Carotid endarterectomy for symptomatic carotid stenosis

Saritphat Orrapin; Kittipan Rerkasem

doi:10.1002/14651858.CD001081.pub3

Cochrane Database of Systematic Reviews

Karotidna endarterektomija za liječenje simptomatske karotidne stenoze

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DOI:

https://doi.org/10.1002/14651858.CD001081.pub3 Copiar DOI

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Cochrane Database of Systematic Reviews

Versión publicada:

07 junio 2017see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Accidentes cerebrovasculares

Copyright:

Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Saritphat Orrapin

Division of Vascular and Endovascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), Pathumthani, Thailand
Kittipan Rerkasem

Correspondencia a: NCD Center, Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand

[email protected]

NCD Center of Excellence, Research Institute of Health Science, Chiang Mai University, Chiang Mai, Thailand

Contributions of authors

Saritphat Orrapin: designed the protocol, performed searches, selected studies for inclusion or exclusion, extracted data and updated the review.
Kittipan Rerkasem: selected studies for inclusion or exclusion, advised on the design of the protocol, updated the review, extracted data and locally co‐ordinated the update.

Sources of support

Internal sources

Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand, Other.

External sources

Thailand’s Office of The Commission of Higher Education, Thailand.

Professor Rerkasem was supported by the NCD Center of Excellence, under Thailand’s Office of The Commission of Higher Education.

Declarations of interest

Saritphat Orrapin: none known.
Kittipan Rerkasem: none known.

Acknowledgements

We thank Professor PM Rothwell, Dr CS Cinà, Dr CM Clase, Dr R Brian Hayes, Dr S Arworn, Dr S Orrapin, Dr T Reanpang, and Dr W Chongruksut for their contribution to previous versions of this review; Hazel Fraser and Joshua David Cheyne for providing us with references to relevant trials from the Cochrane Stroke Group Trials Register; Dr Eliasziw and Professor Warlow for their contribution in the subgroup analyses. This research project was supported by Chiang Mai University.

Version history

Published

Title

Stage

Authors

Version

2020 Sep 12

Carotid endarterectomy for symptomatic carotid stenosis

Review

Amaraporn Rerkasem, Saritphat Orrapin, Dominic PJ Howard, Kittipan Rerkasem

https://doi.org/10.1002/14651858.CD001081.pub4

2017 Jun 07

Carotid endarterectomy for symptomatic carotid stenosis

Review

Saritphat Orrapin, Kittipan Rerkasem

https://doi.org/10.1002/14651858.CD001081.pub3

2011 Apr 13

Carotid endarterectomy for symptomatic carotid stenosis

Review

Kittipan Rerkasem, Peter M Rothwell

https://doi.org/10.1002/14651858.CD001081.pub2

1999 Jul 26

Carotid endarterectomy for symptomatic carotid stenosis

Review

Claudio Cina, Catherine Clase, R. Brian Haynes

https://doi.org/10.1002/14651858.CD001081

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Aged; Female; Humans; Male;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Surgery versus no surgery, Outcome 1 Any stroke or operative death.

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Analysis 1.2

Comparison 1 Surgery versus no surgery, Outcome 2 Ipsilateral ischaemic stroke and any operative stroke or death.

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Analysis 1.3

Comparison 1 Surgery versus no surgery, Outcome 3 Disabling or fatal ipsilateral ischaemic or operative stroke and death.

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Analysis 2.1

Comparison 2 Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET), Outcome 1 Sex.

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Analysis 2.2

Comparison 2 Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET), Outcome 2 Age (years).

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Analysis 2.3

Comparison 2 Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET), Outcome 3 Time since last event (weeks).

