Key messages
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During an operation to widen one or both of the main blood vessels of the neck (carotid endarterectomy), there is probably little or no difference between the use of man-made (synthetic) and natural (biological) patches to close the repair in terms of the risk of stroke or death up to 80 months after the operation. There may be little or no difference between the patches in the risk of stroke on one side of the body (ipsilateral stroke), stroke of any type, or the blood vessel being blocked or narrowing again by more than half its width (arterial occlusion or re-stenosis greater than 50%) up to 80 months after the operation.
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The evidence is very uncertain about the effect of synthetic compared with biological patches on the risk of a stroke on one side of the body or a rupture of the artery (bleeding from the patch repair) during the operation or within 30 days, or a leak from artery repair causing a small blood-filled bulge (pseudoaneurysm formation) up to 80 months after the operation.
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Larger studies with longer follow-up are needed so that we can know for sure whether synthetic and biological patches have similar results, or whether one type is safer or more effective than the other.
What is carotid endarterectomy?
Carotid endarterectomy is an operation to remove fatty build-up from one or both of the main blood vessels (carotid arteries) in the neck. Fatty build-up can narrow the artery or block blood flow to the brain, causing a stroke. Removing it helps reduce this risk. After the artery is opened and cleaned, surgeons often sew in a patch to widen the artery and strengthen the repair.
What patches are used in carotid endarterectomy?
Patches can be made from natural (biological) materials, such as a vein from the patient's own body (autologous vein) or tissue from a cow's heart (bovine pericardium), or from man-made (synthetic) materials, such as PTFE (polytetrafluoroethylene) or Dacron. Different patch materials may affect healing and the risk of infection, blood clots, or the artery narrowing again. These problems may increase the risk of stroke.
What did we want to find out?
We wanted to find out whether the choice of patch material affects the results of surgery, especially the risks of stroke, artery-related complications, and death, and longer-term effects.
What did we do?
We searched for studies that compared different patch materials in people undergoing carotid endarterectomy. We combined patches made using human veins or bovine pericardium into one category (biological patches), and all man-made materials into another category (synthetic patches). We compared and summarised the results of the studies, and rated our confidence in the evidence, based on factors such as study methods and sizes.
What did we find?
From our updated searches, we identified one new study, as well as some long-term results from studies included in previous versions of the review. In total, the review includes 15 studies involving 4971 participants, mainly men in their sixties. The studies were conducted in North America, Europe, and Australia.
Main results
Twelve studies (with 2021 carotid endarterectomy procedures) contributed results to our main comparison of synthetic and biological patches.
The evidence is very uncertain about the effects of synthetic versus biological patches on:
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stroke on one side of the body during the operation or within 30 days (5 studies, 797 participants);
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a rupture of the artery during the operation or within 30 days (6 studies, 1068 participants);
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a leak from artery repair causing a small blood-filled bulge up to 80 months after the operation (5 studies, 980 participants).
The use of synthetic patches instead of biological patches may result in little or no difference in:
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stroke on one side of the body up to 53 months after the operation (5 studies, 971 participants);
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stroke of any type up to 53 months after the operation (7 studies, 1167 participants);
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blocking of the artery or narrowing again by more than half the width up to 80 months after the operation (9 studies, 1431 participants).
The use of synthetic patches instead of biological patches probably results in little or no difference in:
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stroke or death up to 80 months after the operation (6 studies, 1115 participants).
What are the limitations of the evidence?
We do not know for sure if synthetic and biological patches give similar results for people undergoing carotid endarterectomy, or if one type works better or is safer than the other. We are uncertain because:
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many of the studies were small;
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there were problems with how some studies were carried out and how they reported their results;
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some important complications were rare, which makes it difficult to detect any difference in risk between patch types.
How up to date is the evidence?
This is an update of a review originally published 30 years ago and last updated in 2021. The evidence is current to 30 April 2025.
Читать полную аннотацию (абстракт)
Extracranial carotid artery stenosis is the major cause of stroke, which can lead to disability and mortality. Carotid endarterectomy (CEA) with carotid patch angioplasty is the most popular technique for reducing the risk of stroke. Patch material may be made from an autologous vein, bovine pericardium, or synthetic material including polytetrafluoroethylene (PTFE), Dacron, polyurethane, and polyester. This is an update of a review that was first published in 1996 and was last updated in 2010.
Задачи
To assess the benefits and harms of synthetic patch materials and biological patch materials (autologous vein and bovine pericardium) used in carotid endarterectomy, particularly for pseudoaneurysm outcomes, stroke, and death.
Методы поиска
To identify studies for inclusion in this updated Cochrane review, we searched Embase Ovid, CINAHL (EBSCO), PubMed, Scopus, the Cochrane Library, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) to 30 April 2025. We also searched reference lists of relevant articles and conference proceedings.
Критерии отбора
Randomised and quasi-randomised trials (RCTs) comparing one type of carotid patch with another for CEA.
