Patch angioplasty versus primary closure for carotid endarterectomy

Kittipan Rerkasem; Peter M Rothwell

doi:10.1002/14651858.CD000160.pub3

Angioplastia con parche versus cierre primario para la endarterectomía carotídea

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References

References to studies included in this review

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excluded studies
additional references
other published versions

AbuRahma AF, Khan JH, Robinson PA, Saiedy S, Short YS, Boland JP, et al. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: perioperative (30 day) results. Journal of Vascular Surgery 1996;24:998‐1007.

AbuRahma AF, Robinson PA, Saiedy S, Kahn JH, Boland JP. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: long‐term follow‐up. Journal of Vascular Surgery 1998;27(2):222‐32.

Al‐Rawi PG, Turner CL, Waran V, Ng I, Kirkpatrick PJ. A randomized trial of synthetic patch versus direct primary closure in carotid endarterectomy. Neurosurgery 2006;59:822‐29.

Eikelboom BC, Ackerstaff RGA, Hoeneveld H, Ludwig JW, Teeuwen C, Vermeulen FEE, et al. Benefits of carotid patching: a randomized study. Journal of Vascular Surgery 1988;7:240‐7.

de Letter JAM, Moll FL, Welten RJT, Eikelboom BC, Ackerstaff RGA, Vermeulen FEE, et al. Benefits of carotid patching: a prospective randomized study with long‐term follow‐up. Annals of Vascular Surgery 1994;8:54‐8.

Katz D, Snyder SO, Gandhi RH, Wheeler JR, Gregory RT, Gayle RG, et al. Long‐term follow up for recurrent stenosis: a prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy. Journal of Vascular Surgery 1994;19:198‐205.

Lord RSA, Raj TB, Stary DL, Nash PA, Graham AR, Goh KH. Comparison of saphenous vein patch, polytetrafluoroethylene patch, and direct arteriotomy closure after carotid endarterectomy. Part I: Perioperative results. Journal of Vascular Surgery 1989;9:521‐9.

Mannheim D, Weller B, Vahadim E, Karmeli R. Carotid endarterectomy with a polyurethane patch versus primary closure: a prospective randomized study. Journal of Vascular Surgery 2005;41:403‐8.

Clagett GP, Patterson CB, Fisher Jr DF, Fry RE, Eidt JF, Humble TH, et al. Vein patch versus primary closure for carotid endarterectomy. A randomized prospective study in a selected group of patients. Journal of Vascular Surgery 1989;9:213‐23.

Myers SI, Valentine RJ, Chervu A, Bowers BL, Clagett GP. Saphenous vein patch versus primary closure for carotid endarterectomy: long term assessment of a randomized prospective study. Journal of Vascular Surgery 1994;19:15‐22.

Pratesi C, Frullini A, Rega L, Fonda C, Matticari S, Alessi Innocenta A, et al. The follow‐up after carotid TEA. In: Maurer PC, Becker HM, Heidrich H, Hoffmann G, Kriessmann A, Muller‐Wiefel H, Pratorius C editor(s). Trends and Controversies. Vol. 1, Munich: W Zuckschwerdt, 1986:313‐5.

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De Vleeschauwer P, Wirthle W, Holler L, Krause E, Horsch S. Is venous patch grafting after carotid endarterectomy able to reduce the rate of restenosis? Prospective randomized pilot study with stratification. Acta Chirurgica Belgica 1987;87:242‐6.

References to studies excluded from this review

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included studies
additional references
other published versions

Gale S. Carotid endarterectomy with and without vein patch: a prospective randomized study. Journal of Vascular Surgery 1988;7:240‐7.

Hertzer NR, Beven EG, O'Hara PJ, Krajewski LP. A prospective study of vein patch angioplasty during carotid endarterectomy. Three‐year results for 801 patients and 917 operations. Annals of Surgery 1987;206:628‐35.

Additional references

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excluded studies
other published versions

Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA 1995;273(18):1421‐8.

Antiplatelet Trialists' Collaboration. Collaborative overview of trials of antiplatelet therapy ‐ I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ 1994;308:81‐106.

