Stroke. 2005;36:1350-1351
Published online before print April 28, 2005,
doi: 10.1161/01.STR.0000165903.73027.f1
(Stroke. 2005;36:1350.)
© 2005 American Heart Association, Inc.
A Systematic Review of Randomized Controlled Trials of Different Types of Patch Materials During Carotid Endarterectomy
R. Bond, MBBS, Dphil FRCS;
K. Rerkasem, MD, PhD;
A.R. Naylor, MD, FRCS
P.M. Rothwell, MD, PhD, FRCP
From the Stroke Prevention Research Unit (R.B., K.R., P.M.R.), University Department of Clinical Neurology, Radcliffe Infirmary, Oxford, UK; the Vascular Group (K.R.), Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; and the Department of Vascular and Endovascular Surgery (A.R.N.), Leicester Royal Infirmary, Leicester, UK.
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 Editor: Graeme J. Hankey MD, FRCP
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Introduction
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Patch angioplasty performed during carotid endarterectomy may
reduce the risk of re-stenosis and consequently reduce the long-term
risk of recurrent stroke. However, there is uncertainty as to
the optimal patch material.
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Objectives
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We sought to determine whether any particular patch material
was associated with a lower risk of perioperative and/or long-term
complications than any other.
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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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We sought to identify all randomized and quasi randomized trials
in which one type of carotid patch was compared with another.
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Data Collection and Analysis
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Thirty-day and long-term risks of stroke, death, restenosis
(>50%), and wound complications were independently extracted
by 2 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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Eight trials (1480 operations) were included in the review.
Four compared vein to polytetrafluoroethylene (PTFE) closure,
3 compared vein to Dacron, and 1 compared PTFE with Dacron.
There were several flaws in the trials. Three failed to use
adequate randomization techniques. Three failed to perform blind
follow-up and 1 study used heparin reversal at the end of surgery
in 30% of their synthetic closures but none of their vein closure
patients.
Figure 1 summarizes the results. The absolute risks of perioperative stroke (1.7%, 19/1122), death (1.1%, 12/1122) and combined stroke and death (2.4%, 27/1122) were all very low, and consequently it was not possible to determine reliably whether there was any difference between the vein and Dacron patches for perioperative stroke, death, and arterial complications. During follow-up of >1 year, no difference was shown between the 2 types of patch for the risk of stroke, death, or arterial restenosis. However, there were significantly fewer pseudoaneurysms associated with synthetic patches than vein (odds ratio, 0.07; 95% confidence interval, 0.02 to 0.49). However, the clinical significance of this finding is uncertain because of small numbers and poor definitions of pseudoaneurysm. One study compared Hemoshield Dacron and PTFE patches. PTFE was associated with a lower risk of combined stroke and transient ischemic attack (P=0.03) and restenosis at 30 days (P=0.01), and perioperative stroke (P=0.06).
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Summary estimates of treatment effect from all meta-analyzed outcomes from 7 trials (1280 operations) comparing vein with synthetic patch angioplasty that were included in the review. Data were not available for all outcomes from all trials, and there was significant loss to follow-up.
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Implications for Practice
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This review found no differences in the risks of perioperative
or long-term stroke, death, or local complications experienced
by patients receiving synthetic or venous patches. There is
still little evidence to guide surgeons on which patch material
to use. Synthetic patches do spare the morbidity associated
with vein harvesting and leave vein for future bypass grafting.
However, PTFE may increase the operation time because of increased
bleeding. There is limited evidence that PTFE has a lower 30-day
stroke, transient ischemic attack, and restenosis rate than
Hemoshield Dacron.
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Implications for Research
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The risk of major arterial complications such as rupture or
infection was very low in both treatment groups in all trials.
Any trials designed to detect a reduction in risk would, therefore,
need to be very large, and differences in risks between patch
types are likely to be 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, Naylor R, Rothwell PM. Patches of different types for carotid patch angioplasty. Cochrane Database Syst Rev. 2004, Issue 2.
Received October 19, 2004;
accepted October 22, 2004.
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Introduction
Objectives