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颈动脉内膜切除术时斑块切除术与直接缝合的比较。

Patch angioplasty versus primary closure for carotid endarterectomy.

机构信息

Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), Pathum Thani, Thailand.

Environmental - Occupational Health Sciences and Non-Communicable Diseases Research Group, Research Institute of Health Sciences, Chiang Mai University, Chiang Mai, Thailand.

出版信息

Cochrane Database Syst Rev. 2022 Aug 3;8(8):CD000160. doi: 10.1002/14651858.CD000160.pub4.

Abstract

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 follow-up (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.

摘要

背景

颈动脉内膜切除术(CEA)中使用颈动脉补片血管成形术可能会降低急性闭塞或颈动脉长期再狭窄以及随后缺血性中风的风险。这是 Cochrane 综述的更新,最初发表于 1995 年,于 2008 年更新。

目的

评估在 CEA 中使用静脉补片或合成补片进行常规或选择性颈动脉补片血管成形术与直接缝合相比的安全性和有效性。我们希望验证主要假设,即颈动脉补片血管成形术可降低严重动脉再狭窄的发生率,从而减少复发性中风和中风相关死亡,而不会显著增加围手术期并发症。

检索方法

我们于 2021 年 9 月检索了 Cochrane 卒中组试验注册库、CENTRAL、MEDLINE、Embase、另外两个数据库和两个试验注册库。

选择标准

随机对照试验和准随机试验,比较颈动脉补片血管成形术与 CEA 中直接缝合的效果。

数据收集和分析

两名综述作者独立评估纳入标准和偏倚风险;提取数据;并使用 GRADE 方法确定证据的确定性。主要结果包括中风、死亡、与手术相关的严重并发症以及围手术期(手术 30 天内)或长期随访期间的动脉再狭窄或闭塞。

主要结果

我们纳入了 11 项试验,涉及 2100 名接受 2304 次 CEA 手术的患者。试验的质量普遍较差。随访时间从出院到五年不等。与直接缝合相比,颈动脉补片血管成形术可能对降低围手术期任何中风的风险影响不大(比值比(OR)0.57,95%置信区间(CI)0.31 至 1.03;P = 0.063;8 项研究,1769 名参与者;极低确定性证据),但可能降低长期随访期间任何中风的风险(OR 0.49,95%CI 0.27 至 0.90;P = 0.022;7 项研究,1332 名参与者;极低确定性证据)。在纳入的研究中,颈动脉补片血管成形术降低了围手术期同侧中风的风险(OR 0.31,95%CI 0.15 至 0.63;P = 0.001;7 项研究,1201 名参与者;极低确定性证据),以及长期随访期间的中风风险(OR 0.32,95%CI 0.16 至 0.63;P = 0.001;6 项研究,1141 名参与者;极低确定性证据)。该干预措施与降低长期随访期间任何中风或死亡的风险相关(OR 0.59,95%CI 0.42 至 0.84;P = 0.003;6 项研究,1019 名参与者;极低确定性证据)。此外,纳入的研究表明,颈动脉补片血管成形术可能降低围手术期动脉闭塞的风险(OR 0.18,95%CI 0.08 至 0.41;P < 0.0001;7 项研究,1435 名参与者;低确定性证据),并可能降低长期随访期间的再狭窄风险(OR 0.24,95%CI 0.17 至 0.34;P < 0.00001;8 项研究,1719 名参与者;低确定性证据)。这些研究记录了很少的动脉并发症,包括出血、感染、颅神经麻痹和假性动脉瘤形成,使用补片或直接缝合的情况均如此。我们没有发现补片血管成形术的使用与围手术期或长期中风相关死亡或全因死亡率的风险之间存在相关性。

作者结论

与直接缝合相比,颈动脉补片血管成形术可能降低围手术期动脉闭塞和手术动脉长期再狭窄的风险。与直接缝合相比,它似乎降低了围手术期和长期同侧中风的风险,并降低了长期随访期间任何中风的风险。然而,由于纳入试验的质量有限,证据尚不确定。

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