Outcome of Prostaglandin E1 Therapy in Critical Lower Limb Ischemia

TL;DR

This study shows that PGE1 therapy can relieve pain and improve healing in patients with severe leg blood flow issues when surgery is not an option.

Contribution

The study provides evidence of PGE1's effectiveness in CLI management in a resource-limited setting.

Findings

92.4% of patients reported improvement in claudication after PGE1 therapy.

81% of patients experienced relief from rest pain.

71.4% of patients avoided amputation following treatment.

Abstract

Introduction: Critical lower limb ischemia (CLI) is a severe manifestation of peripheral arterial disease, often progressing to pain, tissue loss, and amputation when blood flow is critically compromised. As many patients are unsuitable for revascularization, prostaglandin E1 (PGE1) has emerged as a potential therapy to improve perfusion, relieve symptoms, and promote healing. This study evaluated the outcomes of intravenous PGE1 therapy at two major centers in Bangladesh, aiming to improve patients' quality of life.

Methodology: This observational study was conducted over a 12-month period in the vascular surgery departments of Bangladesh Medical University (BMU) and the National Institute of Cardiovascular Diseases (NICVD). The study population comprised patients with CLI receiving PGE1 therapy, selected through convenience sampling. Using a sample size calculation based on a prevalence rate of 7.5% for CLI, a total of 105 patients were included in the study. The inclusion criteria focused on patients aged 40 years or older with below-knee disease who were unsuitable for surgical intervention or had experienced failed revascularization. Exclusion criteria ruled out individuals with acute limb ischemia, vasculitis, aorto-iliac lesions, abdominal aortic aneurysms, or low cardiac function. All demographic and clinical information was documented in individual case record forms, and the compiled data were subsequently analyzed using appropriate statistical methods.

Results: The results of this study revealed important insights into the demographic and clinical characteristics of patients undergoing PGE1 therapy for CLI. Patients aged 70 years and above represented the largest group at 32.4%, with a predominance of male patients (90.5%) and a significant portion from lower socioeconomic backgrounds (76.2%). A substantial majority of patients were smokers (81%) and were nearly evenly split between diabetic and non-diabetic (48.6% and 51.4%, respectively). Hypertension and dyslipidemia were common comorbidities, affecting 57.1% and 47.6% of the cohort, respectively. A striking 93.3% of patients experienced rest pain, and 41.9% presented with ulceration. Despite the severity of the condition, PGE1 therapy demonstrated encouraging results, with 92.4% of patients reporting improvements in claudication, 81% experiencing relief from rest pain, and 56.2% showing ulcer healing. Only 5.7% of patients saw improvements in their ankle-brachial pressure index (ABPI). Around 71.4% of the cohort avoided amputation, and the in-hospital mortality rate was 8.4%, highlighting PGE1’s potential to improve patient outcomes in CLI.

Conclusions: PGE1 therapy showed meaningful clinical benefit in patients with CLI by relieving pain, improving claudication, promoting ulcer healing, and supporting limb salvage, even when objective perfusion gains were limited. These findings underscore its value as a practical therapeutic option in resource-limited settings and highlight the need for further studies to refine and optimize treatment strategies.