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


METHODS
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.
Devine
Carol
C
Department of Surgery, Wythenshawe Hospital, Manchester M23 9LT, England.
McCollum
Charles
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D001027:Aortography; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000601:surgery; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D020099:Coated Materials, Biocompatible; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006085:Graft Survival; D006493:Heparin / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000000981:diagnostic imaging / Q000601:surgery; D011093:Polyethylene Terephthalates; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000601:surgery*; D011336:Probability; D011446:Prospective Studies; D011474:Prosthesis Design; D012016:Reference Values; D018570:Risk Assessment; D016896:Treatment Outcome; D006113:United Kingdom; D014654:Vascular Patency / Q000502:physiology
D020099:Coated Materials, Biocompatible; D011093:Polyethylene Terephthalates; D011138:Polytetrafluoroethylene; D006493:Heparin