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Editorial| Volume 34, ISSUE 4, P480-482, October 2007

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Endovascular or Surgical Treatment for Carotid Artery Stenosis?

  • J. Golledge
    Correspondence
    Corresponding author. Professor J. Golledge, Director, The Vascular Biology Unit, Department of Surgery, School of Medicine, James Cook University, Townsville, Queensland 4811, Australia.
    Affiliations
    Vascular Biology Unit, School of Medicine, James Cook University, Townsville, Australia
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Open ArchiveDOI:https://doi.org/10.1016/j.ejvs.2007.06.008
Endovascular or Surgical Treatment for Carotid Artery Stenosis?
Previous ArticleMeta-analysis of Randomized Trials Comparing Carotid Endarterectomy and Endovascular Treatment
Next ArticleHereditary Thrombophilia and Venous Thromboembolism: Critical Evaluation of the Clinical Implications of Screening
      The management of carotid atherosclerosis remains one of the most controversial areas of vascular practice despite attracting more randomised trials than any other problem in peripheral artery disease. Presently the most hotly debated topic is carotid stenting. Over the last decade there has been an increasing shift towards the endovascular treatment of most vascular beds. In many countries this also applies to the treatment of carotid stenosis. In this issue of The European Journal of Vascular and Endovascular Surgery Luebke and colleagues present a meta-analysis of trials comparing endovascular and surgical treatment of carotid stenosis. The main findings are that endovascular therapy was associated with increased risk of perioperative stroke, OR 1.50 (95% 1.05–2.16), but a reduced risk of cranial nerve injury, OR 0.15 (95% CI 0.09–0.26).
      • Luebke T.
      • Aleksic M.
      • Brunkwall J.
      Meta-analysis of randomized trials comparing carotid endarterectomy and endovascular treatment.
      Eur J Vasc Endovasc Surg. 2007; 34: 470-479
      No difference in outcome at one year was found, however, few of the studies have as yet reported at this time point. Based on these findings the authors concluded that endarterectomy remains the “gold standard” in the treatment of carotid stenosis and carotid stenting should only be carried out as part of an on-going randomised trial. It should be noted that the authors finding of a worse perioperative outcome in patients randomised to endovascular intervention only held for a fixed effect model and was not demonstrated with the statistically more conservative random effect model.
      • Luebke T.
      • Aleksic M.
      • Brunkwall J.
      Meta-analysis of randomized trials comparing carotid endarterectomy and endovascular treatment.
      Eur J Vasc Endovasc Surg. 2007; 34: 470-479
      An earlier meta-analysis by Coward and colleagues reached similar conclusions, although no difference in perioperative stroke rate was found.
      • Coward L.J.
      • Featherstone R.L.
      • Brown M.M.
      Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence.
      Stroke. 2005; 36: 905-911
      This study preceded two of the trials included in the present analysis.
      • The SPACE Collaborative Group
      30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.
      Lancet. 2006; 368: 1239-1247
      , 
      • Mas J.L.
      • Chatellier G.
      • Beyssen B.
      • Branchereau A.
      • Moulin T.
      • Becquemin J.P.
      • et al.
      Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
      N Engl J Med. 2006; 355: 1660-1671
      Of the seven trials examined in the meta-analysis of Luebke et al., five contributed most of the patients (Table 1).
      • The SPACE Collaborative Group
      30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.
      Lancet. 2006; 368: 1239-1247
      , 
      • Mas J.L.
      • Chatellier G.
      • Beyssen B.
      • Branchereau A.
      • Moulin T.
      • Becquemin J.P.
      • et al.
      Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
      N Engl J Med. 2006; 355: 1660-1671
      , 
      • CAVATAS Investigators
      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: 1729-1737
      , 
      • Alberts M.J.
      Results of a multicenter prospective randomized trial of carotid artery stenting vs. carotid endarterectomy.
      Stroke. 2001; 32 (Abstract): 325
      , 
      • Yadav J.S.
      • Wholey M.H.
      • Kuntz R.E.
      • Fayad P.
      • Katzen B.T.
      • Mishkel G.J.
      • et al.
      Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients.
      N Engl J Med. 2004; 351: 1493-1501
      Examination of the perioperative outcomes from these studies demonstrates a number of important points. Firstly, the findings of the five trials are quite variable. One trial found a significant two-fold higher perioperative stroke and death rate in patients randomised to endovascular intervention.
      • Mas J.L.
      • Chatellier G.
      • Beyssen B.
      • Branchereau A.
      • Moulin T.
      • Becquemin J.P.
      • et al.
      Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
      N Engl J Med. 2006; 355: 1660-1671
      Another smaller trial reported similar findings which were of borderline statistical significance.
      • Alberts M.J.
      Results of a multicenter prospective randomized trial of carotid artery stenting vs. carotid endarterectomy.
      Stroke. 2001; 32 (Abstract): 325