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Summary of findings for the main comparison. Carotid endarterectomy for symptomatic carotid stenosis

Carotid endarterectomy for symptomatic carotid stenosis
Patients or population: people with carotid stenosis and recent transient ischaemic attacks (TIA) or minor ischaemic strokes in the territory of that artery Settings: in hospitals with carotid centres¹ Intervention: best medical therapy with carotid surgery^2,3 Comparison: best medical therapy without carotid surgery²
Outcomes	Illustrative comparative risks* (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Best medical treatment alone	Best medical treatment with carotid surgery
Any stroke or operative death	Near occlusion		RR 0.95 (0.59 to 1.53)	271 (2 studies)	++++ High⁴	None of these RCTs could be blinded for surgeons or patients due to the nature of the intervention.
	22 per 100	20 per 100
	70% to 99% carotid stenosis		RR 0.53 (0.42 to 0.67)	1095 (3 studies)	+++Ο Moderate⁵
	29 per 100	15 per 100
	50% to 69% carotid stenosis		RR 0.77 (0.63 to 0.94)	1549 (3 studies)	+++Ο Moderate⁵
	23 per 100	18 per 100
	30% to 49% carotid stenosis		RR 0.97 (0.79 to 1.19)	1429 (2 studies)	++++ High⁴
	21 per 100	20 per 100
	< 30% carotid stenosis		RR 1.25 (0.99 ‐ 1.56)	1746 (2 studies)	++++ High⁴
	14 per 100	17 per 100
Ipsilateral ischaemic stroke, and any operative stroke or death	Near occlusion		RR 1.03 (0.57 to 1.84)	271 (2 studies)	++++ High⁴	None of these RCTs could be blinded for surgeons or patients due to the nature of the intervention.
	15 per 100	15 per 100
	70% to 99% carotid stenosis		RR 0.47 (0.25 to 0.88)	1095 (3 studies)	+++Ο Moderate⁵
	23 per 100	10 per 100
	50% to 69% carotid stenosis		RR 0.84 (0.60 to 1.18)	1549 (3 studies)	+++Ο Moderate⁵
	15 per 100	12 per 100
	30% to 49% carotid stenosis		RR 0.93 (0.62 to 1.38)	1429 (2 studies)	++++ High⁴
	15 per 100	13 per 100
	< 30% carotid stenosis		RR 1.27 (0.80 to 2.01)	1746 (2 studies)	++++ High⁴
	9 per 100	11 per 100
The basis for the assumed risk* is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the intervention group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio GRADE: GRADE Working Group grades of evidence (see explanations)
¹ ECST recruited from 100 centres in 14 European countries, NASCET from 106 centres mainly in the USA and Canada, but including some centres in Europe, Israel, South Africa and Australia, and the VACSP trial from 16 Veterans Affairs medical centres in the USA ² The recommended dose of aspirin for best medical treatment was 1300 mg in NASCET, 325 mg in the VACSP trial, and unspecified in ECST ³ The median time from randomisation to trial surgery was two days in the VACSP trial, three days in NASCET and 14 days in ECST. ⁴ All 2 studies (ECST, NASCET) are unconfounded truly randomised controlled trials and conducted on an intention to treat principle with adequate concealment, Few patients were lost to follow up in any of these studies (follow up 99.8‐100%) ⁵ All 3 studies (ECST, NASCET, VACSP) are unconfounded truly randomised controlled trials and conducted on an intention‐to‐treat principle. However, the allocation concealment was not described in one trial (VACSP). In addition, ECST and NASCET were both stopped after appropriately pre‐specified interim analyses showed that the trial stopping rules had been met. VACSP was also stopped with 193 participants after the results of ECST and NASCET were announced.

Summary of findings for the main comparison. Carotid endarterectomy for symptomatic carotid stenosis

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Table 1. The relationships between each subgroup variable and risk of each of the main elements of the primary outcome measure in medical arm.