Awad IA, Little JR. Patch angioplasty in carotid endarterectomy. Advantages, concerns, and controversies. Stroke 1989;20:417‐22.

Bernstein EF, Torem S, Dilley RB. Does carotid restenosis predict an increased risk of late symptoms, stroke or death?. Annals of Surgery 1990;212:629‐36.

Bernstein EF. Routine versus selective carotid patching. Journal of Vascular Surgery 1992;15:868‐9.

Bond R, Rerkasem K, Naylor AR, Rothwell PM. Patches of different types for carotid patch angioplasty. Cochrane Database of Systematic Reviews 2004, Issue 2. [Art. No.: CD000071. DOI: 10.1002/14651858.CD000071]

Das MB, Hertzer NR, Ratliff NB, O'Hara PJ, Beven EG. Recurrent carotid stenosis. A five‐year series of 65 reports. Annals of Surgery 1985;202:28‐35.

European Carotid Surgery Trialists' Collaborative Group. MRC European Carotid Surgery Trial: Interim results for symptomatic patients with severe (70‐99%) or with mild (0‐29%) carotid stenosis. Lancet 1991;337:1235‐43.

Frericks H, Kievit J, van Baalen JM, van Bockel JH. Carotid recurrent stenosis and risk of ipsilateral stroke: a systematic review of the literature. Stroke 1998;29:244‐50.

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Golledge J, Cuming R, Davies AH, Greenhalgh RM. Outcome of selective patching following carotid endarterectomy. European Journal of Vascular and Endovascular Surgery 1996;11:458‐63.

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Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327:557‐60.

Knudsen L, Sillesen H, Schroeder T, Hansen HJB. Eight to ten years follow‐up after carotid endarterectomy: clinical evaluation and doppler examination of patients operated on between 1978‐1980. European Journal of Vascular Surgery 1990;4:259‐64.

Ouriel K, Green RM. Clinical and technical factors influencing recurrent carotid stenosis and occlusion after endarterectomy. Journal of Vascular Surgery 1987;5:702‐6.

Rerkasem K, Rothwell PM. Temporal trends in the risks of stroke and death due to endarterectomy for symptomatic carotid stenosis: an updated systematic review. European Journal of Vascular and Endovascular Surgery 2009;37:504‐11.

Rothwell P, Warlow C. Is self‐audit reliable?. Lancet 1995;346:1623.

Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, et al. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet 2003;361:107‐16.

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408‐12.

Volteas N, Labropoulos N, Leon M, Kalodiki E, Chan P, Nicolaides AN. Risk factors associated with recurrent carotid stenosis. International Angiology 1994;13:143‐7.

Zierler RE, Bandyk DF, Thiele BL, Strandness Jr DE. Carotid artery stenosis following endarterectomy. Archives of Surgery 1982;117:1408‐15.

References to other published versions of this review

Jump to:

included studies
excluded studies
additional references

Bond R, Rerkasem K, AbuRahma AF, Naylor AR, Rothwell PM. Patch angioplasty versus primary closure for carotid endarterectomy. Cochrane Database of Systematic Reviews 2004, Issue 2. [Art. No.: CD000160. DOI: 10.1002/14651858.CD000160.pub2]

Counsell C, Salinas R, Warlow C, Naylor R. Patch angioplasty versus primary closure for carotid endarterectomy. Cochrane Database of Systematic Reviews 1996, Issue 1. [Art. No.: CD000160. DOI: 10.1002/14651858.CD000160]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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excluded studies

AbuRahma 1996

Methods	R = computer‐generated sealed envelopes (artery randomised) Both duplex and clinical FU blinded Crossovers: 4 patients in vein group underwent primary closure and were excluded from the trial; 3 jugular vein patients had saphenous vein and were included in trial
Participants	USA 357 patients, 399 operations in three arms: 130 vein, 134 PTFE and 135 primary closure 50% male Mean age: 68 years 33% asymptomatic Comparability: age, sex, vascular risk factors, % asymptomatic disease similar in each group
Interventions	Rx: polytetrafluoroethylene patch or alternating saphenous vein patch (from ankle) and jugular vein Control: primary closure Routine shunting for all and GA 325 mg daily aspirin was started within 24 hours of surgery for all patients
Outcomes	Death, ipsilateral stroke, ipsilateral TIA and ipsilateral RIND at 30 days and 48 months Duplex evidence of restenosis > 50% during follow up
Notes	Ex: patients with ICA < 4 mm or combined CABG or redo surgery FU: mean 30 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Al‐Rawi 2006

