Below Knee Angioplasty Using Drug-Eluting Balloons in Patients with Critical Limb Ischemia with Six Months Follow-Up: Single-Center Experience at Tertiary Care Hospital

Abstract

Purpose The aim of this study was to evaluate 6 monthly safety and primary patency rates of drug-eluting balloons (DEB) angioplasty in below-the-knee (BTK) arteries in critical limb ischemia (CLI) patients.

Methods A prospective observational study was conducted over 2 years in a tertiary care center. A total of 25 patients with CLI were enrolled in this study. Inclusion criteria were patients presenting with CLI (Rutherford class 4 or greater), equal to or more than 50% luminal stenosis or occlusion of at least one tibial artery, and agreement to 6-month evaluation. Exclusion criteria were life expectancy less than 1 year, allergy to paclitaxel, and contraindication to antiplatelet treatment.

Follow-up was performed by clinical and Doppler assessment. The primary endpoint was a 6-month primary patency rate, and secondary endpoints were changes in the Rutherford class and incidence of major amputation. Restenosis rate is defined as a reduction in the luminal diameter by 50% or greater by duplex ultrasound.

Results Six-month primary patency was achieved in 19 (76%) patients. Both Rutherford category improvement and reduction in the percentage of stenosis after angioplasty were statistically significant (p-value <0.0001). At 6 months, better patency rates were seen among diabetics (88.8%) than smokers (69.2%). Limb salvage was observed in 24 (96%) patients with one major amputation (above the ankle).

Conclusion DEBs have shown safe and promising clinical outcomes with successful performance in infrapopliteal arteries in the short-term follow-up. DEB had a substantial 6-month primary patency rate. DEB angioplasty is a safe and effective treatment option for CLI patients with BTK vascular disease.

Keywords

drug-eluting balloon angioplasty - Below knee angioplasty - critical limb ischemia

Financial Support and Sponsorship

Nil.

Informed Consent

Written informed consent was obtained from all patients for publication of this clinical data and any accompanying images.

Publication History

Article published online:
14 October 2022

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