Subgroups		Ipsilaterial ischaemic stroke in medical group
		HR	95% CI (‐)	P
Predefined patient subgroups
Sex (females versus males)		0.79	(0.64 to 0.97)	0.03
Age	< 65 years	1.00		0.001
	65 to 74 years	1.23	(1.00 to 1.51)
	75+ years	1.70	(1.28 to 2.56)
Time since last event	< 2 weeks	1.00		0.003
	2 to 4 weeks	0.80	(0.61 to 1.06)
	4 to 12 weeks	0.69	(0.55 to 0.88)
	> 12 weeks	0.61	(0.46 to 0.82)
Primary symptomatic event	Ocular only	1.00		< 0.001
	Cerebral TIA	1.88	(1.38 to 2.55)
	Stroke	2.33	(1.74 to 3.13)
Diabetes		1.31	(1.05 to 1.65)	0.02
Irregular/ulcerated plaque		1.35	(1.11 to 1.64)	0.003
Contralateral ICA occlusion		1.30	(0.09 to 1.88)	0.16
Post‐hoc patient subgroups
Duration of cerebral TIA	1 hour or less	1.00
Duration of cerebral TIA	> 1 hour	1.45	(1.03 to 2.04)	0.03
Previous TIA or stroke		1.20	(0.99 to 1.46)	0.07
Myocardial infarction		1.40	(1.11 to 1.77)	0.004
Angina		1.26	(1.02 to 1.56)	0.03
Treated hypertension		1.39	(1.15 to 1.68)	0.001
Treated hyperlipidaemia		0.78	(0.62 to 0.98)	0.03
Smoking		0.96	(0.80 to 1.16)	0.70
ICA: internal carotid artery TIA: transient ischaemic attack

Table 1. The relationships between each subgroup variable and risk of each of the main elements of the primary outcome measure in medical arm.

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Table 2. The relationships between each subgroup variable and risk of each of the main elements of the primary outcome measure in surgical arm

Subgroups		Perioperative stroke or death in surgery group
		HR	95% CI (‐)	P
Predefined patient subgroups
Sex (females versus males)		1.50	(1.14 to 1.97)	0.004
Age	< 65 years	1.00		0.78
	65 to 74 years	0.99	(0.76 to 1.32)
	75+ years	0.83	(0.49 to 1.41)
Time since last event	< 2 weeks	1.00		0.69
	2 to 4 weeks	1.22	(0.78 to 1.90)
	4 to 12 weeks	1.14	(0.77 to 1.68)
	> 12 weeks	1.28	(0.84 to 1.95)
Primary symptomatic event	Ocular only	1.00		< 0.001
	Cerebral TIA	2.62	(1.68 to 4.09)
	Stroke	1.91	(1.22 to 3.01)
Diabetes		1.45	(1.05 to 2.02)	0.03
Irregular/ulcerated plaque		1.37	(1.03 to 1.82)	0.03
Contralateral ICA occlusion		2.21	(1.33 to 3.67)	0.002
Post‐hoc patient subgroups
Duration of cerebral TIA	1 hour or less	1.00
Duration of cerebral TIA	> 1 hour	1.24	(0.81 to 1.92)	0.33
Previous TIA or stroke		1.59	(1.21 to 2.09)	0.001
Myocardial infarction		0.87	(0.59 to 1.27)	0.46
Angina		0.67	(0.47 to 0.97)	0.03
Treated hypertension		1.33	(1.02 to 1.74)	0.04
Treated hyperlipidaemia		1.06	(0.74 to 1.51)	0.75
Smoking		0.97	(0.74 to 1.27)	0.81
ICA: internal carotid artery TIA: transient ischaemic attack

Table 2. The relationships between each subgroup variable and risk of each of the main elements of the primary outcome measure in surgical arm

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Table 3. Significance of treatment‐effect modifiers for the relative treatment effect and absolute treatment effect for each of the subgroup variables

