EFFECTS OF PERIOPERATIVE ILOPROST ON PATENCY OF FEMORODISTAL BYPASS GRAFTS

Objective: To investigate the effect of a 3 day perioperative iloprost regimen on the patency of femorodistal bypass grafts. Design: Prospec tive, randomised, placebo-controlled study. Setting: Twenty-one specia lised vascular surgical centres in Northern Europe. Subjects and treat ments: Preoperatively 528 patients undergoing femorodistal bypass surg ery were randomised to receive either iloprost or placebo intravenousl y at the beginning of the operation and in three daily 6 h infusions p ostoperatively with an intragraft injection given on completion of the bypass procedure. Chief outcome measures: Patency, surgical intervent ions and clinical outcome were recorded in all cases for 12 months aft er bypass. Results: Five hundred and seventeen patients received a byp ass as planned and were evaluable. The graft material was vein in 424 cases (82%) and prosthetic or partly prosthetic in 92 (18%). Overall p rimary patency rates at 12 months were 52.0% for vein grafts and 45.1% for prosthetic grafts (p = 0.25). The effect of iloprost on primary p atency was not statistically significant at 12 months in either vein o r prosthetic grafts, but an early effect of improved patency in prosth etic grafts was seen over the first 3 days. Other results at the end o f follow-up were similar in both treatments groups: 105 patients (20.3 %) had been amputated, a further 85(16.4%) had died and 78 (15.1%) wer e still suffering from rest pain or trophic lesions. Two hundred and t hirty-eight patients (46.0%) were alive with both legs and either no s ymptoms or only intermittent claudication after 12 months. Conclusions : In the setting of this multicentre trial no long-term benefits from the use of a 3 day iloprost regimen were demonstrated Surprisingly sma ll differences were found between the outcomes of vein and prosthetic femorodistal bypass grafts.