Prevention of Reocclusion After Prosthetic Bypass Operations in the Femoro-Popliteal Region: A Comparative Study of Pentoxifylline Versus Acetylsalicylic Acid

Abstract

One hundred eighteen patients (88 males, 30 females, mean age 67.2 years, age range 42 to 87 years) with successfully performed synthetic prosthetic by pass operations in the femoro-popliteal area were submitted in an open random ized study of two groups of 59 subjects to oral treatment by 400 mg pentoxifylline in special patented slow-release formulation or 500 mg ASA tid from two days before operation until twelve months after operation (with par enteral administration of both drugs on the day of surgery and two days after surgery). Effectiveness of prevention of reocclusion was assessed by patency rates and drug tolerability.

The examinations (clinical status, pulse palpation, Doppler-pressure mea surement, arteriography) were carried out before and on days five or six after operation, and also after three, six, nine, and twelve months of the follow-up period.

The life table analysis disclosed no significantly different patency rates (75% for the pentoxifylline-treated group and 74% for the ASA cohort).

A significantly superior tolerability was found in the patients treated with pentoxifylline, 6 patients (10%) reporting adverse reactions as compared with 33 (56%) in the ASA-treated group. The side effects consisted mostly of gastric upset, dizziness, and gastric hemorrhage. The medication was discontinued in 6 patients on pentoxifylline and 12 on ASA.