Effects of iloprost on pain-free walking distance and clinical outcome in patients with severe stage IIb peripheral arterial disease: the FADOI 2bPILOT Study.

ABSTRACT

BACKGROUND: Patients with peripheral arterial disease (PAD) at stage IIb, pain-free walking distance (PFWD) less than 100 m and unsuitable for revascularization have both impaired quality of life and severe clinical outcome. Aim of the study was to evaluate the efficacy of the prostacyclin analogue iloprost, added to standard therapy, in these patients. MATERIAL AND METHODS: Patients were randomized to receive standard medical therapy (Group A) or standard therapy plus iloprost (Group B), for 1 year. Iloprost was administered for 10 days every 3 months. Treadmill test was performed every 3 months, in Group B before starting the 10-day iloprost cycle. RESULTS: Fifty patients in Group A and 51 in Group B were enrolled. Mean baseline and 12-month PFWD values were 75.4 ± 21.3 and 128.9 ± 62.9 for iloprost group and 70.3 ± 21.6 and 99.6 ± 62.6 m for controls. Patients treated with iloprost had significantly higher PFWD at 9 and 12 months. This finding was confirmed after carrying forward the last valid observation (124.7 ± 63.4 vs. 88.4 ± 63.1 m, P < 0.01). Major cardiovascular events occurred in 32.0% and 3.9% of patients in Group A and Group B, respectively (P < 0.001). Five patients in Group A died vs. none in Group B (P = 0.02). No serious unexpected adverse reactions occurred in patients receiving iloprost. CONCLUSIONS: Iloprost, added to standard therapy, significantly increases exercise capacity in patients with PAD at severe stage IIb. The percentage of patients who died or experienced major cardiovascular events was significantly lower in patients receiving iloprost. Future studies should focus on the effects of this therapy on clinical outcome.