Effects of adjuvant PGE1 therapy following profundaplasty in patients with severe limb ischaemia. Early and long-term results.
BACKGROUND
In patients with peripheral arterial occlusive disease (PAOD) 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 intravenous prostaglandin E1 (PGE1) treatment in patients undergoing profundaplasty.


METHODS
A prospective randomized placebo-controlled study was conducted in 83 patients with PAOD of the lower extremities (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 PGE1 group (n = 42) received twice daily a 2-hour intravenous infusion of 60 micrograms PGE1 in 250 ml of physiological saline. Patients of the control group (n = 41) were given only saline by the same regimen. Following discharge from hospital, patients 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 PGE1 group, rest pain disappeared and necrotic lesions healed in a significantly larger proportion of patients as compared with the control group (62% vs 37%; p = 0.05). Moreover, the number of minor amputations, such as toe and forefoot amputations, was significantly smaller in patients treated with PGE1 (7 vs. 19; p < 0.001). Long-term results: By the end of the 5-year follow-up period, a significantly larger percentage of patients was still alive in the PGE1 group as compared with control (55% vs. 34%; p = 0.046). Moreover, significantly less major amputations became necessary during follow-up in the PGE1 group (8 vs. 16; p = 0.0088).


CONCLUSIONS
In patients undergoing profundaplasty because of severe limb ischemia due to three-level occlusion, adjuvant intravenous 3-week treatment with PGE1 substantially improves not only the short-term results, but also the long-term outcome after five years in terms of patient survival and limb salvage.
Gruss
J D
JD
Department of Vascular Surgery, Kurhessisches Diakonissenhaus, Kassel.
D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage*; D000671:Amputation, Surgical; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D001807:Blood Vessel Prosthesis; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007511:Ischemia / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D011446:Prospective Studies; D012086:Reoperation
D000527:Alprostadil