Four years' results of a prospective, randomized clinical trial comparing polytetrafluoroethylene and modified human umbilical vein for below-knee femoropopliteal bypass

Jens H. Eickhoff, Albert Broomé, Björn F. Ericsson, Hans Jorgen Buchardt Hansen, Karl Frederik Kordt, Christian Mouritzen, Knut Kvernebo, Lars Norgren, Hans Rostad, Arne Trippestad

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Abstract

Polytetrafluoroethylene (PTFE) (Gore-Tex) and human umbilical vein (Biograft) arterial grafts were compared for below-knee femoropopliteal bypass grafting in a prospective randomized clinical trial. One hundred five patients (105 limbs) entered the trial. Seventy-six percent suffered from rest pain, ulceration, or gangrene. The median postoperative ankle-arm blood pressure index was 0.36. Twenty-three limbs had three patent tibial arteries, 46 limbs had two tibial arteries, 31 limbs had one patent artery, and five limbs had isolated popliteal segments. Thirty-four percent were repeat operations. Fifty-five patients were allocated to receive PTFE grafts and 50 to receive human umbilical vein grafts. The two groups were comparable as to preoperative risk factors and operative and postoperative treatment. During the first 4 years (maximum 1609 days) 40 PTFE graft and 24 umbilical veins occluded. At 1 year the PTFE patency rate was 53% and at 4 years was 22%. For umbilical vein the corresponding figures were 74% and 42% (p = 0.005, Gehan test). During follow-up the incidence of PTFE failure was on the average 2.1 times higher than that of umbilical vein failure (95% confidence limits 1.2 to 3.4).

Original languageEnglish (US)
Pages (from-to)506-511
Number of pages6
JournalJournal of Vascular Surgery
Volume6
Issue number5
DOIs
StatePublished - Nov 1987

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Umbilical Veins
Polytetrafluoroethylene
Knee
Extremities
Randomized Controlled Trials
Tibial Arteries
Transplants
Gangrene
Ankle
Arm
Arteries
Blood Pressure
Pain
Incidence

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

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Four years' results of a prospective, randomized clinical trial comparing polytetrafluoroethylene and modified human umbilical vein for below-knee femoropopliteal bypass. / Eickhoff, Jens H.; Broomé, Albert; Ericsson, Björn F.; Hansen, Hans Jorgen Buchardt; Kordt, Karl Frederik; Mouritzen, Christian; Kvernebo, Knut; Norgren, Lars; Rostad, Hans; Trippestad, Arne.

In: Journal of Vascular Surgery, Vol. 6, No. 5, 11.1987, p. 506-511.

Research output: Contribution to journalArticle

Eickhoff, Jens H. ; Broomé, Albert ; Ericsson, Björn F. ; Hansen, Hans Jorgen Buchardt ; Kordt, Karl Frederik ; Mouritzen, Christian ; Kvernebo, Knut ; Norgren, Lars ; Rostad, Hans ; Trippestad, Arne. / Four years' results of a prospective, randomized clinical trial comparing polytetrafluoroethylene and modified human umbilical vein for below-knee femoropopliteal bypass. In: Journal of Vascular Surgery. 1987 ; Vol. 6, No. 5. pp. 506-511.
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abstract = "Polytetrafluoroethylene (PTFE) (Gore-Tex) and human umbilical vein (Biograft) arterial grafts were compared for below-knee femoropopliteal bypass grafting in a prospective randomized clinical trial. One hundred five patients (105 limbs) entered the trial. Seventy-six percent suffered from rest pain, ulceration, or gangrene. The median postoperative ankle-arm blood pressure index was 0.36. Twenty-three limbs had three patent tibial arteries, 46 limbs had two tibial arteries, 31 limbs had one patent artery, and five limbs had isolated popliteal segments. Thirty-four percent were repeat operations. Fifty-five patients were allocated to receive PTFE grafts and 50 to receive human umbilical vein grafts. The two groups were comparable as to preoperative risk factors and operative and postoperative treatment. During the first 4 years (maximum 1609 days) 40 PTFE graft and 24 umbilical veins occluded. At 1 year the PTFE patency rate was 53{\%} and at 4 years was 22{\%}. For umbilical vein the corresponding figures were 74{\%} and 42{\%} (p = 0.005, Gehan test). During follow-up the incidence of PTFE failure was on the average 2.1 times higher than that of umbilical vein failure (95{\%} confidence limits 1.2 to 3.4).",
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