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Peter M Rothwell - One of the best experts on this subject based on the ideXlab platform.
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systematic review of randomized controlled trials of Patch Angioplasty versus primary closure and different types of Patch materials during carotid endarterectomy
Asian Journal of Surgery, 2011Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:Objective Patch Angioplasty during carotid endarterectomy (CEA) can reduce the risk of perioperative stroke or late carotid artery recurrent stenosis and subsequent ischaemic stroke. We aimed to update our previous systematic review of randomized controlled trials (RCTs) of routine or selective carotid Patch Angioplasty compared with CEA with primary closure, and of different materials used for carotid Patch Angioplasty. Methods We identified new RCTs published during 2002-2010 by searching Medline, Embase and the Cochrane Stroke Group Trials Register. We also hand-searched six relevant journals. Pooled estimates of treatment effects combined with our previous review (1966-2001) were calculated on the basis of a weighted estimate of the odds ratio (OR) with the Peto method. Results Twenty-three eligible RCTs were identified in both periods. Ten RCTs involving 2,157 operations compared primary closure with routine Patch closure. Patch closure significantly reduced the combined risk of perioperative stroke and later stroke during long-term follow-up [OR = 0.49, 95% confidence interval (CI) = 0.27-0.90, p = 0.001; 7 RCTs]. Patching also reduced the risks of perioperative arterial occlusion (OR = 0.18, 95% CI=0.08-0.41, p p Conclusion Meta-analysis of relatively small RCTs suggests that carotid Patch Angioplasty reduces the combined perioperative and long-term risk of stroke and the risk of restenosis. More data are needed.
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Patches of different types for carotid Patch Angioplasty
Cochrane Database of Systematic Reviews, 2010Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:Background 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. Objectives To assess the safety and efficacy of different types of Patch materials used in carotid Patch Angioplasty. The primary hypothesis was that a synthetic material was associated with lower risk of Patch rupture versus venous Patches, but that venous Patches were associated with lower risk of perioperative stroke and early or late infection, or both. Search methods We searched the Cochrane Stroke Group trials register (last searched 25 May 2020); the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4), in the Cochrane Library; MEDLINE (1966 to 25 May 2020); Embase (1980 to 25 May 2020); the Index to Scientific and Technical Proceedings (1980 to 2019); the Web of Science Core Collection; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal. We handsearched relevant journals and conference proceedings, checked reference lists, and contacted experts in the field. Selection criteria Randomised and quasi-randomised trials (RCTs) comparing one type of carotid Patch with another for CEA. Data collection and analysis 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. Main results 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. Authors' conclusions The number of outcome events is too small to allow conclusions, and more trial data are required to establish whether any differences do exist. Nevertheless, there is little to no difference in effect on perioperative and long-term ipsilateral stroke between vein and any synthetic Patch material. Some evidence indicates that other synthetic Patches (e.g. PTFE) may be superior to Dacron grafts in terms of perioperative stroke and TIA rates, and both early and late arterial re-stenosis and occlusion. Pseudoaneurysm formation may be more common after use of a vein Patch than after use of a synthetic Patch. Bovine pericardial Patch, which is an acellular xenograft material, may reduce the risk of perioperative fatal stroke, death, and infection compared to other synthetic Patches. Further large RCTs are required before definitive conclusions can be reached.
