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

Area of Science:

• Vascular Medicine
• Pharmacology
• Patient Care

Background:

• Chronic limb-threatening ischemia (CLTI) presents challenges for patients unsuitable for revascularization.
• Iloprost is a potential pharmacological treatment for CLTI.
• This study compares home-based elastomeric pump iloprost (EP-iloprost) with hospital-based peristaltic pump iloprost (PP-iloprost).

Purpose of the Study:

• To evaluate the safety and effectiveness of EP-iloprost versus PP-iloprost in CLTI patients.
• To compare drug-related adverse events (AEs) and a composite of death and major amputations.
• To assess outcomes over a 1-year treatment period.

Main Methods:

• A cohort study comparing 56 patients receiving EP-iloprost with 48 patients receiving PP-iloprost.
• Follow-up duration was 3 years.
• Primary endpoint: incidence of drug-related AEs. Secondary endpoint: composite of all-cause death and major amputations.

Main Results:

• Fewer AEs occurred in the EP-iloprost group (14.3%) compared to the PP-iloprost group (31.3%), with a significantly lower exposure-adjusted incidence rate (8.3 vs 22.7 per 100 patient-years).
• Although cohorts differed in age, the EP-iloprost group showed fewer deaths (12.5% vs 22.9%) and major amputations (7.1% vs 27.1%) compared to the PP-iloprost group.

Conclusions:

• Low-rate home infusion of iloprost using an elastomeric pump appears better tolerated than high-rate hospital infusion.
• These findings suggest EP-iloprost may be a more effective treatment strategy for CLTI patients.
• Further hypothesis-generating data support home-based iloprost therapy.