Systematic Review of Randomized Controlled Trials of Patch Angioplasty Versus Primary Closure During Carotid Endarterectomy
Graeme J. Hankey MD, FRACP, FRCP Section Editor
Carotid endarterectomy has been shown to reduce the risk of stroke in selected patients with internal carotid artery stenosis.1,2 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. We therefore performed a systematic review of trials of carotid patch angioplasty versus primary closure.
Two reviewers independently searched MEDLINE (1996 to November 2008), EMBASE (1980 to November 2008), and Index to Scientific and Technical Proceedings (1980 to 2008).3 We also searched the Stroke Group trials register (May 2009), hand-searched 6 relevant journals up to 2008, and searched the reference lists of articles identified. Randomized and quasirandomized trials comparing carotid patch angioplasty with primary closure in any patients undergoing carotid endarterectomy were included. Any type of patch material was eligible. Thirty-day and long-term risks of stroke, death, ipsilateral stroke, restenosis (>50%), and wound complications were independently extracted by 2 reviewers (K.R., P.M.R). Proportional risk reductions were calculated using the Peto method. Heterogeneity between trial results was tested using the standard I2 test.
Ten trials involving 1967 patients undergoing 2157 operations were included.3 Follow-up varied from hospital discharge to 5 years. Three trials used only vein patches, 3 trials used only synthetic patches, and 4 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 restenosis was assessed blind in all but 2 trials.
The overall perioperative risks of any stroke, ipsilateral stroke, and death were 2.5% (45 of 1769 patients), 2.7% (33 of 1201 patients), and 0.6% (11 of 1869 patients), respectively. Overall estimates of treatment effect from meta-analysis of the 10 trials are shown in the Table. Carotid patch angioplasty was associated with a reduction in the risk of any perioperative ipsilateral stroke (P=0.001), reduced perioperative arterial occlusion (P<0.0001), and decreased restenosis during long-term follow-up in 8 trials (P<0.00001). Risk of stroke and death was also reduced on long-term follow-up (P=0.004).
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.
Implications for Practice
This review shows a significant reduction in perioperative and long-term risks of ipsilateral stroke and of perioperative carotid occlusion and later restenosis 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.
Implication for Research
The results of this review support a policy of routine patching, but most included trials were small and some had methodological shortcomings. More trials could therefore be justified.
- Received September 29, 2009.
- Accepted October 8, 2009.
Rothwell PM, Gutnikov SA, Eliasziw M, Fox AJ, Taylor W, Mayberg MR, Warlow CP, Barnett HJM, for the Carotid Endarterectomy Trialists Collaboration. Pooled analysis of individual patient data from randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet. 2003; 361: 107–116.