EFFECTS OF ADJUVANT PGE(1) THERAPY FOLLOWING PROFUNDAPLASTY IN PATIENTS WITH SEVERE LIMB ISCHEMIA - EARLY AND LONG-TERM RESULTS

Background: In patients with peripheral arterial occlusive disease (PA OD) of stage III/IV and three-level occlusion, the outcome of vascular surgery is still unsatisfactory. Therefore, the aim of our study was to determine both the short-term results and the long-term outcome, in terms of limb salvage and patient survival, of adjuvant iintravenous prostaglandin E-1 (PGE(1)) treatment in patients undergoing profundapl asty. Patients and methods: A prospective randomized placebo-controlle d study was conducted in 83 patients with PAOD of the lower extremitie s (stage III or IV according to Fontaine). Profundaplasty was carried out in all patients. Starting on the day of surgery and continuing for three weeks, patients of the PGE(1) group (n = 42) received twice dai ly a 2-hour intravenous infusion of 60 mu g PGE(1) in 250 ml of physio logical saline. Patients of the control group (n = 41) were given only saline by the same regimen. Following discharge from hospital, patien ts were re-examined after 6 weeks and subsequently every 6 months for a period of up to 5 years. Results: Short-term results: In the PGE(1) group rest pain disappeared and necrotic lesions healed in a significa ntly larger proportion of patients as compared with the control group (62% vs. 37%; p = 0.05). Moreover the number of minor amputations, suc h as toe and forefoot amputations, was significantly smaller in patien ts treated with PGE(1) (7 vs. 19; p < 0.001). Long-term results: By th e end of the 5-year follow-up period a significantly larger percentage of patients was still alive in the PGE(1) group as compared with cont rol (55% vs. 34%; p = 0.0461). Moreover, significantly less major ampu tations became necessary during follow-up in the PGE(1) group (8 vs. 1 6; p = 0.0088). Conclusions: In patients undergoing profundaplasty bec ause of severe limb ischemia due to three-level occlusion, adjuvant in travenous 3-week treatment with PGE(1) substantially improves not only the short-term results, but also the long-term outcome after five yea rs in terms of patient survival and limb salvage.