Trial reportAnnals of surgery2003
Prospective randomized trial of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated dacron (Hemashield) patching: late follow-up.
Trial report in Annals of surgery, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Patches of different types for carotid patch angioplasty.The Cochrane database of systematic reviews · 2021Pooled it
- Systematic review of randomized controlled trials of different types of patch materials during carotid endarterectomy.PloS one · 2013Pooled it
- Patches of different types for carotid patch angioplasty.The Cochrane database of systematic reviews · 2010Pooled it
- Prospective randomized trial of ACUSEAL versus Vascu-Guard patching in carotid endarterectomy.Annals of vascular surgery · 2014Trial
- Cardiovascular patches applied in congenital cardiac surgery: Current materials and prospects.Bioengineering & translational medicine · 2025Review
- An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.Journal of vascular surgery · 2024Review
- Outcomes of Arteriotomy Closure Technique for Carotid Endarterectomy: Bovine Pericardial Patch Closure versus Primary Closure.Brazilian journal of cardiovascular surgery · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the late clinical outcome and incidence of recurrent stenosis after carotid endarterectomy (CEA) with polytetrafluoroethylene (PTFE) versus Hemashield patching. SUMMARY BACKGROUND DATA: Several randomized trials have confirmed the advantages of patching over primary closure when performing CEA.
methodsTwo hundred CEAs (180 patients) were randomized into 100 with PTFE patching and 100 with Hemashield. All patients underwent postoperative color duplex ultrasounds at 1, 6, and 12 months, and every year thereafter. The mean follow-up was 26 months. Kaplan-Meier analysis was used to estimate the risk of re-stenosis, stroke, and stroke-free survival. A multivariate analysis of various risk factors was also done.
resultsDemographic and clinical characteristics were similar in both groups. The incidence of all ipsilateral strokes (early and late) was 8% (7% perioperative) for Hemashield versus 0% for PTFE patching. Both groups had similar mortality rates. The cumulative stroke-free rates at 6, 12, 24, and 36 months were 93%, 93%, 93%, and 89% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE patching. The cumulative stroke-free survival rates at 6, 12, 24, and 36 months were 90%, 89%, 87%, and 79% for Hemashield versus 98%, 98%, 92%, and 92% for PTFE patching. Kaplan-Meier analysis also showed that freedom from 50% or greater re-stenosis at 6, 12, 24, and 36 months was 89%, 81%, 73%, and 66% for Hemashield versus 100%, 100%, 100%, and 92% for PTFE. Similarly, the freedom from 70% or greater re-stenosis at 6, 12, 24, and 36 months was 93%, 91%, 86%, and 78% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE. Univariate and multivariate analyses of demographic and preoperative risk factors showed that only Hemashield was significantly associated with a higher incidence of 70% or greater recurrent stenosis.
conclusionsPTFE patching was superior to Hemashield in lowering the incidence of postoperative ipsilateral strokes and late recurrent stenosis.
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