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Cited by 175Peripheral Artery Disease ManagementVascular Procedures and ComplicationsCentral Venous Catheters and Hemodialysis

Heparin-bonded Dacron or polytetrafluorethylene for femoropopliteal bypass: Five-year results of a prospective randomized multicenter clinical trial

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Devine, Carol, McCollum, Charles·2004·Journal of Vascular Surgery
DOI 10.1016/j.jvs.2004.08.033
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Abstract

Objective Dacron was largely abandoned for femoropopliteal bypass 30 years ago, because better patency rates were achieved with saphenous vein. Despite the range of potential prosthetics, polytetrafluoroethylne (PTFE) clearly predominates in current femoropopliteal practice. We compared heparin-bonded Dacron (HBD) with PTFE in a randomized multicenter clinical trial.Method Over 28 months, 209 patients (179 above-knee disease, 30 below-knee disease) were randomized to receive HBD (n = 106) or PTFE (n = 103) grafts. Aspirin, 300 mg/d, was started before surgery, and was continued if tolerated.Results At follow-up for a minimum of 5 years (mean, 76 months; range, 60-89 months), 37 patients (17.7%) had died with patent grafts and 121 (58%) grafts were occluded. Primary patency rate, measured with Kaplan-Meier survival analysis, was 46% (95% confidence interval [CI], 35%-57%) at year 5 for HBD, compared with 35% for PTFE (CI, 25%-45%; P < .055). Long-term patency was achieved in only 4 of 78 interventions performed in 55 thrombosed grafts. Secondary patency rate for HBD was 47% (CI, 36%-58%), and for PTFE was 36% (CI, 26%-46%). Risk factors for arterial disease did not significantly influence prosthetic patency. Major limb amputation was necessary in 9 patients with HBD grafts and 20 patients with PTFE grafts (P < .025). Two amputations in the HBD group and 8 amputations in the PTFE group were in patients undergoing bypass surgery to treat claudication only. Limb salvage rate was 86% (CI, 77%-95%) and 74% (CI, 64%-84%), respectively.Conclusions Significantly better patency rates were achieved with HBD than with PTFE at 3 years (P < .044), but the difference was no longer statistically significant at 5 years (P < .055). The incidence of major limb amputation, however, was significantly greater (P < .025) in the PTFE group compared with the HBD group at both 3 and 5 years of follow-up.

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Authors
Devine, C., & McCollum, C.
Affiliations
Wythenshawe Hospital (GB)
Corresponding author
McCollum, Charles
ORCID
McCollum, Charles
Venue
Journal of Vascular Surgery
Publisher
Elsevier BV
Published
2004-11
Volume
40
Issue
5
Pages
924-931
ISSN
0741-5214 (ISSN-L)
DOI
10.1016/j.jvs.2004.08.033
OpenAlex
W2139208533
Cited by
175
References
30
Citations by year
2026: 4 · 2025: 1 · 2024: 1 · 2023: 4 · 2022: 7 · 2021: 3 · 2020: 6 · 2019: 5 · 2018: 6 · 2017: 8 · 2016: 11 · 2015: 11 · 2014: 9 · 2013: 9 · 2012: 9
FWCI
10.77
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Vascular Surgery (publishedVersion)
  • PubMed (publishedVersion)
  • Research Explorer (The University of Manchester) (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Peripheral Artery Disease Management
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vascular Procedures and Complications
  • Health Sciences › Health Professions › Emergency Medical Services › Central Venous Catheters and Hemodialysis
Keywords
polytetrafluoroethylene graft, femoropopliteal bypass, graft occlusion, limb salvage, major amputation, peripheral arterial disease, claudication, aspirin, long-term outcomes, risk factors for graft failure, saphenous vein graft
MeSH terms
Adult, Aged, Aged, 80 and over, Anastomosis, Surgical, Aortography, Arterial Occlusive Diseases, Blood Vessel Prosthesis, Female, Femoral Artery, Follow-Up Studies, Graft Survival, United Kingdom, Heparin, Humans, Male, Middle Aged, Polyethylene Terephthalates, Polytetrafluoroethylene, Popliteal Artery, Probability, Prospective Studies, Prosthesis Design, Reference Values, Vascular Patency, Peripheral Vascular Diseases, Treatment Outcome, Risk Assessment, Blood Vessel Prosthesis Implantation, Coated Materials, Biocompatible

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