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A Review Of Drug-coated Balloon Technology For Peripheral Vascular Disease
Vy C. Dang1, Carly S. Filguiera, PhD
2, Maham Rahimi, MD, PhD
2.
1Texas A&M University School of Medicine, Bryan, TX, USA,
2Houston Methodist Hospital, Houston, TX, USA.
OBJECTIVES: Drug-coated balloon (DCB) technology began as an alternative to drug-eluting stents (DES) for treatment of below the knee (BTK) peripheral arterial disease (PAD). Unlike percutaneous transluminal angioplasty (PTA) using an uncoated balloon, DCB technologies are coated with antiproliferative agents (e.g., paclitaxel) that prevent neointimal hyperplasia and improve vessel patency. Over the past decade, the safety and efficacy of paclitaxel DCB for PAD has been questioned, with concern for increased risk of death, paclitaxel embolization, and an increased major amputation rate when compared to PTA. Here, we review literature around DCB technology, identify limitations of existing studies, and discuss future directions.
METHODS: A literature search was performed using the electronic database PubMed using the following terms: ([drug-coated balloon] OR [drug-eluting balloon]) AND ([below-the-knee] OR [BTK] OR [infrapopliteal]). Official brochures for specific DCBs released by pharmaceutical companies were reviewed along with accompanying clinical trials. Randomized controlled trials and meta-analyses evaluating the safety and efficacy of DCBs were prioritized; references were evaluated for relevance and inclusion.
RESULTS: IN.PACT
TM Amphirion, Lutonix® 014, and Passeo-18 Lux DCBs have been compared to PTA in BTK revascularization. Efficacy was evaluated with rates of target lesion revascularization (TLR), and safety was evaluated with rates of all-cause mortality, TLR, and major target extremity amputation. IN.PACT
TM Amphirion versus PTA at 12 months demonstrated comparable TLR (9.0% vs. 13.1%; p=0.291) and mortality (39.4% vs 44.9%; p=0.727) but increased amputation (8.8% vs 3.6%; p=0.080) rates. Lutonix® 014 versus PTA at 12 months demonstrated 76.8% freedom from TLR and a 94.8% freedom from amputation. Passeo-18 Lux versus PTA at 12 months demonstrated comparable TLR (31.3 vs. 26.9; p=0.805), mortality (9.4 vs. 6.0; p=0.575), and amputation (3.3% vs. 5.6%; p=0.631) rates. Limitations of the existing literature are attributed to the high heterogeneity of treatment and control groups. Variables such as balloon design and polymer, excipients, coating technique, and antiproliferative agent and dose may differ across the commercially available DCBs.
CONCLUSIONS: More data on the safety and efficacy of DCBs for BTK revascularization is needed with standardized study designs. Improvements of DCB technology to address complications of BTK revascularization might involve systematic modification of independent variables in DCB design, application of nanotechnology, characterization of the lesion with new imaging modalities, and/or determination of the need for specific directed therapy.
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