Patch angioplasty versus primary closure for carotid endarterectomy

 

Abstract

Background

Carotid patch angioplasty (with either a venous or a synthetic patch) may reduce the risk of carotid artery restenosis and subsequent ischaemic stroke. This is an update of a Cochrane Review originally published in 1995 and previously updated in 2004.

Objectives

To assess the safety and efficacy of routine or selective carotid patch angioplasty compared to carotid endarterectomy with primary closure.

Search methods

We searched the Cochrane Stroke Group Trials Register (last searched 5 May 2009), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2009), MEDLINE (1966 to November 2008), EMBASE (1980 to November 2008) and Index to Scientific and Technical Proceedings (1980 to November 2008). We handsearched journals and conference proceedings, checked reference lists, and contacted experts in the field.

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 review authors independently assessed eligibility, trial quality and extracted data.

Main results

We included 10 trials involving 1967 patients undergoing 2157 operations. 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 ipsilateral stroke during the perioperative period (odds ratio (OR) 0.31, 95% confidence interval (CI) 0.15 to 0.63, P = 0.001) and long-term follow up (OR 0.32, 95%CI 0.16 to 0.63, P = 0.001). It was also associated with a reduced risk of perioperative arterial occlusion (OR 0.18, 95% CI 0.08 to 0.41, P < 0.0001), and decreased restenosis during long-term follow up in eight trials (OR 0.24, 95% CI 0.17 to 0.34, 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.

Authors' 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 ipsilateral stroke and there is a non significant trend towards a reduction in perioperative any stroke rate and all-cause case fatality.

 

Plain language summary

Patch angioplasty versus primary closure for carotid endarterectomy

Evidence from this review of 10 trials involving 1967 patients undergoing 2157 operations now suggests a benefit from using routine patch angioplasty during carotid endarterectomy. About 20% of strokes result from narrowing of the carotid artery (the main artery supplying blood to the brain). Carotid endarterectomy is an operation that involves opening the carotid artery to remove this narrowing and, therefore, reduce the risk of stroke. However, there is a 2% to 10% risk of the operation itself causing a stroke. Some surgeons advocate the incorporation of a patch made out of either synthetic material or the patient's own vein, into the arterial closure. This may help to reduce the risk of the artery being narrowed during suture placement and may, therefore, reduce the risk of recurrent blockage and consequent stroke or death or both. However, use of a patch may increase surgical difficulty and operation length. Furthermore, thin-walled vein patches may rupture with potentially fatal consequences and synthetic materials are vulnerable to infection.

 

摘要

背景

比較血管補片與直接縫合在頸動脈內膜剝除術中之應用

頸動脈血管補片(使用靜脈補片或合成補片)可能降低頸動脈再狹窄以及後續梗塞型中風之危險性。這是從原先發表在1995年並於2004年更新過的Cochrane Review所做的更新版。

目標

評估例行性或選擇性的頸動脈血管補片使用與直接縫合在頸動脈內膜剝除術之安全性及效益。

搜尋策略

我們搜尋Cochrane Stroke Group Trials Register(搜尋至 5 May 2009)、Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library, Issue 1, 2009)、MEDLINE(1966 to November 2008)、EMBASE(1980 to November 2008)以及Index to Scientific and Technical Proceedings(1980 to November 2008)。我們尋找了期刊與會議記錄、核對參考文獻並且聯絡該領域的專家。

選擇標準

比較任一病人在進行頸動脈內膜剝除術中使用頸動脈補片與直接縫合兩者之隨機(randomised)及準隨機(quasirandomised)分派試驗。

資料收集與分析

兩位檢閱者獨立評估納入資格、試驗品質以及摘錄資料。

主要結論

我們納入10項試驗，共計1967位病人進行了2157次手術。試驗的品質普遍不良。術後追蹤從出院至5年不等。頸動脈血管補片可降低手術間期(odds ratio (OR) 0.31, 95% confidence interval (CI) 0.15 to 0.63, P = 0.001)及長期追蹤時(OR 0.32, 95% CI 0.16 to 0.63, P = 0.001)的同側性中風的風險。它並可降低手術期間動脈阻塞風險(OR 0.18, 95% CI 0.08 to 0.41, P < 0.0001)，以及在8個試驗中降低長期追蹤之再狹窄率(OR 0.24, 95% CI 0.17 to 0.34, P < 0.00001)。這些結果比先前的回顧更加確定，因為手術及事件次數增加了。但是樣本數仍然相對較小；無法從所有試驗都得到資料，而且失去追蹤的情形也很顯著。不管在補片或直接縫合兩者，動脈的併發症，包括出血、感染、顱神經麻痺與假性動脈瘤形成，都鮮少被紀錄。血管補片的使用與手術間期或長期追蹤之全部死亡率之間並沒有發現明顯的關聯。

作者結論

頸動脈血管補片可以降低手術期間動脈阻塞及再狹窄風險的證據並不足。它顯得能夠降低同側性中風的風險，並且對於手術間期的中風率及全部的死亡率有一非顯著性降低的趨勢。

翻譯人

本摘要由奇美醫院陳軾正翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

比較血管補片與直接縫合在頸動脈內膜剝除術中之應用。 這篇回顧10項試驗，共納入1967位病人進行了2157次手術的證據現在建議在頸動脈內膜剝除術中常規性使用血管補片是有益處的。約有20%的中風導因於頸動脈的狹窄(供應腦血流的主要動脈)。頸動脈內膜剝除術是一種牽涉到打開頸動脈以移除其狹窄的手術，因此減低了中風的風險。然而，手術本身即有2%至10%造成中風的風險。一些外科醫師提倡在動脈縫合之中併入一塊補片 – 使用合成材料或是以病人自己的靜脈做成。這或許可以幫助減少在縫合過程中動脈狹窄的風險，也因此降低了再阻塞以及後續中風與/或死亡的風險。然則，使用補片可能會增加手術的困難度與手術時間。再者，薄壁的靜脈補片可能會破裂而致潛在致死的結果，而合成材質則容易被感染。