidence as a
treatment for CAD”
• Now:– Coronary stenting accepted as standard therapy
for CAD
• Could the same happen for carotid stenting?
Pre-requisites for success
• Prove surgery is better than tablets
• Prove percutaneous approach is almost as good as surgery
• Add stents/adjunctive therapy to make percutaneous equivalent to surgery
Case RH-1
• Age 63 male
• PMH Severe ARLAD
stenosisPoor LV
• Risk FactorsHT LipidsDM PVDEx- Smoking
• Cerebrovascular Hx
“TIA” 15 yrs ago
Asymptomatic now
• Cardiac Hx
increasing dyspnoea
no angina
Case RH-2
• Investigations
ECG Lat ST sag
Echo LV7/8cm
Mod severe AR
Creatinine 152 K 3.8
Hb 15.0
INR 1.2
• CVD Investigations
Duplex
MRA
Arch angio
Case RH-3
• Medication– Warfarin Digoxin 125mic– Bisoprolol 2.5 Amlodipine 5– Enalapril 15 bd Pravastatin 40– Imdur 30 Clopidogrel 75– Frusemide 40
Plan of action-RH
• Aim– Reduce CVA risk prior to AVR and grafts
• Rationale– Discussed twice at neurovascular meeting
• Risks of CEA high-not a suitable candidate
– Discussed twice at Joint cardiology/surgery meeting
• Needs AVR otherwise cardiac lifespan limited
– Discussed by CAS team
Evidence based medicine
• Risk of AVR/CABG
– >3000 ptsCVA risk
– Stenosis <50% 1.6%– Stenosis 50-99%
3.8%– Occlusion 6.5%– Occ+stenosis 25%
• CEA plus CABG/AVR
– CEA first• Cardiac risk very high
– Cardiac/CEA togather• Shorter stay 10 days• Higher CVA/death risk?• 9.5% vs 5.7% 30d risk
– Cardiac first• Asymptomatic >70%
stenosis 1%/yr CVA
Final Plan- RH
• Do Both Carotids with stents?
• Do one carotid only?– Risk of hyperperfusion
injury– Improve hemodynamic
reserve– Try second one later
RH
• Rx with aspirin + clopidogrel for 4 weeks
• Returned for AVR 4 weeks later– LIMA graft to LAD– Bileaflet AVR– Remarkable recovery
• Plan for home day 7
– Returned to ITU day 7• chest infection
– Home day 12
Pre-requisites for success
• Prove surgery is better than tablets
• Prove percutaneous approach is almost as good as surgery
• Add stents/adjunctive therapy to make percutaneous equivalent to surgery
Background
• Stroke in the population– 12% of all deaths in UK are due to CVA– 1 million CVA in Europe/year
• Carotid stenosis is major cause of CVA– Recent symptoms-28% 2-year risk CVA– Incidence of carotid stenosis >80% 0.3-2.4% of
population
Why have a stent program?
• CEA tricky
– Restenosis– Not C2-C7– Hostile neck
• RT• Surgery• Scars
– High risk• Medical Morbidity• Neuro Morbidity• RLN palsy contralat
• CAS
– Minimally Invasive– No scar– No GA Easy– Equivalent– Treatment of occlusion
post CEA
• Eastcott/ Debakey 1953 CEA
• NASCET (659)– >70% stenosis– 2-yr fu CVA 9% vs 26% on medical Rx
• ECST (3024)– >60% stenosis– 3-yr fu CVA 14.9% vs 26.5% on medical Rx
• ACAS– >60% stenosis– 5-yr fu CVA 5.1% vs 11% on medical Rx
Prove surgery is better than tablets
Prove percutaneous approach is almost as good as surgery
• Carotid and vertebral artery angioplasty study– Randomisation 1992-1997– 560 pts– 504 PTA vs surgery
– 86% stenosis
• Only 55 stents used– One CVA at time of stent.
