journal club

1. Journal Club
DR BHAVIN J PATEL
DM NEUROLOGY RESIDENT
GMC AND MBS HOSPITAL, KOTA

2. Trial 1
Trial 2

3. Background
Carotid artery stenosis (CS) accounts for up to 20-25% of all
ischemic strokes.
Treatment of carotid artery stenosis:-
 Medical treatment (MT)
Carotid revascularization (CR)
1. Carotid endarterectomy (CEA)
2. Carotid artery stenting (CAS).

4. Purpose—Stenting for symptomatic carotid stenosis carries a
higher risk of procedural stroke or death than carotid
endarterectomy (CEA).
It is unclear that this extra risk of stroke is more on procedural
day or from day1 to 30.

6. Methodology
Trial is meta-analysis of four following randomized clinical trials:-
 EVA-3S trial (Endarterectomy Versus Angioplasty in Patients With
Symptomatic Severe Carotid Stenosis)
 SPACE trial (Stent-Protected Angioplasty Versus Carotid Endarterectomy)
 ICSS (International Carotid Stenting Study)
CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial).

7. Methodology
All trials included patients with symptomatic moderate to
severe carotid stenosis (≥50% reduction of lumen diameter)
Use Distal filters were mandatory in EVA-3s trial while it was
optional in other trials.

9. Statistical analysis
Per protocol analysis
The CAS versus CEA treatment effect was expressed as an odds
ratio (OR) with 95% CI.
P<0.05 was considered to indicate statistical significance
All statistical analyses were performed using the statistical software
environment R

10. Outcome
The primary outcome event for this analysis was stroke or death
occurring either on the day of treatment (immediate procedural
event) or within 1 to 30 days thereafter (delayed procedural event).

11. Result

12. Patient characteristics

13. Patient characteristics

14. Comparison of stroke on
procedural perioed

15. Predictors of event in stenting group

16. Predictors of event in endarterectomy
group

17. Discussion
About two-thirds (110 of 169) of all procedural stroke or death outcomes in
CAS and about half (42 of 88) of the events in CEA occurred on the day of
procedure.
Risk of procedural stroke or death was significantly higher in CAS than in
CEA, but between 1 and 30 days thereafter, the risk was similar in both
treatment groups

18. Discussion
The use of distal filter devices, was associated with an increased risk of new
ischemic brain lesions after the procedure
To avoid the necessity of navigating the aortic arch with potentially difficult
anatomy, alternative access routes, such as direct carotid access, have been
proposed systems exerting
A reversal of blood flow before the lesion is crossed with the catheter have
been introduced and appear to lower the risk of thromboembolism.

19. Limitations
Information regarding mechanism of stroke across all 4 contributing trials
was not collected.
They did not mentioned whether the events occurred on day of procedure
was occurred during or after the procedure.
There has been substantial progress in the development of new stent
designs, the introduction of cerebral protection devices, and new access
routes,

20. Trial 2

21. Background
Endarterectomy and stenting aim to lower the long-term risk of stroke in
patients with atherosclerotic disease of the carotid artery
Findings on long-term patency of the treated carotid artery after each
procedure have been conflicting
Eight trial reported restenosis after carotid vascularization
Three trial reported more chances of restenosis in stenting than
endarterectomy.

22. Methodology
Patients with carotid stenosis associated with ipsilateral transient
ischaemic attack or stroke symptoms within the 12 months before inclusion
All patients provided written informed consent to participate in the trial
before randomization
Patients were randomly assigned to treatment by stenting or
endarterectomy in a 1:1 ratio

24. Procedure
Carotid imaging was done prior to randomization to confirm >50%
stenosis.
The interventionist used their discretion to choose stents and cerebral
protection devices.
Surgeons could do either standard or eversion endarterectomy, under
local or general anaesthesia, with or without the use of shunts or patches

25. Follow up
Patients were followed up at 30 days after treatment then at 6
months after randomisation and annually thereafter.
Duration of follow up was 5 year initially but was extended to 10
yrs.

26. Outcome
To quantify the long-term risk of at least moderate (≥50%)
restenosis up to 10 years.
To ascertain whether restenosis predisposed to a higher risk of
subsequent stroke.
To investigate the risk factors predisposing to restenosis.