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Patch Angioplasty versus primary closure for carotid endarterectomy
Cochrane Database of Systematic Reviews, 2009Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:BACKGROUND Carotid Patch Angioplasty (with either a venous or a synthetic Patch) may reduce the risk of carotid artery restenosis and subsequent ischaemic stroke. OBJECTIVES The objective of this review was to assess the safety and efficacy of routine or selective carotid Patch Angioplasty compared to carotid endarterectomy with primary closure. SEARCH STRATEGY We searched the Cochrane Stroke Group Trials Register (last searched November 2002). In addition, we searched the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), MEDLINE (1966 to December 2001), EMBASE (1980 to December 2001) and Index to Scientific and Technical Proceedings (1980 to 2001). We also handsearched eight journals and five conference proceedings. Reference lists were checked and we contacted experts in the field to identify further published and unpublished studies. SELECTION CRITERIA Randomised and quasi-randomised trials comparing carotid Patch Angioplasty with primary closure in any patients undergoing carotid endarterectomy. DATA COLLECTION AND ANALYSIS Two reviewers independently assessed eligibility, trial quality and extracted the data. MAIN RESULTS The previous review included six trials involving 794 patients undergoing 882 operations. Since the last review only one study of adequate quality to be included has been reported. This added 399 operations randomised to either primary closure, vein Patch or synthetic Patch groups resulting in 1127 patients undergoing 1307 operations being available for analysis. The quality of trials was generally poor. Follow-up varied from hospital discharge to five years. Carotid Patch Angioplasty was associated with a reduction in the risk of stroke of any type (OR = 0.33, p = 0.004), ipsilateral stroke (OR = 0.31, p = 0.0008), and stroke or death, during the perioperative period (OR = 0.39, p = 0.007) and long term follow-up (OR = 0.59, p = 0.004). It was also associated with a reduced risk of perioperative arterial occlusion (odds ratio 0.15, 95% confidence interval 0.06 to 0.37 p = 0.00004), and decreased restenosis during long-term follow-up in five trials, (odds ratio 0.20, 95% confidence interval 0.13 to 0.29 p < 0.00001). These results are more certain than those of the previous review since the number of operations and events have increased. However, the sample sizes are still relatively small, data were not available from all trials, and there was significant loss to follow-up. Very few arterial complications, including haemorrhage, infection, cranial nerve palsies and pseudo-aneurysm formation were recorded with either Patch or primary closure. No significant correlation was found between use of Patch Angioplasty and the risk of either perioperative or long-term all-cause death rates REVIEWERS' CONCLUSIONS Limited evidence suggests that carotid Patch Angioplasty may reduce the risk of perioperative arterial occlusion and restenosis. It would appear to reduce the risk of combined death or stroke and there is a non significant trend towards a reduction in all-cause mortality.
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systematic review of randomized controlled trials of Patch Angioplasty versus primary closure during carotid endarterectomy
Stroke, 2005Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:Section Editors: Geoffrey A. Donnan MD, FRACP Stephen M. Davis MD, FRACP Carotid endarterectomy has been shown to reduce the risk of stroke in selected patients with internal carotid artery stenosis. Carotid Patch Angioplasty performed during surgery may reduce the risk of restenosis, and consequently reduce the long-term risk of recurrent stroke. However, Patching itself may be associated with complications. We tested the hypothesis that carotid Patch Angioplasty resulted in a lower rate of significant arterial re-stenosis and therefore fewer recurrent strokes and stroke-related deaths without an increase in perioperative complications. Two reviewers independently searched MEDLINE (1996 to April 2003), EMBASE (1980 to 2002), and Index to Scientific and Technical Proceedings (1980 to 1994). We also searched the Stroke Group trials register (April 2003), hand-searched 13 relevant journals up to 2002, …
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systematic review of randomized controlled trials of Patch Angioplasty versus primary closure and different types of Patch materials during carotid endarterectomy
Journal of Vascular Surgery, 2004Co-Authors: R Bond, Kittipan Rerkasem, A R Naylor, Ali F Aburahma, Peter M RothwellAbstract:Background Patch Angioplasty during carotid endarterectomy (CEA) may reduce the risk for perioperative or late carotid artery recurrent stenosis and subsequent ischemic stroke. We performed a systematic review of randomized controlled trials to assess the effect of routine or selective carotid Patch Angioplasty compared with CEA with primary closure, and the effect of different materials used for carotid Patch Angioplasty. Methods Randomized trials were included if they compared carotid Patch Angioplasty with primary closure in any patients undergoing CEA or use of one type of carotid Patch with another. Results Thirteen eligible randomized trials were identified. Seven trials involving 1281 operations compared primary closure with routine Patch closure, and 8 trials with 1480 operations compared different Patch materials (2 studies compared both). Patch Angioplasty was associated with a reduction in risk for stroke of any type (P = .004), ipsilateral stroke (P = .001), and stroke or death during both the perioperative period (P = .007) and long-term follow-up (P = .004). Patching was also associated with reduced risk for perioperative arterial occlusion (P = .0001) and decreased recurrent stenosis during long-term follow-up (P Conclusions Carotid Patch Angioplasty decreases the risk for perioperative death or stroke, and long-term risk for ipsilateral ischemic stroke. More data are required to establish differences between various Patch materials.
G G Koning - One of the best experts on this subject based on the ideXlab platform.