Methods	R = envelope Duplex blind, clinical FU not blind Crossovers: unknown Indication for shunt in any sign of ischaemia from transcranial Doppler, cerebral function monitor, near infrared spectrscopy, Doppler flowmetry Exclusion during trial: none Patients lost to FU: 7 patch, 8 no patch
Participants	England 321 patients 338 operations 68% male Mean age: 69 years 10% asymptomatic carotid disease % stenosis unknown Comparability: age, sex, vascular risk factors, % asymptomatic disease were similar in each group
Interventions	Rx: collagen‐coated polyester vascular patch Control: primary closure % shunted: unknown After surgery, all patients were given rectal aspirin (600 mg)
Outcomes	Deaths < 30 days and end of FU Strokes < 30 days and end of FU Perioperative occlusion Bleeding or evacuation clot Cardiac event Restenosis > 50% or occlusion at end of FU (ultrasound)
Notes	Ex: 10 patients due to: poor cerebral blood flow (3 patients), ST depression (1 patient), high tortuosity (6 patients) FU: 12 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	C ‐ Inadequate

Eikelboom 1988

Methods	R = odd/even hospital number (patients randomised) Duplex blind, clinical FU not blind Crossovers: 3 primary closure to patch, 3 patch to primary closure (all analysed in original group) Exclusion during trial: none Patients lost to FU: 10 patch, 7 no patch
Participants	The Netherlands 126 patients 129 operations 73% male Mean age: 63 years 18% asymptomatic carotid disease All arteries > 60% stenosis Comparability: age, sex, vascular risk factors, % asymptomatic disease were similar in each group
Interventions	Rx: saphenous vein patch Control: primary closure 20% shunted Postoperative warfarin +/‐ antiplatelet for all
Outcomes	Deaths < 30 days and end of FU Strokes < 30 days and end of FU Perioperative occlusion (intravenous DSA) Wound haemorrhage Restenosis > 50% or occlusion at end of FU (Duplex and intravenous DSA)
Notes	Ex: simultaneous cardiac surgery FU: mean 5 years
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	High risk	C ‐ Inadequate

Katz 1994

Methods	R = odd/even social security number (patients randomised) Neither duplex nor clinical FU blind Crossovers: none Exclusions during trial: none Patients lost to FU: 12 in total
Participants	USA 87 patients 100 operations 56% male Mean age: 67 years 40% asymptomatic carotid disease Comparability: age, sex, vascular risk factors, % asymptomatic disease were similar in each group
Interventions	Rx: polytetrafluoroethylene patch Control: primary closure Routine shunting for all Postoperative aspirin (325 mg) for all
Outcomes	Death < 30 days and end of FU Stroke < 30 days and end of FU Perioperative occlusion (Duplex) Wound haemorrhage, infection, cranial nerve palsy Restenosis > 50% or occlusion at end of FU (Duplex)
Notes	Ex: previous endarterectomy, simultaneous cardiac surgery, internal carotid artery diameter < 3.5 mm FU: mean 29 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	High risk	C ‐ Inadequate

Lord 1989

Methods	R = sealed envelopes (artery randomised) Probably neither duplex nor clinical FU blind Crossovers: 4 (unclear which group these were in) Exclusions during trial: 4 crossovers Patients lost to FU: none
Participants	Australia 123 patients 140 operations. 62% male Mean age: 63 years % asymptomatic carotid disease unknown Comparability: age, sex, vascular risk factors, % symptomatic disease similar in each group
Interventions	Rx: saphenous vein patch or polytetrafluoroethylene patch (random allocation) Control: primary closure 17% shunted Postoperative aspirin for all
Outcomes	Ipsilateral stroke < 30 days Perioperative occlusion (intravenous DSA) Wound haemorrhage
Notes	Ex: unknown FU: until hospital discharge
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Mannheim 2005

