Dacron or PTFE for above-knee femoropopliteal bypass. a multicenter randomised study.
OBJECTIVE
To compare polytetrafluorethylene (PTFE) and polyester grafts (Dacron) for above knee femoropopliteal bypass.


METHODS
Multicenter randomised clinical trial.


METHODS
427 patients were randomised between 6mm Dacron (Uni-Graft, B. Braun Melsungen AG, 34212 Melsungen, Germany) and PTFE (Goretex, W. L. Gore & Ass. Inc., Newark DE 19711, USA) above-knee femoropopliteal bypass grafts within 13 centres in Denmark (n=261), Norway (n=113) & Finland (n=53) between 1993 and 1998. Fourteen (3%) patients were excluded, leaving 413 patients with 208 Dacron and 205 PTFE grafts for analysis. Age, gender, indication (claudication: 65%), run-off (2 or 3 vessels: 76%), diabetes (17%) and hypertension (31%) as well as cerebrovascular (9%) and cardiac (33%) risks were evenly distributed. Patients were followed postoperatively at 1, 12 and 24 months. Patency assessment was based on ankle-brachial pressures or imaging in case of doubt.


RESULTS
The two-year primary patency rates for Dacron and PTFE were 70% and 57% (p=0.02), whereas the secondary patency rates were 76% and 65% (p=0.04), respectively. Primary patency at two years was significantly influenced by the number of patent crural vessels (two or three 67%, one 50%, p=0.01). Amputations at two years, major in 4% and minor in 3%, 30-days mortality and complications (wound infections: 3% and other wound complications: 13%) occurred equally frequent in both groups. At two years, patients treated for critical limb ischemia had a major amputation more often than patients operated on for intermittent claudication, 10 and 3 respectively (p=0.003), and had higher mortality rates, 20% and 8% respectively (p=0.001).


CONCLUSIONS
This trial confirms that Dacron is at least as durable as PTFE for above-knee bypass procedures, and might even be superior.
Jensen
L P
LP
Department of Vascular Surgery B, Copenhagen University Gentofte Hospital, , Copenhagen, Denmark. ljp@dadlnet.dk
Lepäntalo
M
M
Fossdal
J E
JE
Røder
O C
OC
Jensen
B S
BS
Madsen
M S
MS
Grenager
O
O
Fasting
H
H
Myhre
H O
HO
Baekgaard
N
N
Nielsen
O M
OM
Helgstrand
U
U
Schroeder
T V
TV
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011093:Polyethylene Terephthalates; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D011474:Prosthesis Design; D012189:Retrospective Studies; D016896:Treatment Outcome; D014463:Ultrasonography; D014654:Vascular Patency
D011093:Polyethylene Terephthalates; D011138:Polytetrafluoroethylene