Methods: Sixty patients with critical leg ischemia were randomly assigned to receive either iloprost trometamol concomitant with a six-month course of cilostazol (group 1, n=30) or standard treatment with iloprost trometamol (group 2, n=30). The primary endpoints were changes in ankle-brachial index, walking distance, and score changes in the visual analog scale, and limb preservation at 24 weeks. The secondary endpoints were re-hospitalization requirement and the amount of analgesics used.

Results: There was a mean increase of 12% and 5.14% in the anklebrachial index in group 1 and 2, respectively (p<0.05). Maximum walking distance at baseline and at 24 week were as follows: Group 1 baseline 43.1 m, group 2 baseline 43.5 m (p>0.05), group 1 at 24 week 75.1 m, group 2 at 24 week 63.8 m (p>0.05). The mean change in maximum walking distance in groups was 32 m (74.2%) increase from the baseline distance in group 1 and 20.3 m (46.6%) in group 2 (p<0.05). The visual analog scale scores at baseline were 8.4 in group 1 and 8.3 in group 2 (p>0.05). Twenty four-week control values were reduced to 3.5 and 5.2, respectively (p<0.05). One patient underwent digital amputation in group 2. After a 24-week period, seven patients in group 1 were using analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs (NSAID). Six patients in group 2 required re-hospitalization.

Conclusion: The treatment of critical leg ischemia with iloprost trometamol plus cilostazol combination therapy exhibited better results, compared to iloprost trometamol monotherapy. The combination therapy is promising in terms of the symptomatic relief and improved quality of life of the patients. This therapeutic regimen should be considered in patients in whom percutaneous intervention or revascularization are not possible.