Patch angioplasty versus primary closure for carotid endarterectomy

Background Carotid patch angioplasty may reduce the risk of acute occlusion or long-term restenosis of the carotid artery and subsequent ischaemic stroke in people undergoing carotid endarterectomy (CEA). This is an update of a Cochrane Review originally published in 1995 and updated in 2008. Objectives To assess the safety and efficacy of routine or selective carotid patch angioplasty with either a venous patch or a synthetic patch compared with primary closure in people undergoing CEA. We wished to test the primary hypothesis that carotid patch angioplasty results in a lower rate of severe arterial restenosis and therefore fewer recurrent strokes and stroke-related deaths, without a considerable increase in perioperative complications. Search methods We searched the Cochrane Stroke Group trials register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registries in September 2021. Selection criteria Randomised controlled trials and quasi-randomised trials comparing carotid patch angioplasty with primary closure in people undergoing CEA. Data collection and analysis Two review authors independently assessed eligibility and risk of bias; extracted data; and determined the certainty of evidence using the GRADE approach. Outcomes of interest included stroke, death, significant complications related to surgery, and artery restenosis or occlusion during the perioperative period (within 30 days of the operation) or during long-term follow-up. Main results We included 11 trials involving 2100 participants undergoing 2304 CEA operations. The quality of trials was generally poor. Follow-up varied from hospital discharge to five years. Compared with primary closure, carotid patch angioplasty may make little or no difference to reduction in risk of any stroke during the perioperative period (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.31 to 1.03; P = 0.063; 8 studies, 1769 participants; very low-certainty evidence), but may lower the risk of any stroke during long-term follow-up (OR 0.49, 95% CI 0.27 to 0.90; P = 0.022; 7 studies, 1332 participants; very low-certainty evidence). In the included studies, carotid patch angioplasty resulted in a lower risk of ipsilateral stroke during the perioperative period (OR 0.31, 95% CI 0.15 to 0.63; P = 0.001; 7 studies, 1201 participants; very low-certainty evidence), and during long-term follow-up (OR 0.32, 95% CI 0.16 to 0.63; P = 0.001; 6 studies, 1141 participants; very low-certainty evidence). The intervention was associated with a reduction in the risk of any stroke or death during long-term followup (OR 0.59, 95% CI 0.42 to 0.84; P = 0.003; 6 studies, 1019 participants; very low-certainty evidence). In addition, the included studies suggest that carotid patch angioplasty may reduce the risk of perioperative arterial occlusion (OR 0.18, 95% CI 0.08 to 0.41; P < 0.0001; 7 studies, 1435 participants; low-certainty evidence), and may reduce the risk of restenosis during long-term follow-up (OR 0.24, 95% CI 0.17 to 0.34; P < 0.00001; 8 studies, 1719 participants; low-certainty evidence). The studies recorded very few arterial complications, including haemorrhage, infection, cranial nerve palsies and pseudo-aneurysm formation, with either patch or primary closure. We found no correlation between the use of patch angioplasty and the risk of either perioperative or long-term stroke-related death or all-cause death rates. Authors' conclusions Compared with primary closure, carotid patch angioplasty may reduce the risk of perioperative arterial occlusion and long-term restenosis of the operated artery. It would appear to reduce the risk of ipsilateral stroke during the perioperative and long-term period and reduce the risk of any stroke in the long-term when compared with primary closure. However, the evidence is uncertain due to the limited quality of included trials.