[Effect of buflomedil perfusion on peripheral tissue oxygenation during transluminal angioplasty in patients with advanced arteriopathy of the lower limbs].

Randomized double-blind placebo controlled trial performed in two parallel groups of patients, aged 43 to 92, suffering from advanced arterial disease of the lower limbs to be treated with angioplasty. The aim was to compare the efficacy of infusions of buflomedil with placebo on peripheral tissue oxygenation following lower limb angioplasties. Treatments consisted of 3 hour infusion of buflomedil or isotonic saline combined with arterial disobstruction. The major outcome measures were transcutaneous oxygen tension (TCpO2) correlated to ankle systolic pressure index (SPI). An increase of TCpO2 values (p < 0.01) as well as the mean individual variations of TCpO2 (p < 0.05) before and after angioplasty were observed in the buflomedil-treated group, whereas SPI values varied similarly in both groups. No adverse event was shown. In conclusion, buflomedil infusions during angioplasties of the lower limbs may improve tissue oxygenation subsequent to arterial disobstruction and are well tolerated.