Methods	R = sealed envelopes Duplex and clinical FU unknown for blinding Crossovers: none Exclusions during trial: none Patients lost to FU: unknown
Participants	Israel 404 patients 422 operations 65.6% male Mean age: 69.5 years 53.7% asymptomatic carotid disease Comparability: sex, vascular risk factors, % asymptomatic disease similar in each group
Interventions	Rx: polyester urethane patch angioplasty Control: primary closure Indication shunt for change in neurological status during carotid clamping or in patients in general anesthesia with stump pressure < 40 mmHg Peri and postoperative aspirin: unknown
Outcomes	Death < 30 days and end of FU Stroke < 30 days and end of FU Coronary event Wound haemorrhage, infection, cranial nerve palsy Restenosis > 50% or occlusion at end of FU (Duplex)
Notes	Ex: small ICA or need for interposition graft FU: 5 years
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	C ‐ Inadequate

Myers 1994

Methods	R = opaque, sequentially numbered sealed envelopes (artery randomised) Duplex blind, clinical FU not blind Crossovers: none Exclusions during trial: none Patients lost to FU: 6 patch, 8 no patch
Participants	USA 136 (109) patients 152 (126) operations 99% male Mean age: 62 years 23% asymptomatic carotid disease Comparability: age, sex, vascular risk factors, % asymptomatic disease similar in each group
Interventions	Rx: saphenous vein patch Control: primary closure Routine shunt for all Peri and postoperative aspirin (325 mg) for all
Outcomes	Death < 30 days and end of FU Stroke < 30 days and end of FU Perioperative occlusion (ocular pneumoplethysmography) Wound haemorrhage, infection, cranial nerve palsy Restenosis > 50% or occlusion at end of FU (Duplex)
Notes	Ex: ICA diameter < 5mm, arteriotomy > 3 cm, looped or kinked ICA FU: 4 to 5 years
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Pratesi 1986

Methods	R = unknown Duplex and clinical FU: unknown Crossovers: unknown Exclusions during trial: unknown Patients lost to FU: unknown
Participants	Italy 90 patients 100 operations Ratio: male:female 6:5 Mean age: unknown 10% asymptomatic carotid disease % stenosis: unknown Comparability: age, sex, vascular risk factors not reported by treatment group
Interventions	Rx: % autologous vein or synthetic (unknown) Control: primary closure Shunt: unknown indication Aspirin before surgery, unknown after surgery
Outcomes	Death < 30 days and FU period Stroke < 30 days and FU period Restenosis FU period (by DSA)
Notes	Ex: unknown FU: 2 years
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	C ‐ Inadequate

Ranaboldo 1993

Methods	R = opaque, sequentially‐numbered, sealed envelopes (artery randomised) Duplex and clinical FU blind Crossovers: 4 primary closure to patch (all analysed in original group) Exclusions during trial: none Patients lost to FU: none
Participants	United Kingdom 199 patients 213 operations 69% male Mean age: 66 years 8% asymptomatic carotid disease 60% arteries > 75% stenosis Comparability: age, sex, vascular risk factors not reported by treatment group
Interventions	Rx: autologous vein (N = 53) or Dacron (N = 56) patches (non‐random allocation) Control: primary closure Shunt 'when technically possible' Aspirin before surgery, unknown after surgery
Outcomes	Death < 30 days and end of FU Stroke < 30 days and end of FU Perioperative occlusion (Duplex) Wound haemorrhage, infection Restenosis > 50% or occlusion at end of FU (Duplex)
Notes	Ex: unknown FU: 12 months
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Vleeschauwer 1987