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carotid endarterectomy with Patch Angioplasty versus primary closure in patients with symptomatic and significant stenosis a systematic review with meta analyses and trial sequential analysis of randomized clinical trials
Systematic Reviews, 2021Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Christian Gluud, Frans L Moll, Frederik Keus, G G KoningAbstract:Patch Angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques. Searches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with Patch Angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events. We included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with Patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with Patch Angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for Patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for Patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation. This systematic review showed no conclusive evidence of a difference between carotid endarterectomy with Patch Angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials Patch Angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200–7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned. PROSPERO CRD42014013416 . Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .
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eversion technique versus conventional endarterectomy with Patch Angioplasty in carotid surgery protocol for a systematic review with meta analyses and trial sequential analysis of randomised clinical trials
BMJ Open, 2020Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Frans L Moll, Frederik Keus, P W H E Vriens, Ronald L A W Bleys, G G KoningAbstract:Introduction Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of Patch Angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with Patch Angioplasty in patients with symptomatic carotid stenosis. Methods and outcomes The review will be conducted according to this protocol following the recommendations of the ‘Cochrane Handbook for Systematic Reviews’ and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with Patch Angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses. Ethics and dissemination The proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences. PROSPERO registration number CRD42019119361.
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carotid endarterectomy with primary closure versus Patch Angioplasty in patients with symptomatic and significant stenosis protocol for a systematic review with meta analyses and trial sequential analysis of randomised clinical trials
BMJ Open, 2019Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Christian Gluud, Frans L Moll, Frederik Keus, Amine Karimi, G G KoningAbstract:Introduction Use of Patch Angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with Patch Angioplasty in patients with a symptomatic and significant carotid stenosis. Methods and analysis The review shall be conducted according to this published protocol following the recommendations of the ‘Cochrane’ and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with Patch Angioplasty (regardless of used Patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses. Ethics and dissemination The proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences. PROSPERO registration number CRD42014013416.
Kittipan Rerkasem - One of the best experts on this subject based on the ideXlab platform.
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systematic review of randomized controlled trials of Patch Angioplasty versus primary closure and different types of Patch materials during carotid endarterectomy
Asian Journal of Surgery, 2011Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:Objective Patch Angioplasty during carotid endarterectomy (CEA) can reduce the risk of perioperative stroke or late carotid artery recurrent stenosis and subsequent ischaemic stroke. We aimed to update our previous systematic review of randomized controlled trials (RCTs) of routine or selective carotid Patch Angioplasty compared with CEA with primary closure, and of different materials used for carotid Patch Angioplasty. Methods We identified new RCTs published during 2002-2010 by searching Medline, Embase and the Cochrane Stroke Group Trials Register. We also hand-searched six relevant journals. Pooled estimates of treatment effects combined with our previous review (1966-2001) were calculated on the basis of a weighted estimate of the odds ratio (OR) with the Peto method. Results Twenty-three eligible RCTs were identified in both periods. Ten RCTs involving 2,157 operations compared primary closure with routine Patch closure. Patch closure significantly reduced the combined risk of perioperative stroke and later stroke during long-term follow-up [OR = 0.49, 95% confidence interval (CI) = 0.27-0.90, p = 0.001; 7 RCTs]. Patching also reduced the risks of perioperative arterial occlusion (OR = 0.18, 95% CI=0.08-0.41, p p Conclusion Meta-analysis of relatively small RCTs suggests that carotid Patch Angioplasty reduces the combined perioperative and long-term risk of stroke and the risk of restenosis. More data are needed.
