Stroke. 2005;36:1814-1815
Published online before print July 21, 2005,
doi: 10.1161/01.STR.0000177499.67745.fc
(Stroke. 2005;36:1814.)
© 2005 American Heart Association, Inc.
Systematic Review of Randomized Controlled Trials of Patch Angioplasty Versus Primary Closure During Carotid Endarterectomy
R. Bond, MBBS, Dphil, FRCS;
K. Rerkasem, MD, PhD;
A.R. Naylor, MD, FRCS;
A.F. Abu Rahma, MD, FRCS, FACS
P.M. Rothwell, MD, PhD, FRCP
From the Stroke Prevention Research Unit (R.B., P.M.R.), University Department of Clinical Neurology, Radcliffe Infirmary, Oxford, UK; the Vascular Group, Department of Surgery (K.R.), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; the Department of Vascular and Endovascular Surgery (A.R.N.), Leicester Royal Infirmary, Leicester, UK; and the Department of Surgery (A.F.A.R.), Robert C. Byrd Health Sciences Center of West Virginia University, Charleston.
Correspondence to Prof P.M. Rothwell, Stroke Prevention Research Unit, Department of Clinical Neurology, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE, United Kingdom. E-mail peter.rothwell{at}clneuro.ox.ac.uk
Section Editors: Geoffrey A. Donnan MD, FRACP Stephen M. Davis MD, FRACP
Key Words: angioplasty • endarterectomy, carotid
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Introduction
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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.
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Objectives
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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.
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Search Strategy
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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, and searched the reference lists of articles identified.
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Selection Criteria
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Randomized and quasi-randomized trials comparing carotid patch
angioplasty with primary closure in any patients undergoing
carotid endarterectomy were included. Any type of patch material
was eligible.
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Data Collection and Analysis
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Thirty-day and long-term risks of stroke, death, ipsilateral
stroke, re-stenosis (>50%), and wound complications were
independently extracted by two reviewers (R.B., K.R.). Proportional
risk reductions were calculated using the Peto method. Heterogeneity
between trial results was tested using the standard
2 test.
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Main Results
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Seven trials involving 1193 patients undergoing 1281 operations
were analyzed. Follow-up varied from hospital discharge to 5
years. Three trials used only vein patches, 1 trial used only
PTFE patches, and 3 trials used both. The quality of trials
was variable. Allocation concealment was only adequate in 4
trials. Clinical assessment was definitely blinded in only 3
trials, but re-stenosis was assessed blind in all but 2 trials.
The overall perioperative risks of any stroke, ipsilateral stroke, and death were 2.8% (29/1019 patients), 2.7% (33/1201 patients), and 1.0% (10/1019 patients), respectively. Overall estimates of treatment effect from meta-analysis of the 7 trials are shown in the Figure. Carotid patch angioplasty was associated with a reduction in the risk of any perioperative stroke (odds ratio [OR]=0.33; 95% confidence interval [CI], 0.2 to 0.7; P=0.004), perioperative ipsilateral stroke (OR=0.32; 95% CI, 0.2 to 0.7; P=0.001), and stroke or death during the perioperative period (OR=0.40; 95% CI, 0.2 to 0.8; P=0.007). Patching was also associated with a reduced risk of perioperative arterial occlusion (OR=0.12; 95% CI, 0.06 to 0.4; P=0.00004), and decreased re-stenosis during long-term follow-up in 5 trials, (OR=0.22; 95% CI, 0.1 to 0.3; P<0.00001). Risk of stroke and death was also reduced on long-term follow-up (OR=0.54; 95% CI, 0.4 to 0.8; P=0.004).
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Summary estimates of treatment effect from all meta-analyzed outcomes from 7 trials comparing patch angioplasty versus primary closure: 1193 patients (1281 operations) were included in the review, but data were not available for all outcomes from all trials, and there was significant loss to follow-up.
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The sample sizes were relatively small, data were not available for all outcomes from all trials, and there was significant loss to follow-up. Furthermore, there were very few arterial complications, 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.
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Implications for Practice
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This review shows a significant reduction in perioperative and
long-term risks of stroke and of perioperative carotid occlusion
and later re-stenosis associated with the use of patching. A
policy of selective patching of only those arteries thought
to require a patch at the time of operation compared with no
patching has not been tested in randomized controlled trials.
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Implications for Research
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The results of this review appear to support a policy of routine
patching. However, more evidence is required, as numbers are
still small.
Note: The full text of this review is available in the Cochrane Library (for subscribers: http://www3.interscience.wiley.com/cgi-bin/mrwhome/106568753/HOME). The full article should be cited as: Bond R, Rerkasem K, AbuRahma AF, Naylor AR, Rothwell PM. Patch angioplasty versus primary closure for carotid endarterectomy. Cochrane Database Syst Rev 2004, Issue 2.
Received October 19, 2004;
accepted November 5, 2004.
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Introduction
Objectives