Methods	R ‐ sealed envelopes (not opaque or numbered) Clinical and Duplex FU blind Crossovers: none Exclusions during trial: patients with residual stenosis/occlusion (number known) Patients lost to FU: none
Participants	Germany 126 patients 174 operations 60% male Mean age: 64 years 30% asymptomatic carotid disease Comparability: age, sex, vascular risk factors, % asymptomatic disease not reported by treatment group
Interventions	Rx: autologous vein patch Control: primary closure Routine shunting for all Postoperative aspirin (1 g) for all
Outcomes	Death < 30 days and end of FU Stroke < 30 days and end of FU Wound haemorrhage, infection Restensosis > 50% or occlusion at end of FU (Duplex)
Notes	Ex: Recurrent stenosis, kinked ICA FU: 1 year
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	High risk	C ‐ Inadequate

CABG: coronary artery bypass graft
DSA: digital subtraction angiography
Ex: exclusion criteria
FU: follow up
GA: general anaesthesia
ICA: internal carotid artery
R: concealment of allocation
RIND: reversible ischaemic neurological deficit
Rx: treatment
TIA: transient ischaemic attack

Characteristics of excluded studies [ordered by study ID]

Jump to:

included studies

Study	Reason for exclusion
Gale 1985	Randomised by flipping a coin Not intention‐to‐treat About 300 patients randomised to either vein patch or primary closure: 194 patients had the operation to which they were randomised, the remaining patients were randomised to 1 procedure but actually had the other procedure for some reason Results only available for the 194 patients who remained in the group to which they were originally allocated
Hertzer 1987	Non‐random comparison of patching performed by one surgeon and primary closure performed by other surgeons in the same institute (personal communication with Dr Hertzer)

Data and analyses

Open in table viewer

Comparison 1. Patch versus no patch: perioperative complications < 30 days

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any stroke: fatal and non‐fatal Show forest plot	8	1769	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.57 [0.31, 1.03]
Open in figure viewer Analysis 1.1 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 1 Any stroke: fatal and non‐fatal.
1.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.38 [0.08, 1.72]
1.2 Synthetic patch	3	837	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.23 [0.50, 3.07]
1.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.29 [0.11, 0.74]
2 Stroke‐related death Show forest plot	7	1441	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.47 [0.05, 4.56]
Open in figure viewer Analysis 1.2 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 2 Stroke‐related death.
2.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.91 [0.06, 14.73]
2.2 Synthetic patch	2	509	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.13 [0.00, 6.46]
3 Stroke ipsilateral to endarterectomy site Show forest plot	7	1201	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.31 [0.15, 0.63]
Open in figure viewer Analysis 1.3 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 3 Stroke ipsilateral to endarterectomy site.
3.1 Venous patch	3	349	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.39 [0.09, 1.75]
3.2 Synthetic patch	1	100	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.53 [0.05, 5.19]
3.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.27 [0.11, 0.62]
4 Death from all causes Show forest plot	9	1869	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.62 [0.18, 2.09]
Open in figure viewer Analysis 1.4 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 4 Death from all causes.
4.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.79 [0.18, 17.57]
4.2 Synthetic patch	3	837	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.14 [0.00, 7.15]
4.3 Synthetic or venous patch	3	686	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.48 [0.10, 2.24]
5 Any stroke or death Show forest plot	8	1769	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.58 [0.33, 1.01]
Open in figure viewer Analysis 1.5 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 5 Any stroke or death.
5.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.55 [0.13, 2.25]
5.2 Synthetic patch	3	837	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.10 [0.45, 2.69]
5.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.34 [0.15, 0.78]
6 Occlusion of the artery operated on Show forest plot	7	1435	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.18 [0.08, 0.41]
Open in figure viewer Analysis 1.6 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 6 Occlusion of the artery operated on.
6.1 Venous patch	2	255	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.12 [0.01, 1.99]
6.2 Synthetic patch	2	428	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.33 [0.06, 1.95]
6.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.16 [0.06, 0.42]
7 Rupture/haemorrhage of endarterectomy site Show forest plot	9	2031	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.24 [0.61, 2.54]
Open in figure viewer Analysis 1.7 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 7 Rupture/haemorrhage of endarterectomy site.
7.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	6.86 [0.14, 346.63]
7.2 Synthetic patch	3	850	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.92 [0.39, 2.14]
7.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.32 [0.56, 9.57]
8 Infection of the endarterectomy site Show forest plot	7	1563	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.38 [0.09, 1.54]
Open in figure viewer Analysis 1.8 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 8 Infection of the endarterectomy site.
8.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.2 Synthetic patch	2	522	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.38 [0.09, 1.54]
8.3 Synthetic or venous patch	2	612	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Cranial nerve palsy Show forest plot	4	1047	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.78 [0.36, 1.69]
Open in figure viewer Analysis 1.9 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 9 Cranial nerve palsy.
9.1 Venous patch	1	126	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.77 [0.17, 3.50]
9.2 Synthetic patch	2	522	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.75 [0.24, 2.35]
9.3 Synthetic or venous patch	1	399	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.85 [0.19, 3.71]
10 Complication with return to theatre Show forest plot	7	1281	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.35 [0.16, 0.79]
Open in figure viewer Analysis 1.10 Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 10 Complication with return to theatre.
10.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.98 [0.06, 15.64]
10.2 Synthetic patch	1	100	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.53 [0.05, 5.19]
10.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.29 [0.12, 0.73]