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Patches of different types for carotid Patch Angioplasty
Cochrane Database of Systematic Reviews, 2010Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:Background 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. Objectives To assess the safety and efficacy of different types of Patch materials used in carotid Patch Angioplasty. The primary hypothesis was that a synthetic material was associated with lower risk of Patch rupture versus venous Patches, but that venous Patches were associated with lower risk of perioperative stroke and early or late infection, or both. Search methods We searched the Cochrane Stroke Group trials register (last searched 25 May 2020); the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4), in the Cochrane Library; MEDLINE (1966 to 25 May 2020); Embase (1980 to 25 May 2020); the Index to Scientific and Technical Proceedings (1980 to 2019); the Web of Science Core Collection; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal. We handsearched relevant journals and conference proceedings, checked reference lists, and contacted experts in the field. Selection criteria Randomised and quasi-randomised trials (RCTs) comparing one type of carotid Patch with another for CEA. Data collection and analysis 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. Main results 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. Authors' conclusions The number of outcome events is too small to allow conclusions, and more trial data are required to establish whether any differences do exist. Nevertheless, there is little to no difference in effect on perioperative and long-term ipsilateral stroke between vein and any synthetic Patch material. Some evidence indicates that other synthetic Patches (e.g. PTFE) may be superior to Dacron grafts in terms of perioperative stroke and TIA rates, and both early and late arterial re-stenosis and occlusion. Pseudoaneurysm formation may be more common after use of a vein Patch than after use of a synthetic Patch. Bovine pericardial Patch, which is an acellular xenograft material, may reduce the risk of perioperative fatal stroke, death, and infection compared to other synthetic Patches. Further large RCTs are required before definitive conclusions can be reached.
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Patch Angioplasty versus primary closure for carotid endarterectomy
Cochrane Database of Systematic Reviews, 2009Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:BACKGROUND Carotid Patch Angioplasty (with either a venous or a synthetic Patch) may reduce the risk of carotid artery restenosis and subsequent ischaemic stroke. OBJECTIVES The objective of this review was to assess the safety and efficacy of routine or selective carotid Patch Angioplasty compared to carotid endarterectomy with primary closure. SEARCH STRATEGY We searched the Cochrane Stroke Group Trials Register (last searched November 2002). In addition, we searched the Cochrane Controlled Trials Register (The Cochrane Library, Issue 4, 2001), MEDLINE (1966 to December 2001), EMBASE (1980 to December 2001) and Index to Scientific and Technical Proceedings (1980 to 2001). We also handsearched eight journals and five conference proceedings. Reference lists were checked and we contacted experts in the field to identify further published and unpublished studies. SELECTION CRITERIA Randomised and quasi-randomised trials comparing carotid Patch Angioplasty with primary closure in any patients undergoing carotid endarterectomy. DATA COLLECTION AND ANALYSIS Two reviewers independently assessed eligibility, trial quality and extracted the data. MAIN RESULTS The previous review included six trials involving 794 patients undergoing 882 operations. Since the last review only one study of adequate quality to be included has been reported. This added 399 operations randomised to either primary closure, vein Patch or synthetic Patch groups resulting in 1127 patients undergoing 1307 operations being available for analysis. The quality of trials was generally poor. Follow-up varied from hospital discharge to five years. Carotid Patch Angioplasty was associated with a reduction in the risk of stroke of any type (OR = 0.33, p = 0.004), ipsilateral stroke (OR = 0.31, p = 0.0008), and stroke or death, during the perioperative period (OR = 0.39, p = 0.007) and long term follow-up (OR = 0.59, p = 0.004). It was also associated with a reduced risk of perioperative arterial occlusion (odds ratio 0.15, 95% confidence interval 0.06 to 0.37 p = 0.00004), and decreased restenosis during long-term follow-up in five trials, (odds ratio 0.20, 95% confidence interval 0.13 to 0.29 p < 0.00001). These results are more certain than those of the previous review since the number of operations and events have increased. However, the sample sizes are still relatively small, data were not available from all trials, and there was significant loss to follow-up. Very few arterial complications, including haemorrhage, infection, cranial nerve palsies and pseudo-aneurysm formation were recorded with either Patch or primary closure. No significant correlation was found between use of Patch Angioplasty and the risk of either perioperative or long-term all-cause death rates REVIEWERS' CONCLUSIONS Limited evidence suggests that carotid Patch Angioplasty may reduce the risk of perioperative arterial occlusion and restenosis. It would appear to reduce the risk of combined death or stroke and there is a non significant trend towards a reduction in all-cause mortality.
