Prostacyclin treatment of ischemic ulcers and rest pain in unreconstructible peripheral arterial occlusive disease.

The efficacy of prostacyclin (PGI2) treatment was assessed in 26 patients with surgically unreconstructible atherosclerotic arterial occlusive disease of the lower extremity manifested by nonhealing ulcers and rest pain. Patients were randomized to receive a 72-hour intravenous infusion of PGI2 (6 ng/kg/min, n = 13) or placebo (n = 13). Ulcer size was measured by photographic planimetry, and rest pain was graded by blinded objective scoring at monthly intervals for 6 months. Ulcer size increased 64% in PGI2-treated patients and 22% in placebo-treated patients by 1 month after infusion. Rest pain decreased slightly in both PGI2 and placebo groups. At the conclusion of the study, 54% of placebo-treated patients and 31% of PGI2-treated patients had a positive treatment response, indicated by at least a 20% decrease in ulcer size and a 33% decrease in rest pain. PGI2 infusion did not improve the high-placebo response rate seen in these patients with severely ischemic extremities. These results emphasize the importance of placebo-controlled studies, even in patients with unreconstructible arterial disease.