Open in table viewer

Comparison 2. Patch versus no patch: outcomes at end of follow up

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any stroke: fatal and non‐fatal Show forest plot	7	1332	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.49 [0.27, 0.90]
Open in figure viewer Analysis 2.1 Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 1 Any stroke: fatal and non‐fatal.
1.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.42 [0.14, 1.30]
1.2 Synthetic patch	2	400	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.95 [0.59, 6.45]
1.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.25 [0.10, 0.62]
2 Stroke‐related death Show forest plot	6	1019	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.27 [0.05, 1.60]
Open in figure viewer Analysis 2.2 Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 2 Stroke‐related death.
2.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.46 [0.05, 4.52]
2.2 Synthetic patch	1	87	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.13 [0.01, 2.04]
3 Stroke ipsilateral to endarterectomy site Show forest plot	6	1141	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.32 [0.16, 0.63]
Open in figure viewer Analysis 2.3 Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 3 Stroke ipsilateral to endarterectomy site.
3.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.42 [0.12, 1.47]
3.2 Synthetic patch	1	100	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.53 [0.05, 5.19]
3.3 Synthetic or venous patch	2	612	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.25 [0.10, 0.62]
4 Death from all causes Show forest plot	7	1332	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.78 [0.54, 1.12]
Open in figure viewer Analysis 2.4 Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 4 Death from all causes.
4.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.80 [0.45, 1.42]
4.2 Synthetic patch	2	400	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.90 [0.39, 2.05]
4.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.69 [0.38, 1.26]
5 Any stroke or death Show forest plot	6	1019	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.59 [0.42, 0.84]
Open in figure viewer Analysis 2.5 Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 5 Any stroke or death.
5.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.69 [0.40, 1.20]
5.2 Synthetic patch	1	87	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.62 [0.23, 1.66]
5.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.51 [0.30, 0.86]
6 Restenosis/occlusion of the operated artery Show forest plot	8	1719	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.24 [0.17, 0.34]
Open in figure viewer Analysis 2.6 Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 6 Restenosis/occlusion of the operated artery.
6.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.34 [0.17, 0.66]
6.2 Synthetic patch	3	678	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.46 [0.22, 0.98]
6.3 Synthetic or venous patch	2	612	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.15 [0.09, 0.25]

Analysis 1.1

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 1 Any stroke: fatal and non‐fatal.

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Analysis 1.2

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 2 Stroke‐related death.

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Analysis 1.3

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 3 Stroke ipsilateral to endarterectomy site.

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Analysis 1.4

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 4 Death from all causes.

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Analysis 1.5

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 5 Any stroke or death.

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Analysis 1.6

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 6 Occlusion of the artery operated on.

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Analysis 1.7

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 7 Rupture/haemorrhage of endarterectomy site.

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Analysis 1.8

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 8 Infection of the endarterectomy site.