      The findings of the later study have only been reported in abstract form making examination of this trial problematic.
      • Alberts M.J.
      Results of a multicenter prospective randomized trial of carotid artery stenting vs. carotid endarterectomy.
      Stroke. 2001; 32 (Abstract): 325
      The other three main trials, including the largest study involving approximately 1200 patients, reported no difference in the main 30 day outcome between surgery and endovascular treatment (Table 1).
      • The SPACE Collaborative Group
      30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.
      Lancet. 2006; 368: 1239-1247
      , 
      • CAVATAS Investigators
      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: 1729-1737
      , 
      • Yadav J.S.
      • Wholey M.H.
      • Kuntz R.E.
      • Fayad P.
      • Katzen B.T.
      • Mishkel G.J.
      • et al.
      Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients.
      N Engl J Med. 2004; 351: 1493-1501
      The 30 day stroke and death rate varied from 5.4 to 12.1% in patients receiving endovascular intervention and 3.8 to 9.9% in those treated by surgery (Table 1).
      Table 1Perioperative outcome of patients randomised in the five main trials of endarterectomy and stenting in the treatment of carotid atherosclerosis
      StudyAsymptomatic30 d stroke/deathSignificanceMICranial nerve injuryStentProtection device
      EndovacularSurgeryEndovacularSurgeryEndovacularSurgery
      CAVATAS
      • CAVATAS Investigators
      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: 1729-1737
      		17/504 (3.4%)25/251* (10%)25/253* (9.9%)0.980/2513/253 (1.2%)0/25122/253 (8.7%)55/251 (21.9%)‡0/251
      WALLSTENT
      • Alberts M.J.
      Results of a multicenter prospective randomized trial of carotid artery stenting vs. carotid endarterectomy.
      Stroke. 2001; 32 (Abstract): 325
      		0/21913/107 (12.1%)5/112 (4.5%)0.049NSNSNSNS107/107 (100%)NS
      SAPPHIRE
      • Yadav J.S.
      • Wholey M.H.
      • Kuntz R.E.
      • Fayad P.
      • Katzen B.T.
      • Mishkel G.J.
      • et al.
      Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients.
      N Engl J Med. 2004; 351: 1493-1501
      		238/334 (71.3%)9/167† # (5.4%)13/167† # (7.8%)0.365/167¶ (3.0%)12/167¶ (7.2%)0/1678/167 (4.8%)159/167 (95.2%)‡159/167 (95.2%)‡
      SPACE
      • The SPACE Collaborative Group
      30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.
      Lancet. 2006; 368: 1239-1247
      		0/118346/599† (7.7%)38/584† (6.5%)0.1NSNSNSNS567/599 (94.7%)‡151/599 (25.2%)‡
      EVA-3S
      • Mas J.L.
      • Chatellier G.
      • Beyssen B.
      • Branchereau A.
      • Moulin T.
      • Becquemin J.P.
      • et al.
      Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
      N Engl J Med. 2006; 355: 1660-1671
      		0/52725/265 (9.4%)10/262 (3.8%)0.011/265 (0.4%)2/262 (0.8%)3/265 (1.1%)20/262 (7.6%)247/265 (93.2%)‡227/262 (86.6%)‡
      Total255/2767 (9.2%)118/1389** (8.5%)91/1378** (6.6%)6/683 (0.9%)17/682 (2.5%)3/683 (0.4%)50/682 (7.3%)1135/1389 (81.7%)537/1279 (42.0%)
      All data based on intention to treat. Stroke defined as focal neurological symptoms lasting more than *7 days or †1 day.
      # Included ipsilateral stroke up to 1 year after treatment; NS = not stated; ‡ rate based on intention to treat; ¶ included enzyme defined MI; ** Chi-squared for this comparison gives p=0.06 or 0.07 (corrected).
      N.B., 30d stroke/death rates ACAS 2.3%,
      • Executive Committee for the Asymptomatic Carotid Atherosclerosis Study
      Endarterectomy for asymptomatic carotid artery stenosis.
      JAMA. 1995; 273: 1421-1428
      ASCT 3.1%,
      • Halliday A.
      • Mansfield A.
      • Marro J.
      • Peto C.
      • Peto R.
      • et al.
      MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial.
      Lancet. 2004; 363: 1491-1502
      ECST 7.5%,
      • European Carotid Surgery Trialists' Collaborative Group
      Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).
      Lancet. 1998; 351: 1379-1387
      NASCET 5.8%.
      • Barnett H.J.
      • Taylor D.W.
      • Eliasziw M.
      • Fox A.J.
      • Ferguson G.G.
      • Haynes R.B.
      • et al.
      Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators.
      N Engl J Med. 1998; 339: 1415-1425
      This variability in outcome is quite concerning. The stroke-mortality rate in six of the 10 intervention groups from these five trials is higher than in any of the intervention groups from the original trials, which demonstrated the value of carotid endarterectomy over medical treatment (Table 1).
      • Executive Committee for the Asymptomatic Carotid Atherosclerosis Study
      Endarterectomy for asymptomatic carotid artery stenosis.
      JAMA. 1995; 273: 1421-1428
      , 
      • Halliday A.
      • Mansfield A.
      • Marro J.
      • Peto C.
      • Peto R.
      • et al.
      MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial.
      Lancet. 2004; 363: 1491-1502
      , 
      • European Carotid Surgery Trialists' Collaborative Group
      Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).
      Lancet. 1998; 351: 1379-1387
      , 
      • Barnett H.J.
      • Taylor D.W.
      • Eliasziw M.
      • Fox A.J.
      • Ferguson G.G.
      • Haynes R.B.
      • et al.
      Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators.
      N Engl J Med. 1998; 339: 1415-1425
