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Meta-Analysis
. 2020 Feb 25;2(2):CD000515.
doi: 10.1002/14651858.CD000515.pub5.

Carotid artery stenting versus endarterectomy for treatment of carotid artery stenosis

Mandy D Müller  1 , Philippe Lyrer  1 , Martin M Brown  2 , Leo H Bonati  1   2
Affiliations
Meta-Analysis

Carotid artery stenting versus endarterectomy for treatment of carotid artery stenosis

Mandy D Müller et al. Cochrane Database Syst Rev. .

Abstract

Background: Carotid artery stenting is an alternative to carotid endarterectomy for the treatment of atherosclerotic carotid artery stenosis. This review updates a previous version first published in 1997 and subsequently updated in 2004, 2007, and 2012.

Objectives: To assess the benefits and risks of stenting compared with endarterectomy in people with symptomatic or asymptomatic carotid stenosis.

Search methods: We searched the Cochrane Stroke Group Trials Register (last searched August 2018) and the following databases: CENTRAL, MEDLINE, Embase, and Science Citation Index to August 2018. We also searched ongoing trials registers (August 2018) and reference lists, and contacted researchers in the field.

Selection criteria: Randomised controlled trials (RCTs) comparing stenting with endarterectomy for symptomatic or asymptomatic atherosclerotic carotid stenosis. In addition, we included RCTs comparing carotid artery stenting with medical therapy alone.

Data collection and analysis: One review author selected trials for inclusion, assessed trial quality and risk of bias, and extracted data. A second review author independently validated trial selection and a third review author independently validated data extraction. We calculated treatment effects as odds ratios (OR) and 95% confidence intervals (CI), with endarterectomy as the reference group. We quantified heterogeneity using the I² statistic and used GRADE to assess the overall certainty of evidence.

Main results: We included 22 trials involving 9753 participants. In participants with symptomatic carotid stenosis, compared with endarterectomy stenting was associated with a higher risk of periprocedural death or stroke (the primary safety outcome; OR 1.70, 95% CI 1.31 to 2.19; P < 0.0001, I² = 5%; 10 trials, 5396 participants; high-certainty evidence); and periprocedural death, stroke, or myocardial infarction (OR 1.43, 95% CI 1.14 to 1.80; P = 0.002, I² = 0%; 6 trials, 4861 participants; high-certainty evidence). The OR for the primary safety outcome was 1.11 (95% CI 0.74 to 1.64) in participants under 70 years old and 2.23 (95% CI 1.61 to 3.08) in participants 70 years old or more (interaction P = 0.007). There was a non-significant increase in periprocedural death or major or disabling stroke with stenting (OR 1.36, 95% CI 0.97 to 1.91; P = 0.08, I² = 0%; 7 trials, 4983 participants; high-certainty evidence). Compared with endarterectomy, stenting was associated with lower risks of myocardial infarction (OR 0.47, 95% CI 0.24 to 0.94; P = 0.03, I² = 0%), cranial nerve palsy (OR 0.09, 95% CI 0.06 to 0.16; P < 0.00001, I² = 0%), and access site haematoma (OR 0.32, 95% CI 0.15 to 0.68; P = 0.003, I² = 27%). The combination of periprocedural death or stroke or ipsilateral stroke during follow-up (the primary combined safety and efficacy outcome) favoured endarterectomy (OR 1.51, 95% CI 1.24 to 1.85; P < 0.0001, I² = 0%; 8 trials, 5080 participants; high-certainty evidence). The rate of ipsilateral stroke after the periprocedural period did not differ between treatments (OR 1.05, 95% CI 0.75 to 1.47; P = 0.77, I² = 0%). In participants with asymptomatic carotid stenosis, there was a non-significant increase in periprocedural death or stroke with stenting compared with endarterectomy (OR 1.72, 95% CI 1.00 to 2.97; P = 0.05, I² = 0%; 7 trials, 3378 participants; moderate-certainty evidence). The risk of periprocedural death or stroke or ipsilateral stroke during follow-up did not differ significantly between treatments (OR 1.27, 95% CI 0.87 to 1.84; P = 0.22, I² = 0%; 6 trials, 3315 participants; moderate-certainty evidence). Moderate or higher carotid artery restenosis (50% or greater) or occlusion during follow-up was more common after stenting (OR 2.00, 95% CI 1.12 to 3.60; P = 0.02, I² = 44%), but the difference in risk of severe restenosis was not significant (70% or greater; OR 1.26, 95% CI 0.79 to 2.00; P = 0.33, I² = 58%; low-certainty evidence).