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Analysis 1.9

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 9 Cranial nerve palsy.

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Analysis 1.10

Comparison 1 Patch versus no patch: perioperative complications < 30 days, Outcome 10 Complication with return to theatre.

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Analysis 2.1

Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 1 Any stroke: fatal and non‐fatal.

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Analysis 2.2

Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 2 Stroke‐related death.

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Analysis 2.3

Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 3 Stroke ipsilateral to endarterectomy site.

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Analysis 2.4

Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 4 Death from all causes.

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Analysis 2.5

Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 5 Any stroke or death.

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Analysis 2.6

Comparison 2 Patch versus no patch: outcomes at end of follow up, Outcome 6 Restenosis/occlusion of the operated artery.

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Table 1. Number of cases lost to follow up

Study	Total patients	Total operations	Patch lost at 30 days	Patch lost at end	Primary lost at 30 days	Primary lost at end	Number of exclusions	Crossover patch ‐ non	Crossover non ‐ patch
AbuRahma 1996	357	399	0	0	0	0	4	0	0
Al‐Rawi 2006l	315	338	0	7	0	8	10	Data not available	Data not available
Eikelboom 1988	126	129	0	10 patients lost to doppler FU but not clinical FU	0	7 to doppler FU but not clinical FU	0	3	3
Katz 1994	87	100	0	5	0	7	0	0	0
Lord 1989	123	140	0	0	0	0	4	Between 0 and 4	Between 0 and 4
Mannheim 2005	404	422	0	Data not available	0	Data not available	Data not available	0	0
Myers 1994	136 (109 after exclusion of 27 patients undergoing obligatory vein patching)	152 (122 analysed as 30 operations got obligatory vein patches)	0	6	0	8	30 operations underwent obligatory vein patch closure and 16 patients had both sides done (total 46)	0	0
Pratesi 1986	100	100	Data not available	Data not available	Data not available	Data not available	Data not available	Data not available	Data not available
Ranaboldo 1993	199	213	0	5	0	12	0	0	0 at 30‐day FU but 4 at 1‐year FU
Vleeschauwer 1987	126	174	0	Data not available	0	Data not available	0	0	0
FU: follow up

Table 1. Number of cases lost to follow up

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Comparison 1. Patch versus no patch: perioperative complications < 30 days

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any stroke: fatal and non‐fatal Show forest plot	8	1769	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.57 [0.31, 1.03]

1.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.38 [0.08, 1.72]
1.2 Synthetic patch	3	837	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.23 [0.50, 3.07]
1.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.29 [0.11, 0.74]
2 Stroke‐related death Show forest plot	7	1441	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.47 [0.05, 4.56]

2.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.91 [0.06, 14.73]
2.2 Synthetic patch	2	509	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.13 [0.00, 6.46]
3 Stroke ipsilateral to endarterectomy site Show forest plot	7	1201	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.31 [0.15, 0.63]

3.1 Venous patch	3	349	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.39 [0.09, 1.75]
3.2 Synthetic patch	1	100	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.53 [0.05, 5.19]
3.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.27 [0.11, 0.62]
4 Death from all causes Show forest plot	9	1869	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.62 [0.18, 2.09]

4.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.79 [0.18, 17.57]
4.2 Synthetic patch	3	837	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.14 [0.00, 7.15]
4.3 Synthetic or venous patch	3	686	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.48 [0.10, 2.24]
5 Any stroke or death Show forest plot	8	1769	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.58 [0.33, 1.01]

5.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.55 [0.13, 2.25]
5.2 Synthetic patch	3	837	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.10 [0.45, 2.69]
5.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.34 [0.15, 0.78]
6 Occlusion of the artery operated on Show forest plot	7	1435	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.18 [0.08, 0.41]

6.1 Venous patch	2	255	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.12 [0.01, 1.99]
6.2 Synthetic patch	2	428	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.33 [0.06, 1.95]
6.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.16 [0.06, 0.42]
7 Rupture/haemorrhage of endarterectomy site Show forest plot	9	2031	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.24 [0.61, 2.54]

