Effects of perioperative iloprost on patency of femorodistal bypass grafts. The Iloprost Bypass International Study Group.

OBJECTIVE

To investigate the effect of a 3 day perioperative iloprost regimen on the patency of femorodistal bypass grafts.

DESIGN

Prospective, randomised, placebo-controlled study.

SETTING

Twenty-one specialised vascular surgical centres in Northern Europe. SUBJECTS AND TREATMENTS: Preoperatively 528 patients undergoing femorodistal bypass surgery were randomised to receive either iloprost or placebo intravenously at the beginning of the operation and in three daily 6 h infusions postoperatively with an intragraft injection given on completion of the bypass procedure.

CHIEF OUTCOME MEASURES

Patency, surgical interventions and clinical outcome were recorded in all cases for 12 months after bypass.

RESULTS

Five hundred and seventeen patients received a bypass as planned and were evaluable. The graft material was vein in 424 cases (82%) and prosthetic or partly prosthetic in 92 (18%). Overall primary 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 patency was not statistically significant at 12 months in either vein or prosthetic grafts, but an early effect of improved patency in prosthetic grafts was seen over the first 3 days. Other results at the end of 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%) were still suffering from rest pain or trophic lesions. Two hundred and thirty-eight patients (46.0%) were alive with both legs and either no symptoms 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 small differences were found between the outcomes of vein and prosthetic femorodistal bypass grafts.