Authors' conclusions: Stenting for symptomatic carotid stenosis is associated with a higher risk of periprocedural stroke or death than endarterectomy. This extra risk is mostly attributed to an increase in minor, non-disabling strokes occurring in people older than 70 years. Beyond the periprocedural period, carotid stenting is as effective in preventing recurrent stroke as endarterectomy. However, combining procedural safety and long-term efficacy in preventing recurrent stroke still favours endarterectomy. In people with asymptomatic carotid stenosis, there may be a small increase in the risk of periprocedural stroke or death with stenting compared with endarterectomy. However, CIs of treatment effects were wide and further data from randomised trials in people with asymptomatic stenosis are needed.

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Conflict of interest statement

MDM: none.

PL: was involved as local principal investigator (PI) in the CAVATAS‐CEA 2001, CAVATAS‐MED 2009, and ICSS 2010 trials. He was a member of the steering committee as well as PI in the BACASS trial. He was not involved in data extraction from ICSS and CAVATAS trials.

MMB: was the chief investigator of three completed trials (CAVATAS‐CEA 2001; CAVATAS‐MED 2009; ICSS 2010), and one ongoing trial (EVA‐3S 2006). He was not involved in data extraction from ICSS and CAVATAS.

LHB: was a member of the ICSS writing committee. He contributed to the analysis of data in CAVATAS‐CEA 2001, CAVATAS‐MED 2009, and ICSS 2010 trials, and is a member of the ECST‐2 and ACST‐2 steering committees. He was not involved in data extraction from CAVATAS‐CEA 2001, CAVATAS‐MED 2009, and ICSS 2010 trials.

