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...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Thieme Medical and Scientific Publishers Pvt. Ltd.
2022-12-01
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| Series: | Journal of Clinical Interventional Radiology ISVIR |
| Subjects: | |
| Online Access: | http://www.thieme-connect.de/DOI/DOI?10.1055/s-0042-1757580 |
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| 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. |
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| ISSN: | 2456-4869 |