27. Statistical analysis
Per protocol analysis
Cumulative incidence of restenosis over years was calculated by
Kaplan meier method.
Event hazards between patients without restenosis and those with
restenosis Was compared using Cox proportional hazards models

28. Patient characteristics

29. Patient characteristics

30. Comparison of restenosis in
CAS vs CEA

31. Risk of ipsilateral stroke after
restenosis

32. Discussion
The long-term risk of moderate or higher (≥50%) restenosis,
or occlusion of the carotid artery, was significantly higher after
stenting than after endarterectomy.
The risk of severe (≥70%) carotid restenosis, or occlusion, did
not differ between treatment groups.

33. Discussion
SPACE trial:- severe restenosis (≥70%) 2 years after stenting were
significantly higher than after endarterectomy (10∙7% vs 4∙6%; p=0·0009)
EVA-3S trial:- moderate or higher (≥50%) restenosis at 3 years—higher
after stenting than after endarterectomy (13% vs 5%; p=0·02)
CREST trial:- 10-year incidence of severe carotid restenosis(≥70%)- did not
differ between the stenting (12·2%) and endarterectomy (9·7%) groups (HR
1·24, 95% CI 0·91–1·70)

34. Discussion
The increase in stroke risk in patients with restenosis was
significantly higher after initial treatment with endarterectomy,
but not after initial treatment with stenting.

35. Discussion
Independent risk factor for restenosis:-
 Older age, female sex
 Current or past smoking,
 Non-insulin dependent diabetes
 Uncontrolled hypertension
 A greater extent of stenosis in the contralateral carotid artery
 Higher total serum cholesterol

36. Discussion
In CREST, women, patients with diabetes, and those with
dyslipidaemia were also at greater risk of restenosis after either
treatment, as were smokers after endarterectomy.
Statin use at 30 days after treatment was not associated with any
change in the risk of restenosis.

37. Limitations
Velocity measurements were analysed as recorded by local investigators.
The true effect of restenosis on risk for recurrent stroke could have been
underestimated because restenosis might only have been diagnosed after a
stroke occurred
Data neither allow to draw firm conclusions on the usefulness of regular
ultrasound follow-up after carotid revascularisation nor justify repeat
revascularisation in patients with restenosis

38. Conclusion
The increased risk of stroke or death in the stenting group is limited to the
day of procedure demonstrates the need to improve the procedural safety of
CAS
Moderate or higher (≥50%) restenosis occurred more frequently after
stenting than after endarterectomy.
Restenosis after revascularisation of the carotid artery increased
significantly the risk for subsequent stroke.

39. References
Naylor AR. Endarterectomy versus stenting for stroke prevention. Stroke and Vascular
Neurology 2018;0: e000146.
Eckstein HH, et al. the Stent-Protected Angioplasty versus Carotid Endarterectomy
(SPACE) Lancet Neurol. 2008;7:893–902
Sheffet AJ et al.the Carotid Revascularization Endarterectomy vs. Stenting Trial
(CREST). Int J Stroke. 2010;5:40–46.
Leo H Bonati et al. the International Carotid Stenting Study investigators, Lancet Neurol
2018; 17: 587–96
Mas JL et al EVA-3S Investigators, study of endarterectomy versus angioplasty in
patients with symptomatic severe carotid stenosis trial. Stroke. 2014;45:2750–2756

40. Thank you

41. ESVS Guidelines 2018

42. Naylor AR. Endarterectomy versus stenting for stroke prevention. Stroke and Vascular Neurology 2018;0: e000146.

43. ESVS Guidelines 2018
Naylor AR. Endarterectomy versus stenting for stroke prevention. Stroke and Vascular Neurology 2018;0: e000146.

44. ESVS Guidelines 2018
Naylor AR. Endarterectomy versus stenting for stroke prevention. Stroke and Vascular Neurology 2018;0: e000146.

45. ESVS Guidelines 2018
Naylor AR. Endarterectomy versus stenting for stroke prevention. Stroke and Vascular Neurology 2018;0: e000146.