>> 0 >> 1 >> 2 >> 3 >> 4 >>

6

>> 0 >> 1 >> 2 >> 3 >> 4 >>

5

>> 0 >> 1 >> 2 >> 3 >> 4 >>

4

>> 0 >> 1 >> 2 >> 3 >> 4 >>

3

>> 0 >> 1 >> 2 >> 3 >> 4 >>

>> 0 >> 1 >> 2 >> 3 >> 4 >>

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Endovascular challenges for

the next decade

>> 0 >> 1 >> 2 >> 3 >> 4 >>

The ART of endovascular therapy

>> 0 >> 1 >> 2 >> 3 >> 4 >>

The way to your heart!

Radial approach

Femoral approach

Brachial approach

>> 0 >> 1 >> 2 >> 3 >> 4 >>

PCI in the treatment of AMI

Occluded RCA

Aspiration of thrombus

Direct stenting

Nice result

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Current affairs

>45 Clinical trialsHigh-technological diagnostic tools

High-technological therapeutical tools

IABP

Virtual Histology

Palpography

Rotablator

ELCA Laser

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Act from the heart…

>> 0 >> 1 >> 2 >> 3 >> 4 >>

…work on the brain

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Treatment of carotid stenosis

• Goal– Prevention of stroke

• Means– Carotid endarterectomy (CEA)– Carotid artery stenting (CAS)

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Carotid Endarterectomy (1)

• Carotid Endarterectomy– >50 years– Peri-operative combined mortality and major stroke risk is 2 – 5%

(6.5% in NASCET)

• Indicatons– Symptomatic patients + 70-99% stenosis (NNT 6 to prevent 1 major stroke at

2 years)

– Symptomatic patients + >60% stenosis still benefit, but less• NASCET (North American Symptomatic Carotid Endarterectomy Trial)

– Asymptomatic patients + >75% stenosis• ACST (European asymptomatic carotid surgery trial)

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Carotid Endarterectomy (2)

• Contra-indications– Complete internal carotid artery obstruction (because the

intraluminal thrombus then extends too far downstream, well into the intracranial portion of the artery, for endarterectomy to be successful)

– Previous stroke on the ipsilateral side with heavy sequelae because there is no point in preventing what has already happened

– Patient deemed unfit for the operation by the anaesthesiologist

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Carotid Endarterectomy (3)The long term benefits of carotid endarterectomy for both symptomatic and asymptomatic patients need to be weighed against the immediate risk of complications of the procedure, thus benefit is tangible only in the presence of a low perioperative complication rate. The surgical procedure should be performed by an experienced surgeon with good patient selection and as such continues to be the gold standard

>> 0 >> 1 >> 2 >> 3 >> 4 >>

A good stent is as good as a good endarterectomy

Horst Sievert, MD

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Stent trials

CAVATASSAPPHIRE

EVA-3SSPACE

>> 0 >> 1 >> 2 >> 3 >> 4 >>

CAVATAS

Carotid and Vertebral Artery Transluminal Angioplasty Study

The Lancet 2001; 357: 1729-1737

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Study design

Endovascular treatment(n=251)

504 patients with carotid stenosis

Carotid endarterectomy(n=253)

74% balloon angioplasty (n=158)26% stents (n=55)

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Outcome

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Conclusion

Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery, but with wide CIs. Endovascular treatment had the advantage of avoiding minor complications.

PS: Distal emboli-protection devices were not routinely used

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SAPPHIRE

Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients

N Engl J Med Volume 351;15:1493-1501 October 7, 2004

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Study design

Endovascular treatment(n=167)

334 high risk patients with carotid stenosisSymptomatic + 50% or Asymptomatic + 80% stenosis

Carotid endarterectomy(n=167)

100% Distal emboli-protection devices

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Major eligibility criteria

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Cumulative Incidence of Adverse Events

at 30 days and within 1 Year

At 30 days At 1 Year

?

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Conclusions

Among patients with severe carotid-artery stenosis and co-existing conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy.

Therefore, the less invasive approach may be an acceptable alternative among patients with high-risk carotid-artery stenosis.

>> 0 >> 1 >> 2 >> 3 >> 4 >>

EVA-3S

Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid

Stenosis

N Engl J Med, Volume 355(16):1660-1671, October 19, 2006

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Study design

Endovascular treatment(n=247)

527 patients with carotid stenosis ≥60% + Σ

Carotid endarterectomy(n=257)

91.1% Distal emboli-protection devices(change in protocol during study – 1/3 without recommendation)

>> 0 >> 1 >> 2 >> 3 >> 4 >>

EVA-3S Primary Endpoint @ 30dEVA-3S Primary Endpoint @ 30dCarotid Stenting vs EndarterectomyCarotid Stenting vs EndarterectomyCarotid Stenting vs EndarterectomyCarotid Stenting vs Endarterectomy

0.8%1.2% 0.7 (0.1-3.9)

0 1 2 3 4 5

0.68

Relative RiskRelative Risk± 95% CI± 95% CI

Relative RiskRelative Risk± 95% CI± 95% CIEndpoint

Death

Stroke

Death/Stroke

Stenting betterStenting better CEA betterCEA better

CEA(n=259)

Stenting(n=261)

RR (95% CI)unadjusted p-value

8.8%2.7% 3.3 (1.4-7.5) 0.004

9.6%3.9% 2.5 (1.2-5.1) 0.01

Mas JL et al. N Engl J Med 2006

>> 0 >> 1 >> 2 >> 3 >> 4 >>

EVA 3S

What was different from the other

trials?