Сбор и анализ данных
Two review authors independently assessed eligibility, risk of bias, and trial quality; extracted data; and determined the quality of evidence using the GRADE approach. Outcomes, for example, perioperative ipsilateral stroke and long-term ipsilateral stroke (at least one year), were collected and analysed.
Основные результаты
We included 14 trials involving a total of 2278 CEAs with patch closure operations: seven trials compared vein closure with PTFE closure, five compared Dacron grafts with other synthetic materials, and two compared bovine pericardium with other synthetic materials. In most trials, a patient could be randomised twice and could have each carotid artery randomised to different treatment groups.
Synthetic patch compared with vein patch angioplasty
Vein patch may have little to no difference in effect on perioperative ipsilateral stroke between synthetic versus vein materials, but the evidence is very uncertain (odds ratio (OR) 2.05, 95% confidence interval (CI) 0.66 to 6.38; 5 studies, 797 participants; very low-quality evidence). Vein patch may have little to no difference in effect on long-term ipsilateral stroke between synthetic versus vein materials, but the evidence is very uncertain (OR 1.45, 95% CI 0.69 to 3.07; P = 0.33; 4 studies, 776 participants; very low-quality evidence). Vein patch may increase pseudoaneurysm formation when compared with synthetic patch, but the evidence is very uncertain (OR 0.09, 95% CI 0.02 to 0.49; 4 studies, 776 participants; very low-quality evidence). However, the numbers involved were small.
Dacron patch compared with other synthetic patch angioplasty
Dacron versus PTFE patch materials
PTFE patch may reduce the risk of perioperative ipsilateral stroke (OR 3.35, 95% CI 0.19 to 59.06; 2 studies, 400 participants; very low-quality evidence). PTFE patch may reduce the risk of long-term ipsilateral stroke (OR 1.52, 95% CI 0.25 to 9.27; 1 study, 200 participants; very low-quality evidence). Dacron may result in an increase in perioperative combined stroke and transient ischaemic attack (TIA) (OR 4.41 95% CI 1.20 to 16.14; 1 study, 200 participants; low-quality evidence) when compared with PTFE. Early arterial re-stenosis or occlusion (within 30 days) was also higher for Dacron patches. During follow-up for longer than one year, more 'any strokes' (OR 10.58, 95% CI 1.34 to 83.43; 2 studies, 304 participants; low-quality evidence) and stroke/death (OR 6.06, 95% CI 1.31 to 28.07; 1 study, 200 participants; low-quality evidence) were reported with Dacron patch closure, although numbers of outcome events were small. Dacron patch may increase the risk of re-stenosis when compared with other synthetic materials (especially with PTFE), but the evidence is very uncertain (OR 3.73, 95% CI 0.71 to 19.65; 3 studies, 490 participants; low-quality evidence).
Bovine pericardium patch compared with other synthetic patch angioplasty
Bovine pericardium versus PTFE patch materials
Evidence suggests that bovine pericardium patch results in a reduction in long-term ipsilateral stroke (OR 4.17, 95% CI 0.46 to 38.02; 1 study, 195 participants; low-quality evidence). Bovine pericardial patch may reduce the risk of perioperative fatal stroke, death, and infection compared to synthetic material (OR 5.16, 95% CI 0.24 to 108.83; 2 studies, 290 participants; low-quality evidence for PTFE, and low-quality evidence for Dacron; OR 4.39, 95% CI 0.48 to 39.95; 2 studies, 290 participants; low-quality evidence for PTFE, and low-quality evidence for Dacron; OR 7.30, 95% CI 0.37 to 143.16; 1 study, 195 participants; low-quality evidence, respectively), but the numbers of outcomes were small. The evidence is very uncertain about effects of the patch on infection outcomes.
Выводы авторов
This 2026 updated review incorporates an expanded search strategy and a restructured analytical framework that groups patch materials into biological and synthetic categories. It also includes data from one newly identified trial (195 participants), together with extended follow-up data for some previously included trials. We believe that these changes have improved the completeness and methodological quality of our evidence synthesis.
The available evidence suggests that the use of synthetic patches after carotid endarterectomy may result in little or no difference in long-term ipsilateral stroke and stroke of any type compared to the use of biological patches. Synthetic patches may result in little or no difference in long-term arterial occlusion or re-stenosis greater than 50% compared to biological patches, and probably result in little or no difference in long-term stroke or death. The evidence is very uncertain about the effect of synthetic compared with biological patches on perioperative ipsilateral stroke, perioperative arterial rupture, and long-term pseudoaneurysm formation. Most findings were affected by study design limitations and imprecision. Large, high-quality trials are needed to confirm or clarify these findings.
Финансирование
None
Регистрация
DOIs of previous review versions: https://doi.org/10.1002/14651858.CD000071; https://doi.org/10.1002/14651858.CD000071.pub2; https://doi.org/10.1002/14651858.CD000071.pub3; https://doi.org/10.1002/14651858.CD000071.pub4
