The Efficacy of Alprostadil as an Adjuvant Therapy with Indirect Angiosomal Revascularization in Patients with Critical Limb Ischemia after Failure of Direct Revascularization

Background: This study assesses the effectiveness of alprostadil (Prostaglandin E1) as an adjunct therapy alongside indirect angiosomal revascularization for patients with critical limb ischemia (CLI) after failed direct revascularization. CLI, particularly in cases of infrainguinal peripheral arterial disease, poses significant treatment challenges, necessitating innovative approaches to enhance outcomes. Methods: Between November 2018 and November 2020, 120 patients with CLI resulting from infrainguinal arterial disease were enrolled following unsuccessful direct revascularization. The cohort included 72 males and 48 females with a mean age of 63.41±12.52 years. Patients were monitored for 2 to 2.5 years based on diabetes status. Post-endovascular intervention, alprostadil was administered intravenously at 40 µg in 100 mL saline over 2 hours every 12 hours for six days. Outcomes, including the Ankle-Brachial Index (ABI) and vessel patency, were evaluated pre- and post-treatment. Results: The baseline mean ABI of 0.45±0.175 improved to 0.65±0.216, with a mean increase of 0.2±0.041 (P = 0.08, significant). Primary vessel patients were 93.3% at 1 month, and 92.9% at 3 and 6 months. The distribution of patent leg vessels improved, with the no-runoff-vessels group decreasing from 16.7% to 6.67% and the two-runoff-vessels group increasing from 16.7% to 33.3%. Conclusion: Alprostadil effectively improved vascular patency and clinical outcomes in patients with CLI and tissue loss, supporting its use as a safe adjuvant therapy.