      This finding is even more concerning when it is appreciated that three of the four trials which compared endarterectomy to medical therapy were completed in the 1990s when the value of anti-platelet medication, statins, Angiotensin II inhibition and β-blockade were less clear.
      • Executive Committee for the Asymptomatic Carotid Atherosclerosis Study
      Endarterectomy for asymptomatic carotid artery stenosis.
      JAMA. 1995; 273: 1421-1428
      , 
      • European Carotid Surgery Trialists' Collaborative Group
      Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).
      Lancet. 1998; 351: 1379-1387
      , 
      • Barnett H.J.
      • Taylor D.W.
      • Eliasziw M.
      • Fox A.J.
      • Ferguson G.G.
      • Haynes R.B.
      • et al.
      Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators.
      N Engl J Med. 1998; 339: 1415-1425
      Thus it is likely that the outcome for symptomatic carotid atherosclerosis treated by best medical therapy alone today would be considerable better than reported in NASCET and ECST.
      • European Carotid Surgery Trialists' Collaborative Group
      Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).
      Lancet. 1998; 351: 1379-1387
      , 
      • Barnett H.J.
      • Taylor D.W.
      • Eliasziw M.
      • Fox A.J.
      • Ferguson G.G.
      • Haynes R.B.
      • et al.
      Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators.
      N Engl J Med. 1998; 339: 1415-1425
      The stroke-mortality rates reported in the trials comparing endovascular and surgical treatment of carotid stenoses are well outside the thresholds acceptable for asymptomatic carotid intervention (Table 1). Although only one trial included a significant number of asymptomatic patients (71% in SAPPHIRE), it is hard to imagine that either intervention is adding much to the treatment of asymptomatic carotid stenosis based on these independent physician audited outcomes. As pointed out by Luebke and colleagues, endovascular therapy of carotid atherosclerosis is an evolving therapy. Placement of stents has now become standard, as has dual anti-platelet therapy. Cerebral protection devices are increasingly used for endovascular carotid stenting. The trial with the highest rate of protection device use reported the lowest perioperative stroke rate.
      • Yadav J.S.
      • Wholey M.H.
      • Kuntz R.E.
      • Fayad P.
      • Katzen B.T.
      • Mishkel G.J.
      • et al.
      Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients.
      N Engl J Med. 2004; 351: 1493-1501
      EVA-3S however had only a marginally lower protection device use but almost double the stroke-mortality rate of the SAPPHIRE study.
      • Mas J.L.
      • Chatellier G.
      • Beyssen B.
      • Branchereau A.
      • Moulin T.
      • Becquemin J.P.
      • et al.
      Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
      N Engl J Med. 2006; 355: 1660-1671
      The good outcome in the SAPPHIRE study may thus relate to the high percentage of asymptomatic stenoses treated in that trial (Table 1).
      Our conclusions must take into account the evolving nature of endovascular therapy. The trials presently on-going may give a more realistic appraisal of the value of endovascular therapy in a setting where technology and protocols have become more established.
      • Hobson 2nd, R.W.
      • Howard V.J.
      • Roubin G.S.
      • Brott T.G.
      • Ferguson R.D.
      • Popma J.J.
      • 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: 1106-1111
      It can however be noted from the table that the perioperative endovascular outcomes were little improved in the recent EVA-3S trial compared to the first major trial in which no protective devices were available and stenting was frequently not performed.
      • Mas J.L.
      • Chatellier G.
      • Beyssen B.
      • Branchereau A.
      • Moulin T.
      • Becquemin J.P.
      • et al.
      Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
      N Engl J Med. 2006; 355: 1660-1671
      , 
      • CAVATAS Investigators
      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: 1729-1737
      It would thus appear appropriate to continue investigation of endovascular therapy for symptomatic carotid atherosclerosis as part of on-going trials which are already established. It would presently appear inappropriate to treat asymptomatic carotid atherosclerosis by endovascular means in most instances. Indeed it remains uncertain that the excellent perioperative outcomes reported for endarterectomy in ACAS and ACST can be reproduced in general practice.
      • Executive Committee for the Asymptomatic Carotid Atherosclerosis Study
      Endarterectomy for asymptomatic carotid artery stenosis.
      JAMA. 1995; 273: 1421-1428
      , 
      • Halliday A.
      • Mansfield A.
      • Marro J.
      • Peto C.
      • Peto R.
      • et al.
      MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial.
      Lancet. 2004; 363: 1491-1502
      Ultimately, the lesions for which endovascular therapy is most appropriate may reflect the strength of this technique and the weaknesses of endarterectomy. Few would argue with the use of carotid stenting for symptomatic restenosis, in the presence of past neck irradiation or when the stenosis is surgically inaccessible. Endarterectomy is clearly more appropriate however when the aortic arch is markedly unfolded and atheromatous making an endovascular pathway to the carotid artery hazardous.