Figures

1
1
Study flow diagram.
1.1
1.1. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 1 Primary safety outcome: death or any stroke between randomisation and 30 days after treatment.
1.2
1.2. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 2 Death or any stroke between randomisation and 30 days after treatment according to age.
1.3
1.3. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 3 Death or any stroke between randomisation and 30 days after treatment according to sex.
1.4
1.4. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 4 Death or any stroke between randomisation and 30 days after treatment according to minimum pretrial experience in endovascular treatment of carotid stenosis.
1.5
1.5. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 5 Death or major or disabling stroke between randomisation and 30 days after treatment.
1.6
1.6. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 6 Death of any cause between randomisation and 30 days after treatment.
1.7
1.7. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 7 Any stroke between randomisation and 30 days after treatment.
1.8
1.8. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 8 Fatal, major, or disabling stroke between randomisation and 30 days after treatment.
1.9
1.9. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 9 Myocardial infarction between randomisation and 30 days after treatment.
1.10
1.10. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 10 Death or any stroke or myocardial infarction between randomisation and 30 days after treatment.
1.11
1.11. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 11 Primary combined safety and efficacy outcome: death or any stroke between randomisation and 30 days after treatment or ipsilateral stroke until the end of follow‐up.
1.12
1.12. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 12 Death or any stroke between randomisation and end of follow‐up.
1.13
1.13. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 13 Any stroke during follow‐up (periprocedural events and people dying in the periprocedural period excluded).
1.14
1.14. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 14 Ipsilateral stroke during follow‐up (periprocedural events and people dying in the periprocedural period excluded).
1.15
1.15. Analysis
Comparison 1 Stenting or endarterectomy for symptomatic carotid stenosis, Outcome 15 Death or any stroke or myocardial infarction between randomisation and 30 days after treatment or ipsilateral stroke until end of follow‐up.
2.1
2.1. Analysis
Comparison 2 Stenting or endarterectomy for asymptomatic carotid stenosis, Outcome 1 Death or any stroke between randomisation and 30 days after treatment.
2.2
2.2. Analysis
Comparison 2 Stenting or endarterectomy for asymptomatic carotid stenosis, Outcome 2 Death or major or disabling stroke between randomisation and 30 days after treatment.
2.3
2.3. Analysis
Comparison 2 Stenting or endarterectomy for asymptomatic carotid stenosis, Outcome 3 Myocardial infarction between randomisation and 30 days after treatment.
2.4
2.4. Analysis
Comparison 2 Stenting or endarterectomy for asymptomatic carotid stenosis, Outcome 4 Death or any stroke or myocardial infarction between randomisation and 30 days after treatment.
2.5
2.5. Analysis
Comparison 2 Stenting or endarterectomy for asymptomatic carotid stenosis, Outcome 5 Death or any stroke between randomisation and 30 days after treatment or ipsilateral stroke until end of follow‐up.
2.6
2.6. Analysis
Comparison 2 Stenting or endarterectomy for asymptomatic carotid stenosis, Outcome 6 Death or any stroke or myocardial infarction between randomisation and 30 days after treatment or ipsilateral stroke until end of follow‐up.
3.1
3.1. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 1 Death or any stroke between randomisation and 30 days after treatment.
3.2
3.2. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 2 Fatal, major, or disabling stroke between randomisation and 30 days after treatment.
3.3
3.3. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 3 Death of any cause between randomisation and 30 days after treatment.
3.4
3.4. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 4 Any stroke between randomisation and 30 days after treatment.
3.5
3.5. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 5 Myocardial infarction between randomisation and 30 days after treatment.
3.6
3.6. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 6 Death or any stroke or myocardial infarction between randomisation and 30 days after treatment.
3.7
3.7. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 7 Death or any stroke between randomisation and 30 days after treatment or ipsilateral stroke until end of follow‐up.
3.8
3.8. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 8 Death or any stroke or myocardial infarction between randomisation and 30 days after treatment or ipsilateral stroke until end of follow‐up.
3.9
3.9. Analysis
Comparison 3 Stenting or endarterectomy in people with elevated surgical risk, Outcome 9 Any stroke during follow‐up (periprocedural events and people dying in the periprocedural period excluded).
4.1
4.1. Analysis
Comparison 4 Restenosis in endovascular treatment or endarterectomy for symptomatic or asymptomatic carotid stenosis, Outcome 1 Severe (≥ 70%) restenosis during follow‐up.
4.2
4.2. Analysis
Comparison 4 Restenosis in endovascular treatment or endarterectomy for symptomatic or asymptomatic carotid stenosis, Outcome 2 Moderate (≥ 50%) or severe (≥ 70%) restenosis during follow‐up.
5.1
5.1. Analysis
Comparison 5 Access complications in stenting versus endarterectomy, Outcome 1 Cranial nerve palsy within 30 days of procedure.
5.2
5.2. Analysis
Comparison 5 Access complications in stenting versus endarterectomy, Outcome 2 Death or neurological complication up to 30 days after treatment.
5.3
5.3. Analysis
Comparison 5 Access complications in stenting versus endarterectomy, Outcome 3 Access site haematoma.
6.1
6.1. Analysis
Comparison 6 Endovascular treatment or medical care in people considered not suitable for surgery, Outcome 1 Death or any stroke between randomisation and end of follow‐up.
7.1
7.1. Analysis
Comparison 7 Balloon angioplasty with/without stent insertion or endarterectomy for symptomatic carotid stenosis, Outcome 1 Death or any stroke between randomisation and 30 days after treatment.
7.2
7.2. Analysis
Comparison 7 Balloon angioplasty with/without stent insertion or endarterectomy for symptomatic carotid stenosis, Outcome 2 Any stroke during follow‐up (periprocedural events and people dying in the periprocedural period excluded).
7.3
7.3. Analysis
Comparison 7 Balloon angioplasty with/without stent insertion or endarterectomy for symptomatic carotid stenosis, Outcome 3 Death or any stroke between randomisation and 30 days after treatment or ipsilateral stroke until the end of follow‐up.
7.4
7.4. Analysis
Comparison 7 Balloon angioplasty with/without stent insertion or endarterectomy for symptomatic carotid stenosis, Outcome 4 Ipsilateral stroke during follow‐up (periprocedural events and people dying in the periprocedural period excluded).
7.5
7.5. Analysis
Comparison 7 Balloon angioplasty with/without stent insertion or endarterectomy for symptomatic carotid stenosis, Outcome 5 Severe (≥ 70%) restenosis during follow‐up.
8.1
8.1. Analysis
Comparison 8 Balloon angioplasty with/without stent insertion or endarterectomy for asymptomatic carotid stenosis, Outcome 1 Death or any stroke between randomisation and 30 days after treatment.
8.2
8.2. Analysis
Comparison 8 Balloon angioplasty with/without stent insertion or endarterectomy for asymptomatic carotid stenosis, Outcome 2 Death or any stroke between randomisation and 30 days after treatment or ipsilateral stroke until the end of follow‐up.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