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systematic review of randomized controlled trials of Patch Angioplasty versus primary closure during carotid endarterectomy
Stroke, 2005Co-Authors: Kittipan Rerkasem, Peter M RothwellAbstract:Section Editors: Geoffrey A. Donnan MD, FRACP Stephen M. Davis MD, FRACP Carotid endarterectomy has been shown to reduce the risk of stroke in selected patients with internal carotid artery stenosis. Carotid Patch Angioplasty performed during surgery may reduce the risk of restenosis, and consequently reduce the long-term risk of recurrent stroke. However, Patching itself may be associated with complications. We tested the hypothesis that carotid Patch Angioplasty resulted in a lower rate of significant arterial re-stenosis and therefore fewer recurrent strokes and stroke-related deaths without an increase in perioperative complications. Two reviewers independently searched MEDLINE (1996 to April 2003), EMBASE (1980 to 2002), and Index to Scientific and Technical Proceedings (1980 to 1994). We also searched the Stroke Group trials register (April 2003), hand-searched 13 relevant journals up to 2002, …
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systematic review of randomized controlled trials of Patch Angioplasty versus primary closure and different types of Patch materials during carotid endarterectomy
Journal of Vascular Surgery, 2004Co-Authors: R Bond, Kittipan Rerkasem, A R Naylor, Ali F Aburahma, Peter M RothwellAbstract:Background Patch Angioplasty during carotid endarterectomy (CEA) may reduce the risk for perioperative or late carotid artery recurrent stenosis and subsequent ischemic stroke. We performed a systematic review of randomized controlled trials to assess the effect of routine or selective carotid Patch Angioplasty compared with CEA with primary closure, and the effect of different materials used for carotid Patch Angioplasty. Methods Randomized trials were included if they compared carotid Patch Angioplasty with primary closure in any patients undergoing CEA or use of one type of carotid Patch with another. Results Thirteen eligible randomized trials were identified. Seven trials involving 1281 operations compared primary closure with routine Patch closure, and 8 trials with 1480 operations compared different Patch materials (2 studies compared both). Patch Angioplasty was associated with a reduction in risk for stroke of any type (P = .004), ipsilateral stroke (P = .001), and stroke or death during both the perioperative period (P = .007) and long-term follow-up (P = .004). Patching was also associated with reduced risk for perioperative arterial occlusion (P = .0001) and decreased recurrent stenosis during long-term follow-up (P Conclusions Carotid Patch Angioplasty decreases the risk for perioperative death or stroke, and long-term risk for ipsilateral ischemic stroke. More data are required to establish differences between various Patch materials.
Christian Gluud - One of the best experts on this subject based on the ideXlab platform.
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carotid endarterectomy with Patch Angioplasty versus primary closure in patients with symptomatic and significant stenosis a systematic review with meta analyses and trial sequential analysis of randomized clinical trials
Systematic Reviews, 2021Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Christian Gluud, Frans L Moll, Frederik Keus, G G KoningAbstract:Patch Angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques. Searches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with Patch Angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events. We included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with Patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with Patch Angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for Patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for Patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation. This systematic review showed no conclusive evidence of a difference between carotid endarterectomy with Patch Angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials Patch Angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200–7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned. PROSPERO CRD42014013416 . Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .
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carotid endarterectomy with primary closure versus Patch Angioplasty in patients with symptomatic and significant stenosis protocol for a systematic review with meta analyses and trial sequential analysis of randomised clinical trials
BMJ Open, 2019Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Christian Gluud, Frans L Moll, Frederik Keus, Amine Karimi, G G KoningAbstract:Introduction Use of Patch Angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with Patch Angioplasty in patients with a symptomatic and significant carotid stenosis. Methods and analysis The review shall be conducted according to this published protocol following the recommendations of the ‘Cochrane’ and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with Patch Angioplasty (regardless of used Patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses. Ethics and dissemination The proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences. PROSPERO registration number CRD42014013416.
