The Edinburgh Extended Glasgow Outcome Scale (EEGOS): rationale and pilot studies

OBJECTIVES: To determine whether patch angioplasty is more effective than primary closure in carotid endarterectomy, and whether one type of patch is better than another. DESIGN: Systematic review of the randomised trials. MATERIALS: Trials were identified from the Cochrane Stroke Review Group database plus additional handsearching, electronic searching, and personal contact. METHODS: Two authors independently selected studies for inclusion and extracted details of trial quality and data on the following outcomes: any stroke; stroke ipsilateral to the operated artery; death; occlusion or restenosis, and other significant arterial complications. Meta-analysis of odds ratios (OR) was performed using the Peto method. RESULTS: Six trials (882 operations) compared routine patching with primary closure. Routine patching was associated with significant reductions in the risks of ipsilateral stroke during the perioperative period (OR 0.34, 95% CI 0.15-0.76) and during long-term follow-up (OR 0.38, 95% CI 0.16-0.88). Significant reductions in the odds of any stroke, stroke or death, acute arterial occlusion and long-term restenosis were also found. However, these results were based on very small numbers of outcome events and may be biased by losses to follow-up and publication bias. Three trials (326 operations) compared the use of polytetrafluoroethylene patches with venous patches. There were too few events (strokes, deaths, arterial complications) to determine whether there were significant differences between the patch materials. Fewer pseudoaneurysms occurred in those who received synthetic patches but the clinical consequence of this was unclear. CONCLUSIONS: Routine carotid patch angioplasty was associated with promising reductions in the risks of ipsilateral stroke and death, but the results should be interpreted cautiously because of the small number of outcome events, significant losses to follow-up, and poor trial methodology. Ideally, a large definitive trial should be performed. There is insufficient evidence to support the preferential use of one particular type of patch versus another.