The Consensus Statement includes two parts, the Consensus Statement itself, and the Recommendation to the European Stroke Organisation (ESO) on revision of ESO Guidelines. Please note that the final text of the Guidelines, is decided by ESO and that the recommendation in this document may not be the final guidelines version. As soon as the guidelines are confirmed, they will appear on this website as well as on the ESO website www.eso-stroke.org

A. Karolinska Stroke Update Consensus Statement

Carotid Endarterectomy vs angioplasty

The following Consensus Statement was adopted by the 7th Karolinska Stroke Update meeting on November 17, 2008.

The consensus statement was proposed by the chairman of the session, Professor Jean-Louis Mas, Paris, the co-chair Professor Philip Bath, Nottingham, and the session secretary Dr Konstantinos Kostulas, Stockholm, together with the speakers of the session. The statement was then finally approved by the participants of the meeting, after listening to the different presentations.
The speakers in this session were Professor Michael Hennerici, Mannheim, Professor Jean-Louis Mas, Paris and Professor Martin Brown, London.

Controversy to discuss at the 2008 consensus session:

• Is there sufficient evidence to support the conclusion that carotid stenting is as safe as surgery and provides long-term protection against stroke that is similar to that of surgery?

Background

Several large-scale randomised clinical trials (RCTs) have compared carotid stenting and carotid endarterectomy for secondary prevention in patients with severe symptomatic carotid stenosis (1-8). None of these studies was adequately powered to show the non-inferiority (or superiority) of stenting compared to endarterectomy with regard to an endpoint combining the early risks and late benefits of the procedures. Most studies were designed to assess the non-inferiority of stenting compared to endarterectomy with regard to the early risks of the procedures.

Discussion

CAS has not been shown to be as safe as CEA in patients with symptomatic carotid artery stenosis in RCTs. Two recent meta-analyses (7, 8) of RCTs that compared endovascular and surgical treatment of patients with mainly symptomatic carotid artery stenosis do not support a change from the current recommendation that carotid surgery is the standard treatment for symptomatic carotid artery stenosis.
In RCTs, the risk of ipsilateral stroke beyond the perioperative period was low (< 1% per year) and similar in both the stenting and endarterectomy groups, which strongly suggests that stenting is as effective as surgery for the medium-term prevention of ipsilateral stroke, at least for the first 4 years after the procedures (1, 4-6).  As the incidence of recurrent carotid stenosis may be significantly higher after carotid stenting than after carotid endarterectomy (5), there is a need to assess the long-term effects of carotid stenting, and particularly the effect of restenosis.

Subgroups analyses from RCTs suggest some heterogeneity of risk between stenting and endarterectomy. In particular, the excess risk associated with stenting was greater in patients aged 70 years or older (4, 9, 10). However, owing to the drawbacks of post hoc analyses, such as low statistical power and the risk of chance findings, these subgroup analyses should be interpreted with caution. The best evidence for subgroup treatment effect interaction will be obtained from a planned combined analysis of individual patient data from current trials that compare stenting with endarterectomy.

Conclusion

• Until the results of the on-going trials are available for a pooled analysis of safety and long-term effectiveness, stenting should not be routinely offered to patients suitable for carotid endarterectomy.

References:

1. Endovascular versus surgical treatment in patients with carotid stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): a randomised trial. Lancet 2001; 357: 1729–37.

2. Mas JL, Chatellier G, Beyssen B, et al. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006; 355: 1660–71.

3. Ringleb PA, Allenberg J, Bruckmann H, et al. 30-day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised noninferiority trial. Lancet 2006; 368: 1239–47.

4. Mas JL, Trinquart L, Leys D, et al. Endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial. Lancet Neurol 2008; 7: 885–92.

5. Eckstein HH, Ringleb PA, Allenberg J-R, et al. Stent-protected angioplasty versus carotid endarterectomy for symptomatic stenoses (SPACE): two-year results. Lancet Neurol 2008; 7: 893–902.

6. Gurm HS, Yadav JS, Fayad P, et al. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med 2008; 358: 1572–79.

7. Ederle J, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis.Cochrane Database Syst Rev 2007; 3: CD000515.

8. Ringleb PA, Chatellier G, Hacke W, et al. Safety of endovascular treatment of carotid artery stenosis compared with surgical treatment: a meta-analysis. J Vasc Surg 2008; 47: 350–55.

9. Stingele R, Berger J, Alfke K, et al. Clinical and angiographic risk factors for stroke and death within 30 days after carotid endarterectomy and stent-protected angioplasty: a subanalysis of the SPACE study. Lancet Neurol 2008; 7: 216–22.

10. Hobson RW, Howard VJ, Roubin GS, et al. Carotid artery stenting is associated with increased complications in octogenarians: 30-day stroke and death rates in the CREST lead-in phase. J Vasc Surg 2004; 40: 1106–11.

B. Recommendation by Karolinska Stroke Update participants to ESO Guidelines Committee to revise ESO guidelines:

No changes of the current ESO guidelines were suggested.