Home-based intravenous iloprost by portable elastomeric pump in chronic limb-threatening ischemia: A pilot study.

BACKGROUND: Iloprost has been proposed as a pharmacological option for patients with chronic limb-threatening ischemia (CLTI) in whom revascularization is either not feasible or has been unsuccessful. This pilot study aimed to evaluate the safety and effectiveness of intravenous iloprost at low infusion rates via an elastomeric pump at home (EP-iloprost) versus higher infusion rates via a peristaltic pump in the hospital (PP-iloprost) for 1 year.

METHODS: This was a cohort study conducted in 'no-option' patients for revascularization with CLTI. The follow-up was 3 years. The primary endpoint was the incidence of drug-related adverse events (AEs); the secondary outcome was the composite of all-cause death and major amputations.

RESULTS: We enrolled 56 patients who received EP-iloprost as a pilot study. Their outcomes were compared with a cohort of 48 patients who had received PP-iloprost. AEs were reported in 15 (31.3%) patients who received PP-iloprost and in eight (14.3%) who received EP-iloprost (p = 0.038), with the exposure-adjusted incidence rate being 22.7/100 patient-years in the PP-iloprost group and 8.3/100 patient-years in the EP-iloprost group. Although the two cohorts were not well-suited for comparison due to age differences, there were seven (12.5%) deaths and four (7.1%) major amputations in the EP cohort compared with 11 (22.9%) deaths and 13 (27.1%) major amputations in the PP cohort.

CONCLUSIONS: These hypothesis-generating data suggest that low-rate infusion of EP-iloprost at home is better tolerated and potentially more effective than high-rate infusion with PP in a hospital setting.