7.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	6.86 [0.14, 346.63]
7.2 Synthetic patch	3	850	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.92 [0.39, 2.14]
7.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	2.32 [0.56, 9.57]
8 Infection of the endarterectomy site Show forest plot	7	1563	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.38 [0.09, 1.54]

8.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.2 Synthetic patch	2	522	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.38 [0.09, 1.54]
8.3 Synthetic or venous patch	2	612	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Cranial nerve palsy Show forest plot	4	1047	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.78 [0.36, 1.69]

9.1 Venous patch	1	126	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.77 [0.17, 3.50]
9.2 Synthetic patch	2	522	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.75 [0.24, 2.35]
9.3 Synthetic or venous patch	1	399	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.85 [0.19, 3.71]
10 Complication with return to theatre Show forest plot	7	1281	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.35 [0.16, 0.79]

10.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.98 [0.06, 15.64]
10.2 Synthetic patch	1	100	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.53 [0.05, 5.19]
10.3 Synthetic or venous patch	3	752	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.29 [0.12, 0.73]

Comparison 1. Patch versus no patch: perioperative complications < 30 days

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Comparison 2. Patch versus no patch: outcomes at end of follow up

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Any stroke: fatal and non‐fatal Show forest plot	7	1332	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.49 [0.27, 0.90]

1.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.42 [0.14, 1.30]
1.2 Synthetic patch	2	400	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.95 [0.59, 6.45]
1.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.25 [0.10, 0.62]
2 Stroke‐related death Show forest plot	6	1019	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.27 [0.05, 1.60]

2.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.46 [0.05, 4.52]
2.2 Synthetic patch	1	87	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.13 [0.01, 2.04]
3 Stroke ipsilateral to endarterectomy site Show forest plot	6	1141	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.32 [0.16, 0.63]

3.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.42 [0.12, 1.47]
3.2 Synthetic patch	1	100	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.53 [0.05, 5.19]
3.3 Synthetic or venous patch	2	612	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.25 [0.10, 0.62]
4 Death from all causes Show forest plot	7	1332	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.78 [0.54, 1.12]

4.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.80 [0.45, 1.42]
4.2 Synthetic patch	2	400	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.90 [0.39, 2.05]
4.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.69 [0.38, 1.26]
5 Any stroke or death Show forest plot	6	1019	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.59 [0.42, 0.84]

5.1 Venous patch	3	346	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.69 [0.40, 1.20]
5.2 Synthetic patch	1	87	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.62 [0.23, 1.66]
5.3 Synthetic or venous patch	2	586	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.51 [0.30, 0.86]
6 Restenosis/occlusion of the operated artery Show forest plot	8	1719	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.24 [0.17, 0.34]

6.1 Venous patch	3	429	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.34 [0.17, 0.66]
6.2 Synthetic patch	3	678	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.46 [0.22, 0.98]
6.3 Synthetic or venous patch	2	612	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.15 [0.09, 0.25]

Comparison 2. Patch versus no patch: outcomes at end of follow up

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References

References to studies included in this review

AbuRahma 1996 {published data only}

Al‐Rawi 2006 {published data only}

Eikelboom 1988 {published and unpublished data}

Katz 1994 {published and unpublished data}

Lord 1989 {published and unpublished data}

Mannheim 2005 {published data only}

Myers 1994 {published and unpublished data}

Pratesi 1986 {published data only}

Ranaboldo 1993 {published and unpublished data}

Vleeschauwer 1987 {published and unpublished data}

References to studies excluded from this review

Gale 1985 {unpublished data only}

Hertzer 1987 {published and unpublished data}

Additional references

ACAS 1995

APT 1994

Awad 1989

Bernstein 1990

Bernstein 1992

Bond 2003

Das 1985

ECST 1991

Frericks 1998

Girn 2008

Golledge 1996

Halliday 2004

Higgins 2003

Knudsen 1990

Ouriel 1987

Rerkasem 2009

Rothwell 1995

Rothwell 2003

Schulz 1995

Volteas 1994

Zierler 1982

References to other published versions of this review

Bond 2004

Counsell 1996

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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