Purpose: To assess the efficacy and of iloprost in the treatment of Buerger’s disease.
Methods: In this prospective study, 158 patients with rest pain and/or ischemic ulcers from 17 clinics were administered 1 ng/kg/min intravenous iloprost for 28-days. The primary endpoint was complete healing without pain or major amputation at 24 weeks. The secondary endpoints were pain assessment, reduction in ulcer area, 50% reduction of the ulcer size, shift in the modified SVS/ISCVS clinical status grading scale, global assessment by the investigator and an independent observer at 4 and 24 weeks. The comparisons were carried out with the initial values. The final evaluation was carried out in 150 patients.
Results: Complete healing rate was significantly better with iloprost treatment in comparison to the initial values at 24 weeks (<0.001). The secondary endpoints; complete healing rate, pain, the size of the ulcer, 50% reduction of the ulcer size, SVS/ISCVS grading scale, assessment by investigator, assessment by observer parameters were significantly better at 4 and 24 weeks (<0.001). The reduction of the ulcer size was significantly better when comparing 4th and 24th week values (<0.05).
Conclusion: The results of this independent study indicate that intravenous iloprost relieves ischemic symptoms efficiently in the acute phase Buerger’s disease patients. Considering unsatisfactory results following surgical revascularisation and sympathectomy in Buerger’s disease, prostacyclin analogues might be the first line treatment as long as complete abstinence from smoking is achieved.