      References

        • Luebke T.
        • Aleksic M.
        • Brunkwall J.
        Meta-analysis of randomized trials comparing carotid endarterectomy and endovascular treatment.
        Eur J Vasc Endovasc Surg. 2007; 34: 470-479
        View in Article
        • Coward L.J.
        • Featherstone R.L.
        • Brown M.M.
        Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence.
        Stroke. 2005; 36: 905-911
        View in Article
        • The SPACE Collaborative Group
        30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial.
        Lancet. 2006; 368: 1239-1247
        View in Article
        • Mas J.L.
        • Chatellier G.
        • Beyssen B.
        • Branchereau A.
        • Moulin T.
        • Becquemin J.P.
        • et al.
        Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis.
        N Engl J Med. 2006; 355: 1660-1671
        View in Article
        • CAVATAS Investigators
        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: 1729-1737
        View in Article
        • Alberts M.J.
        Results of a multicenter prospective randomized trial of carotid artery stenting vs. carotid endarterectomy.
        Stroke. 2001; 32 (Abstract): 325
        View in Article
        • Yadav J.S.
        • Wholey M.H.
        • Kuntz R.E.
        • Fayad P.
        • Katzen B.T.
        • Mishkel G.J.
        • et al.
        Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigators. Protected carotid-artery stenting versus endarterectomy in high-risk patients.
        N Engl J Med. 2004; 351: 1493-1501
        View in Article
        • Executive Committee for the Asymptomatic Carotid Atherosclerosis Study
        Endarterectomy for asymptomatic carotid artery stenosis.
        JAMA. 1995; 273: 1421-1428
        View in Article
        • Halliday A.
        • Mansfield A.
        • Marro J.
        • Peto C.
        • Peto R.
        • et al.
        MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial.
        Lancet. 2004; 363: 1491-1502
        View in Article
        • European Carotid Surgery Trialists' Collaborative Group
        Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST).
        Lancet. 1998; 351: 1379-1387
        View in Article
        • Barnett H.J.
        • Taylor D.W.
        • Eliasziw M.
        • Fox A.J.
        • Ferguson G.G.
        • Haynes R.B.
        • et al.
        Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators.
        N Engl J Med. 1998; 339: 1415-1425
        View in Article
        • Hobson 2nd, R.W.
        • Howard V.J.
        • Roubin G.S.
        • Brott T.G.
        • Ferguson R.D.
        • Popma J.J.
        • 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: 1106-1111
        View in Article

      Article info

      Publication history

      Accepted: June 14, 2007

      Footnotes

      ☆JG is funded by the National Institute of Health, USA (RO1 HL080010-01), National Heart Foundation and NHMRC, Australia (project grant 379600, fellowship 431503).

      Identification

      DOI: https://doi.org/10.1016/j.ejvs.2007.06.008

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      © 2007 Published by Elsevier Inc.

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