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carotid endarterectomy with Patch Angioplasty versus primary closure in patients with symptomatic and significant stenosis a systematic review with meta analyses and trial sequential analysis of randomized clinical trials
Systematic Reviews, 2021Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Christian Gluud, Frans L Moll, Frederik Keus, G G KoningAbstract:Patch Angioplasty in conventional carotid endarterectomy is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke compared with primary closure. A systematic review of randomized clinical trials is needed to compare outcomes (benefits and harms) of both techniques. Searches (CENTRAL, PubMed/MEDLINE, EMBASE, and other databases) were last updated 3rd of January 2021. We included randomized clinical trials comparing carotid endarterectomy with Patch Angioplasty versus primary closure of the arterial wall in patients with a symptomatic and significant (> 50%) carotid stenosis. Primary outcomes are defined as all-cause mortality and serious adverse events. We included 12 randomized clinical trials including 2187 participants who underwent 2335 operations for carotid stenosis comparing carotid endarterectomy with Patch closure (1280 operations) versus carotid endarterectomy with primary closure (1055 operations). Meta-analysis comparing carotid endarterectomy with Patch Angioplasty versus carotid endarterectomy with primary closure may potentially decrease the number of patients with all-cause mortality (RR 0.53; 95% CI 0.26 to 1.08; p = 0.08, best-case scenario for Patch), serious adverse events (RR 0.73; 95% CI 0.56 to 0.96; p = 0.02, best-case scenario for Patch), and the number of restenosis (RR 0.41; 95% CI 0.23 to 0.71; p < 0.01). Trial sequential analysis demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All the patient-relevant outcomes were at low certainty of evidence according to The Grading of Recommendations Assessment, Development, and Evaluation. This systematic review showed no conclusive evidence of a difference between carotid endarterectomy with Patch Angioplasty versus primary closure of the arterial wall on all-cause mortality, < 30 days mortality, < 30 days stroke, or any other serious adverse events. These conclusions are based on data from 15 to 35 years ago, obtained in trials with very low certainty according to GRADE, and should be interpreted cautiously. Therefore, we suggest conducting new randomized clinical trials Patch Angioplasty versus primary closure in carotid endarterectomy in symptomatic patients with an internal carotid artery stenosis of 50% or more. Such trials ought to be designed according to the Standard Protocol Items: Recommendations for Interventional Trials statement (Chan et al., Ann Intern Med 1:200–7, 2013) and reported according to the Consolidated Standards of Reporting Trials statement (Schulz et al., 7, 2010). Until conclusive evidence is obtained, the standard of care according to guidelines should not be abandoned. PROSPERO CRD42014013416 . Review protocol publication 2019 DOI: https://doi.org/10.1136/bmjopen-2018-026419 .
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eversion technique versus conventional endarterectomy with Patch Angioplasty in carotid surgery protocol for a systematic review with meta analyses and trial sequential analysis of randomised clinical trials
BMJ Open, 2020Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Frans L Moll, Frederik Keus, P W H E Vriens, Ronald L A W Bleys, G G KoningAbstract:Introduction Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of Patch Angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with Patch Angioplasty in patients with symptomatic carotid stenosis. Methods and outcomes The review will be conducted according to this protocol following the recommendations of the ‘Cochrane Handbook for Systematic Reviews’ and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with Patch Angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses. Ethics and dissemination The proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences. PROSPERO registration number CRD42019119361.
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carotid endarterectomy with primary closure versus Patch Angioplasty in patients with symptomatic and significant stenosis protocol for a systematic review with meta analyses and trial sequential analysis of randomised clinical trials
BMJ Open, 2019Co-Authors: Martijn S Marsman, Jorn Wetterslev, Abdelkarime Kh Jahrome, Christian Gluud, Frans L Moll, Frederik Keus, Amine Karimi, G G KoningAbstract:Introduction Use of Patch Angioplasty in carotid endarterectomy (CEA) is suggested to reduce the risk of restenosis and recurrent ipsilateral stroke. The objective is to conduct a systematic review with meta-analysis and trial sequential analysis as well as Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments comparing the benefits and harms of CEA with primary closure of the arterial wall versus CEA with Patch Angioplasty in patients with a symptomatic and significant carotid stenosis. Methods and analysis The review shall be conducted according to this published protocol following the recommendations of the ‘Cochrane’ and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Randomised clinical trials comparing CEA with primary closure of the arterial wall versus CEA with Patch Angioplasty (regardless of used Patch materials) in human adults with a symptomatic and significant carotid stenosis will be included. Primary outcomes are all-cause mortality at maximal follow-up, health-related quality of life and serious adverse events. Secondary outcomes are symptomatic or asymptomatic arterial occlusion or restenosis, and non-serious adverse events. We will primarily base our conclusions on meta-analyses of trials with overall low risk of bias. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the precision achieved in all trials as the result of our meta-analyses. Ethics and dissemination The proposed systematic review will collect and analyse secondary data from published studies therefor ethical approval is not required. The results of the systematic review will be disseminated by publication in a peer-review journal and submitted for presentation at relevant conferences. PROSPERO registration number CRD42014013416.