ACT‐1 2016 {published data only}
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BACASS 2008 {published data only}
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Beijing 2003 {published data only}
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Beijing 2009 {published data only}
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Beijing 2013 {published data only}
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Carmel Medical Center 2017 {published data only}
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CAVATAS‐CEA 2001 {published data only}
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CAVATAS‐MED 2009 {published data only}
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CREST 2010 {published and unpublished data}
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EVA‐3S 2006 {published and unpublished data}
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    1. Mas JL, Arquizan C, Calvet D, Viguier A, Albucher JF, Piquet P, EVA‐3S Investigators. Long‐term follow‐up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial. Stroke 2014;45(9):2750‐6. - PubMed
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Houston 2014 {published data only}
    1. Kougias P, Collins R, Pastorek N, Sharath S, Barshes NR, McCulloch K, et al. Comparison of domain‐specific cognitive function after carotid endarterectomy and stenting. Journal of Vascular Surgery 2015;62(2):355‐61. - PubMed
ICSS 2010 {published and unpublished data}
    1. Altinbas A, Zandvoort MJ, Berg E, Jongen LM, Algra A, Moll FL, et al. Cognition after carotid endarterectomy or stenting: a randomised comparison. Neurology 2011;77(11):1084‐90. - PubMed
    1. Bonati LH, Dobson J, Featherstone RL, Ederle J, Worp HB, Borst GJ, ICSS Investigators. Long‐term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial. Lancet 2014;385(9967):529‐38. - PMC - PubMed
    1. Bonati LH, Gregson J, Dobson J, McCabe DJ, Nederkoorn PJ, Worp HB, ICSS Investigators. Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial. Lancet Neurology 2018;17(7):587‐96. - PMC - PubMed
    1. Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoorn PJ, ICSS MRI study group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurology 2010;9(4):353‐62. - PubMed
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Kentucky 2001 {published data only}
    1. Brooks WH, Jones MR, Gisler P, McClure RR, Coleman TC, Breathitt L, et al. Carotid angioplasty with stenting versus endarterectomy: 10‐year randomized trial in a community hospital. Journal of the American College of Cardiology: Cardiovascular Interventions 2013;7(2):163‐8. - PubMed
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Kentucky 2004 {published data only}
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Leicester 1998 {published data only}
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Ostrava 2014 {published and unpublished data}
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Regensburg 2008 {published data only}
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SAPPHIRE 2004 {published data only}
    1. Gurm HS, Yadav JS, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, SAPPHIRE Investigators. Long‐term results of carotid stenting versus endarterectomy in high‐risk patients. New England Journal of Medicine 2008;358(15):1572‐9. - PubMed
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SPACE 2006 {published data only}
    1. Eckstein HH, Ringleb P, Allenberg JR, Berger J, Fraedrich G, Hacke W, et al. Results of the Stent‐Protected Angioplasty versus Carotid Endarterectomy (SPACE) study to treat symptomatic stenoses at 2 years: a multinational, prospective, randomised trial. Lancet Neurology 2008;7(10):893‐902. - PubMed
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SPACE‐2 2016 {published data only}
    1. Eckstein HH, Reiff T, Ringleb P, Jansen O, Mansmann U, Hacke W, SPACE Investigators. SPACE‐2: a missed opportunity to compare carotid endarterectomy, carotid stenting, and best medical treatment in patients with asymptomatic carotid stenoses. European Journal of Vascular and Endovascular Surgery 2016;51(6):761‐5. - PubMed
    1. Reiff T, Stingele R, Eckstein HH, Fraedrich G, Jansen O, Mudra H, SPACE2‐Study Group. Stent‐protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy: SPACE2 – a three‐arm randomised‐controlled clinical trial. International Journal of Stroke 2009;4(4):294‐9. - PubMed
TESCAS‐C 2006 {published data only}
    1. TESCAS‐C (Ling) study, 2006. www.trialresultscenter.org/evidenceTable/viewtrial.aspx?trial=8539 (accessed prior to 28 August 2019).
    1. Ling F, Jiao LQ. Preliminary report of trial of endarterectomy versus stenting for the treatment of carotid atherosclerotic stenosis in China (TESCAS‐C). Chinese Journal of Cerebrovascular Diseases 2006;3(1):4‐8.
WALLSTENT 2001 {published and unpublished data}
    1. Alberts MJ. Results of a multicentre prospective randomized trial of carotid artery stenting vs carotid endarterectomy. Stroke 2001;32:325.
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References to ongoing studies

ACST‐2 {published data only}
    1. Asymptomatic Carotid Surgery Trial (ACST‐2) – a large, simple randomised trial to compare carotid endarterectomy versus carotid artery stenting to prevent stroke (complete trial protocol). www.acst.org.uk (last accessed July 2010).
    1. NCT00883402. Carotid endarterectomy versus carotid artery stenting in asymptomatic patients (ACST‐2). clinicaltrials.gov/ct2/show/NCT00883402 (first received 17 April 2009).
    1. Rudarakanchana N, Dialynas M, Halliday A. Asymptomatic Carotid Surgery Trial‐2 (ACST‐2): rationale for a randomised clinical trial comparing carotid endarterectomy with carotid artery stenting in patients with asymptomatic carotid artery stenosis. European Journal of Vascular and Endovascular Surgery 2009;38(2):239‐42. - PubMed
Agostoni 2005 {published data only}
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CREST‐2 {unpublished data only}
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