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

Q: What are the key findings of this study?

Home-based 24-hour intravenous iloprost via elastomeric pump lowered drug-related adverse events vs 6-hour hospital infusion in no-option CLTI (14.3% vs 31.3%; adjusted HR 0.39, p=0.040).

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Chronic limb-threatening ischemia (CLTI) (n=104). Intervention: Home-based intravenous iloprost via portable elastomeric pump (EP-iloprost) vs. Hospital-based intravenous iloprost via peristaltic pump (PP-iloprost, 50 μg in 250 mL saline over 6 hours). Primary outcome: Incidence of iloprost-related adverse events (AEs) (HR 0.39, 95% CI 0.16-0.96, p=0.040).

Q: What does this research mean for the field?

Continuous low-rate intravenous iloprost infusion via an elastomeric pump at home reduces drug-related adverse events compared with intermittent high-rate hospital infusion in patients with chronic limb-threatening ischemia. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Michelangelo Sartori; Elisabetta Favaretto; Elisa Zanata; Sofia Cavara; Alessia Libra; Alessia Sonetto; Enrico Gallitto; Mauro Gargiulo; Benilde Cosmi

doi:10.1177/1358863x261447258

June 23, 2026Vascular Medicine

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

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Key result

Home-based continuous iloprost linked to ~61% lower adverse events vs hospital infusion in CLTI.

HR 0.39
95% CI 0.16-0.96
P=0.040
n=104

Figures

Why the study?

Does home-based low-rate 24-hour intravenous iloprost infusion via an elastomeric pump reduce drug-related adverse events and improve amputation-free survival compared with hospital-based 6-hour infusion via a peristaltic pump in 'no-option' patients with chronic limb-threatening ischemia?

Key Points

To evaluate the safety and effectiveness of low-rate intravenous iloprost delivered at home via an elastomeric pump compared with higher-rate infusion via a hospital peristaltic pump over 1 year in patients with chronic limb-threatening ischemia.
A cohort study enrolled 104 patients with chronic limb-threatening ischemia ineligible for revascularization, assigning 56 patients to home-based continuous elastomeric pump infusion and 48 patients to hospital-based peristaltic pump infusion.
Patients were monitored over a 3-year follow-up period for drug-related adverse events (primary endpoint) and a composite secondary endpoint of all-cause death and major amputations.
Drug-related adverse events occurred in 14.3% (8/56) of the elastomeric pump group versus 31.3% (15/48) of the peristaltic pump group (p = 0.038), with adjusted adverse event-free survival favoring the elastomeric pump (HR 0.39, 95% CI: 0.16–0.96; p = 0.040).
Exposure-adjusted adverse event incidence rates were 8.3/100 patient-years (95% CI: 4.2–15.4) for elastomeric pump infusion compared with 22.7/100 patient-years (95% CI: 14.3–34.2) for peristaltic pump infusion.
All-cause death occurred in 12.5% (7/56) versus 22.9% (11/48) and major amputations occurred in 7.1% (4/56) versus 27.1% (13/48) in the elastomeric and peristaltic cohorts, respectively, with elastomeric delivery predicting lower composite risk on multivariable analysis (HR 0.41, 95% CI: 0.19–0.88; p = 0.022).

Study Design

Type

Cohort (n=104)

Blinding

Open-label

Multicenter

No

Structured PICO

Does home-based low-rate 24-hour intravenous iloprost infusion via an elastomeric pump reduce drug-related adverse events and improve amputation-free survival compared with hospital-based 6-hour infusion via a peristaltic pump in 'no-option' patients with chronic limb-threatening ischemia?

P

Population

104 'no-option' patients with chronic limb-threatening ischemia (mean age 68.7 years, 43.3% female) and limited tissue loss (WIfI wound <3), followed for up to 3 years.

E

Exposure

Home-based intravenous iloprost via portable elastomeric pump (EP-iloprost, n=56): 50 ug iloprost (67 ug iloprost trometamol) diluted in 100 mL saline infused over 24 hours, administered 3 times per week for the first 1-2 months, then reduced to once weekly for 10 months (total 1 year) or until ulcer healing/pain resolution, alongside background therapy (statin plus ezetimibe, aspirin or clopidogrel, and low-dose rivaroxaban 2.5 mg BID plus aspirin from Dec 2020 if eligible).

C

Comparator

Hospital-based intravenous iloprost via peristaltic pump (PP-iloprost, n=48): 50 ug iloprost (67 ug iloprost trometamol) diluted in 250 mL saline infused over 6 hours (0.5-2.0 ng/kg/min, target 40 mL/h), administered 3 times per week for the first 1-2 months, then reduced to once weekly for 10 months (total 1 year) or until ulcer healing/pain resolution, on the same background medical therapy.

O

Outcome

Incidence and exposure-adjusted incidence rate of iloprost-related adverse events (AEs) over 3 years of follow-up (measured by direct nurse observation in the hospital PP group and indirect patient self-reporting in the home EP group).safety

Main Result

Hazard Ratio: 0.39 (95% CI 0.16–0.96)

Absolute Event Rate: 14.3% vs 31.3%

p-value: p=0.040

In 'no-option' CLTI patients, 24-hour home-based intravenous iloprost infusion via an elastomeric pump demonstrated significantly fewer drug-related adverse events and a signal toward lower mortality and major amputation compared with 6-hour hospital-based peristaltic pump infusion, supporting feasibility for future randomized trials.

Limitations

Small sample size (pilot study)
Non-randomized cohort design leading to selection bias
Significant age difference between groups (PP group was older by 6 years on average)
Higher use of rivaroxaban in the EP-iloprost group
Indirect measurement of treatment adherence and self-reporting of adverse events at home
Non-randomized cohort design leading to selection and confounding biases, notably a 6-year mean age difference between groups (PP group was significantly older)
Imbalanced use of rivaroxaban and thromboangiitis obliterans prevalence between groups
Indirect measurement of treatment adherence in the home-based EP group, which may overestimate adherence
Potential underreporting of adverse events occurring at home in the EP group

Implication

Home-based low-rate iloprost was associated with fewer drug-related adverse events in no-option CLTI; hypothesis-generating and requires randomized confirmation.

Abstract

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. 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.

Discussion

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Cite This Study

Sartori et al. (2026) conducted a cohort in Chronic limb-threatening ischemia (CLTI) (n=104). Home-based intravenous iloprost via portable elastomeric pump (EP-iloprost) vs. Hospital-based intravenous iloprost via peristaltic pump (PP-iloprost, 50 μg in 250 mL saline over 6 hours) was evaluated on Incidence of iloprost-related adverse events (AEs) (HR 0.39, 95% CI 0.16-0.96, p=0.040). Home-based 24-hour intravenous iloprost via elastomeric pump lowered drug-related adverse events vs 6-hour hospital infusion in no-option CLTI (14.3% vs 31.3%; adjusted HR 0.39, p=0.040).

synapsesocial.com/papers/6a3c230ed15afadd906f9c80 https://doi.org/10.1177/1358863x261447258

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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