Effect of surgery on the risk of the primary outcome (P value)
	Relative risk reduction		Absolute reduction in 5‐year actuarial risk
	Cox model	5‐year actuarial risk
Predefined patient subgroups
Sex	0.007	0.008	0.003
Age groups	0.09 0.05 (trend)	0.04	0.03
Time since last event groups	0.04 0.006 (trend)	0.05	0.009
Primary symptomatic event	0.21	0.30	0.16
Diabetes	0.51	0.85	0.63
Irregular/ulcerated plaque	0.58	0.23	0.10
Contralateral ICA occlusion	0.30	0.34	0.25
Post‐hoc subgroups
Duration of cerebral TIA	0.44	0.47	0.42
Previous TIA or stroke	0.08	0.23	0.50
Myocardial infarction	0.06	0.02	0.01
Angina	0.08	0.11	0.06
Treated hypertension	0.19	0.29	0.09
Treated hyperlipidaemia	0.63	0.85	0.85
Smoking	0.40	0.40	0.38
ICA: internal carotid artery TIA: transient ischaemic attack

Table 3. Significance of treatment‐effect modifiers for the relative treatment effect and absolute treatment effect for each of the subgroup variables

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Comparison 1. Surgery versus no surgery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any stroke or operative death Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Near occlusion	2	271	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.59, 1.53]
1.2 70% to 99%	3	1095	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.42, 0.67]
1.3 50% to 69%	3	1549	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.63, 0.94]
1.4 30% to 49%	2	1429	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.79, 1.19]
1.5 < 30%	2	1746	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.99, 1.56]
2 Ipsilateral ischaemic stroke and any operative stroke or death Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Near occlusion	2	271	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.57, 1.84]
2.2 70% to 99%	3	1095	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.25, 0.88]
2.3 50% to 69%	3	1549	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.60, 1.18]
2.4 30% to 49%	2	1429	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.62, 1.38]
2.5 < 30%	2	1746	Risk Ratio (M‐H, Random, 95% CI)	1.27 [0.80, 2.01]
3 Disabling or fatal ipsilateral ischaemic or operative stroke and death Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 Near occlusion	2	271	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.51, 3.27]
3.2 70% to 99%	3	1095	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.26, 0.64]
3.3 50% to 69%	2	1502	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.46, 1.15]
3.4 30% to 49%	2	1429	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.60, 1.54]
3.5 < 30%	2	1746	Risk Ratio (M‐H, Fixed, 95% CI)	1.72 [0.99, 2.96]

Comparison 1. Surgery versus no surgery

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Comparison 2. Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sex Show forest plot	2		Risk Difference (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Men	2	1886	Risk Difference (M‐H, Fixed, 95% CI)	‐0.10 [‐0.13, ‐0.06]
1.2 Women	2	832	Risk Difference (M‐H, Fixed, 95% CI)	‐0.03 [‐0.07, 0.02]
2 Age (years) Show forest plot	2		Risk Difference (M‐H, Fixed, 95% CI)	Subtotals only

2.1 < 65	2	1281	Risk Difference (M‐H, Fixed, 95% CI)	‐0.05 [‐0.09, ‐0.01]
2.2 65 to 74	2	1143	Risk Difference (M‐H, Fixed, 95% CI)	‐0.07 [‐0.12, ‐0.03]
2.3 > 75	2	294	Risk Difference (M‐H, Fixed, 95% CI)	‐0.17 [‐0.26, ‐0.09]
3 Time since last event (weeks) Show forest plot	2		Risk Difference (M‐H, Fixed, 95% CI)	Subtotals only

3.1 < 2	2	624	Risk Difference (M‐H, Fixed, 95% CI)	‐0.17 [‐0.24, ‐0.11]
3.2 2 to 4	2	483	Risk Difference (M‐H, Fixed, 95% CI)	‐0.09 [‐0.15, ‐0.02]
3.3 4 to 12	2	1058	Risk Difference (M‐H, Fixed, 95% CI)	‐0.05 [‐0.09, ‐0.01]
3.4 > 12	2	553	Risk Difference (M‐H, Fixed, 95% CI)	0.00 [‐0.06, 0.06]

Comparison 2. Subgroup analyses (5‐year cumulative risk of ipsilateral carotid ischaemic stroke, and any stroke or death within 30 days after surgery, according to 3 variables in patients with > 50% carotid stenosis in ECST and NASCET)

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Karotidna endarterektomija za liječenje simptomatske karotidne stenoze

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