CAVATAS
PTA Surgery p
30d death/CVA
10% 9.9% p=ns
CN palsy 0% 9% p<0.0001
Haematoma 1% 7% P=0.0015
MI 0% 0.8% ns
Re-stenosis 17% 5% P<0.0001
CAVATAS
• QOL same• Cost in lab same• Total cost greater for surgery as ITU stay
– £946
• Stent – cost of PTA from £1086 to £1864
Carotid Stenting
• At first…– 5 out of 7 had CVA with stent (RCT 1998)– 219 patients- death<1 year/CVA
12.1% stent vs. 3.6% CEA (p = 0.022). (RCT
2001)
• Randomised Trials
Stent vs surgery
• ICSS
• SPACE- Stent-protected Percutanous Angioplasty-Carotid Endarterectomy trial
• EVA-3S- Endarterectomy versus angioplasty in patients with severe symptomatic carotid stenosis study
• CREST- Carotid Revascularisation Endarterectomy vs stenting trial
• SAPPHIRE-Stenting and Angioplasty with protection in Patients with High Risk for Endarterectomy
Trial UpdateRandomized Studies
• CAVATAS completed(only 30% stent use)
• CREST (NIH/NHLBI)(U.S., 2500 pts., low risk)
• SAPPHIRE(U.S., 600-900 pts., high risk population
• CAVATAS 2 (society initiated)(worldwide 2000 pts.)
• SPACE (society initiated)(Germany, 1900 pts.)
High Risk Registriesincluding 2400 patients
• ARCHeR• Maverick• Beach• Mednova• Cabernet
Asymptomatic
Data Treatment 30d CVA/death
ACAS Medical
CEA
0.4%
3%
Mathias CAS c DPD 1.6%
Wholey No DPD
DPD
3.97%
1.75%
Metanala CEA 3.4%
SAPPHIRE
2002
CAS c DPD
CEA
6.7%
11.2%
Data Treatment 30d CVA/death
NASCET Medical
CEA
3%
6.5%
ECST Medical
CEA
3%
7%
Wholey No DPD
DPD
6.7%
2.82%
CAVATAS CEA
CAS
9.9% (6.4)
9.9% (4.0)
SAPPHIRE
2002
CAS c DPD
CEA
4.2%
15.4%
Symptomatic
Flanders study
Stenosis
Not suitable for CEA7.5%
Not suitable for CAS12.75%
CEA/CAS
Patient choice
CAS71%
CEA29%
ICSS entry criteria
Inclusion• >40• >70% stenosis• Extracranial IC or
bifurcation lesion
Excusion• CVA with no recovery• Can’t stent
– Tortuous– Thrombus– Common carotid stenosis– Pseudo-occlusion
• Can’t op
ICSS outcome events
• Death/ any CVA• TIA• MI<30d• CN palsy<30d• Hematoma (tx/op/long
stay)
• >70% stenosis at FU• Reintervention
• QOL• Costs
Conclusion
• The carotid is 25 years behind the coronary• It is catching up fast.
• Different vessel and vascular bed (cf diabetes)
• The multidisciplinary team
• SMH at the lead
Distal protection devicesDevice Pore size Delivery Retrieval PrepnRubicon
wire100Max
2F (0.028) nil nil
Angioguard XP (OTW)
100Max 8mm
3.2-3.9F
(2 wires)
OTW
5.1F
On table
CordisEpi-filter EX
Or EZ (Mono)80-110
3.5-5.5mm
EX 3.9F
EZ 3.0F
Mono
Sheath
On table
BostonSpider
(OTW)120-1303-7mm
2.9F Mono sheath
On table
EV3Interceptor
wire100
<6.5mm
2.9F Medtronic
TRAP
(OTW)100
<7mm
3.5F 4.5F Loading
EV3
Distal Protection devicesDevice Pore
sizeDelivery Retrieval Prepn
Arteria
(Parodi)- 10F nil Reverse
flow
Prox occ.MOMA
(OTW)- 11F 4.2-4.9F Not flow
reversal
Prox occ.Mednova
Percusurge (OTW/mono)
- - Distal occ.