Ann Surg Treat Res.  2021 Aug;101(2):120-128. 10.4174/astr.2021.101.2.120.

Multiple drug-coated balloons can be used effectively for peripheral arterial disease including long femoropopliteal lesions

• Chu W
• Kim DH
• Kwon S
• Park Jh
• Jung HJ
• Lee SS

• KMID: 2519005
• DOI: http://doi.org/10.4174/astr.2021.101.2.120

Abstract

Purpose
Drug-coated balloons have shown successful results in treating peripheral arterial occlusive disease. However, using multiple balloons for long femoropopliteal lesions (>15 cm) remains challenging; their safety and efficacy need to be explored. Therefore, we aimed to evaluate the outcomes of multiple drug-coated balloons for long femoropopliteal lesions in terms of the primary patency, freedom from clinically-driven target lesion revascularization, and mortality.
Methods
Between April 2015 and September 2018, 96 patients (117 limbs) who underwent balloon angioplasty using at least 2 drug-coated balloons for femoropopliteal lesions were retrospectively reviewed. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) classification C or D. The outcomes were analyzed using Kaplan-Meyer analysis.
Results
The mean age of 96 enrolled patients was 70.8 ± 9.8 years, and 83 patients were males (86.5%). Critical limbthreatening ischemia was found in 29 cases (24.8%). The mean lesion and drug-coated balloon lengths per limb were 292.3 ± 77.8 mm and 325.0 ± 70.2 mm, respectively. The technical success rate was 99.2%. A total of 82.1% were followedup for more than 6 months. The primary patency rates at 12 and 24 months were 71.4% and 41.7%, respectively; freedom from clinically-driven target lesion revascularization rates were 96.4% and 71.0% at 12 and 24 months, respectively. The Kaplan-Meier estimate of the 2-year overall cumulative mortality rate was 20.8%. All identified mortalities appeared to be less associated with paclitaxel.
Conclusion
Drug-coated balloons can be effectively used without drug-related mortality, even for long lesions, such as TASC classification C or D femoropopliteal lesions.

Keyword

Angioplasty; Arterial occlusive diseases,; Femoral artery; Mortality; Paclitaxel

Figure

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  Fig. 1 Estimated cumulative primary patency (A) and freedom from clinically-driven (CD) target lesion revascularization (TLR) rate (B) by Kaplan-Meier analysis.

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  Fig. 2 Scatter plot on the relationship between death and paclitaxel exposures. For paclitaxel dosage, refer to the manufacturer's instruction for use for each balloon.

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