Evaluation of a conservative treatment with iIoprost in severe peripheral occlusive arterial disease (POAD) : GISAP study

GISAP a multicentre open study was aimed to confirm the feasibility and safety of iloprost treatment in normal clinical practice and to identify subgroups of patients with severe POAD more likely to benefit from iloprost treatment than others. One hundred forty six patients were treated at the maximum tolerated dose of iloprost up to 2 ng/kg/min, 6 hours infusion per day, for a minimum of 3 weeks and a maximum of 8 weeks. Clinical efficacy was assessed by rest pain reduction, analgesic consumption, healing of trophic lesions, walking ability. A significant improvement of the efficacy parameters was recorded during and at the end of treatment: no difference between diabetics and non diabetics, stage III and IV patients was observed. After one year follow-up 10% major amputation and 6.8% death were recorded, these events were balanced between the diabetic and non diabetic patients. Overall 80% of the patients at risk of amputation at entry to the trial were alive with a viable limb after one year. Tolerability resulted quite acceptable. Even with the limitation of an open trial, it has been confirmed the therapeutic potential of iloprost in the treatment of POAD patients.