Trials in carotid stenting

Endarterectomy vs stenting:

What have we learnt from CREST

study?

Vipul Gupta

Head,

Neurointervention

Medanta Institute of

Neurosciences

CREST: Study Design

Major eligibility criteria

Primary Endpoint

Periprocedural outcome- death, stroke,

MI

30-day endpoint components

Secondary Results – 2 year

Female sex ,

Diabetes , and dyslipidaemia

were independent predictors of

restenosis or occlusion after

the two procedures.

Restenosis or occlusion

Carotid artery stenting -

6%

Carotid endarterectomy -

6·3%

Smoking predicted an increased rate of restenosisafter carotid endarterectomybut not after carotid artery

stenting

Multi-centre randomized trials- the

controversy

Randomized controlled trials, the issue….

Management of MI as an

endpoint

Inclusion and ascertainment of

MI as a primary endpoint

Operator experience and

outcomes

Further analysis of CREST

Minor stroke worse than MI?

Neurological Residual Deficit Rates by NIHSS

Associated with Minor Strokes, Equal at 6 months

Long-term mortality after peri-procedural events:

No association with minor stroke, but strong

association of MI

Cranial nerve injury- not serious (not included

in primary end point) ?

No observed CAS-related

cranial nerve injury (CNI)

Less CAS access site complications

Death or Any Stroke Rates Decrease for CAS

over the Period of CREST Enrollment

Death or Major Stroke Rates in CAS

Decrease for Symptomatic Patients

Changes in Hazard Ratio by age group:

No age trend

Per protocol analysis

FDA Panel

•Circulatory Systems Devices panel of the

FDA on Jan 26, 2011

•Voted in favour of expanding use of

carotid stents to standard risk patients

Recommendations…

Guideline on the Management of Patients With

Extracranial Carotid and Vertebral Artery Disease

Published in journal- Stroke 2011

As accepted by: American Heart Association, American Stroke

Association, American Association of Neurological Surgeons, American

Society of Neuroradiology, Congress of Neurological Surgeons, Society

of NeuroInterventional Surgery, Society for Vascular Medicine, and

Society for Vascular Surgery

Recommendations for Carotid Revascularization

# Symptomatic patients- CEA if stenosis is more than 70%

(noninvasive imaging) or more than 50% by catheter angiography and

risk is less than 6% (Class I)

# CAS is indicated as an alternative to CEA for symptomatic patients

when the anticipated rate of periprocedural stroke or mortality is less

than 6% (Class I)

Latest guidiline – 2014 – less than 70 yrs, Cas may be preferable

Conclusions

CREST is the largest and most rigorous trial

Serious lacunae in European trials (training, MI,

credentialing, PD…)

CREST- CAS and CEA results are same

More minor strokes in CAS; more MI in CEA

Overall complication rates within acceptable limits,

serious stroke less than 1%

Long-term stroke rate/restenosis/occlusion – no

difference

Sub-analysis of CREST

Minor strokes recover

MI not benign

Cranial nerve injuries in CEA cannot not be

ignored

Stenting results kept improving during the trial

period- learning curve remains important