Preliminary experience with defibrotide in severe lower limb ischaemia.

Eight patients with severe lower limb ischaemia, aged 65-80, received defibrotide intravenously for periods from 5 to 21 days (mean 13 days). All patients had intractable rest pain. Five had ischaemic ulcers and 3 had minor gangrene. Five had previous arterial surgery and 6 lumbar sympathetic ganglion injections. Pretreatment ankle pressure indices ranged from 0 to 0.5 (mean 0.19). Rest pain, sleep disturbance and analgesic requirement were assessed on a nominal scale. Rest pain improved in 4 and sleeping pattern in 2 patients. One patient showed a diminution in analgesic requirement. Pressure indices improved in 5 patients. Amputation was performed in 4 patients. Adverse reactions included vomiting and diarrhoea (2), thrombophlebitis at infusion site (3) and generalized skin reaction (1). All patients had 'end-stage' peripheral vascular disease but some showed symptomatic benefit. Further evaluation of defibrotide is indicated.