>> 0 >> 1 >> 2 >> 3 >> 4 >>

EVA-3S

• Initially embolic protection was optional– 5/20 pts without embolic protection suffered

from a stroke!• Experienced Surgeons, unexperienced

Interventionalists– Surgeons: >25 endarterectomies /year– Interventionalists:

• Only 12 carotid stenting procedures were required

– Regardless of the result

• Some operators were even in training phase!

>> 0 >> 1 >> 2 >> 3 >> 4 >>

EVA-3S

• Unexperienced centers– 1.7 pts/year

• Aspirin + Plavix was not mandatory– Not prescribed in 15% !

• 2.4 % did not receive heparin!• Patients with high surgical risk were

excluded– But patients with high stent risk not!

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACE

Stent-Protected Angioplasty versus Carotid Endarterectomy

Lancet 2006;368:1239-47

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Study design

Carotid stenting(n=605)

1900 patients with carotid stenosis ≥70% + neurological symptoms

Carotid endarterectomy(n=595)

27% Distal emboli-protection devices

Stopped premature at 1200 ptn

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACE

• Trial stopped after the second interim-analysis (n=1200)– Patient recruitment too slow– Funding too low– Statistical power too low (37% chance for false negative

conclusion)

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACEPrimary Endpoint: Ipsilateral Stroke and Death @ 30 Days

6.846.34

012345678910

Surgery Stent

n.s.n.s.

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACEPrimary Endpoint: Ipsilateral Stroke and Death @ 30 Days

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACE

• "SPACE failed to prove non-inferiority of stenting compared with endarterectomy"

• No significant difference regarding the primary end-point

• No significant differences between CAS and CEA– Regarding secondary endpoints– Subgroups

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACE: Important to know

• Many centers/investigators had problems to fulfill the entrance criteria – Which were low!

• Only 25 carotid stent procedures!• Limited availability of embolic protection

devices (only few were allowed)– Some operators had limited experience with

those embolic protection devices allowed in the trial

• 73% of CAS performed without embolic protection

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACE: Important to know

• Not included as end-points (primary or secondary)– Myocardial infarction– Contralateral stroke– Cranial nerve palsy – Length of hospital stay– Other MAE

• Again, patients with high surgical risk were excluded but not patients with high stenting risk

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACE: Important to know

• Complete data monitoring in only 10% of the patients in each centre

• Trial stopped early

• Large pt numbers but still underpowered

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Don’t judge too quickly

>> 0 >> 1 >> 2 >> 3 >> 4 >>

SPACE did not show a difference between surgery and stenting, but imagine …

• … an excellent clinical trial– with experienced operators– randomized– controlled/monitored– multicenter– including all relevant endpoints– well powered

would show superiority of carotid surgery compared to stenting

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Then we would have the same situation as with coronary

stenting• We have a number of excellent clinical

trials PCI versus CABG– with experienced operators– randomized– controlled/monitored– multicenter– including all relevant endpoints– well powered

Showing superiority of CABG compared to PCI and coronary stenting

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Why is that?

Nobody cares!

Number of PCIs goes up,

number of CABG goes down!

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Take Home Messages

• In high grade carotid stenoses surgery is better than medical therapy

• The results of stent implantation are comparable to the results of surgery

• Therefore stent implantation is a treatment option in high grade stenosis

• EVA 3S and SPACE have shown again that stenting requires training and experience

• Nobody wants surgery

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Why should we stay behind?

We could start with aadjustedscreening program

n

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Patient selection

All specifically referred patients+

All patients send for coronarography and/or left-right catheterization, who are planned for CABG and/or valve

surgery

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Examinations

• Non-invasive– Duplex Carotids

• Invasive– Angiography using substraction and/or

rotational

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Duplex criteria

<1.5

<40

<120

<40%

Nonstenotic Nonstenotic plaqueplaque

>90%Ca. 80%60-70%40-60%Angiographic Angiographic estimatesestimates

Variable>3.7>1.8<1.8Systolic ratioSystolic ratio(ICA/CCA)(ICA/CCA)

Variable>100>40<40End diastolic End diastolic

velocity velocity (cm/s)(cm/s)

Variable>240>120>120Systolic peak Systolic peak

velocity velocity (cm/s)(cm/s)

Subtotal Subtotal stenosisstenosis

High-grade High-grade stenosisstenosis

Medium-Medium-grade grade

stenosisstenosis

Low-grade Low-grade stenosisstenosis

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Duplex Carotids

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Angiography (1)

• Aortic arch angio– 6F Pigtail– 45-50° LAO, no angulation– Automated injection (750 psi)

• 30 cc at 15 cc/s

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Angiography (2)

• Substraction– JR4 or SIM 1/2 catheter– Manual injection (min. 5cc dye/inj)

• 3x left CA, 3x right CA + 2x vertebral (0° angulation)

• 2x left cerebral, 2x right cerebral (15° cranial)

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Angiography (2)

• Rotational– SIM 1/2 catheter– RAO 120° LAO 120°, 0° angulation– Automated injection (450 psi !!)

• Carotids: 2x 16cc at 4cc/s met 0.5sec delay• Cerebral: 2x 16cc at 4cc/s and 1.5sec delay

– Manual injection of vertebral artery

>> 0 >> 1 >> 2 >> 3 >> 4 >>

Let’s dream of a better world

>> 0 >> 1 >> 2 >> 3 >> 4 >>

For further slides on these topics please feel free to visit the metcardio.org

website:

http://www.metcardio.org/slides.html