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

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...

Full description

Saved in:
Bibliographic Details
Main Authors: Jawahar Rathod, Virender Sheorain, Shivprasad Jaybhay, Rajjat Shaikh, Pratik Bangde
Format: Article
Language:English
Published: Thieme Medical and Scientific Publishers Pvt. Ltd. 2022-12-01
Series:Journal of Clinical Interventional Radiology ISVIR
Subjects:
Online Access:http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-1757580
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:2456-4869