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Progress on developing an effective below-the-knee drug-coated balloon
Rym El Khoury1, Marianne Brodmann2, Peter A Schneider1
1Division of Vascular and Endovascular Surgery, University of California, San Francisco, CA 94143, USA.
Insights
Drug-coated balloons (DCBs) face challenges in treating infrapopliteal atherosclerotic disease due to restenosis and recoil. This review explores DCB evolution, clinical results, and future technologies for below-the-knee lesions.
Area of Science:
- Vascular medicine and interventional cardiology
- Biomaterials and drug delivery systems
Background:
- Infrapopliteal atherosclerotic disease presents significant challenges for endovascular treatment.
- Conventional angioplasty often results in early restenosis and recoil in complex, calcified, below-the-knee lesions.
- Drug-eluting stents successful in coronary arteries have shown limited efficacy in tibial arteries.
Purpose of the Study:
- To review the evolution and challenges of drug-coated balloon (DCB) technology for infrapopliteal arteries.
- To present clinical outcomes of currently available tibial DCBs.
- To introduce emerging advancements in DCB technology.
Main Methods:
- Review of existing literature on infrapopliteal angioplasty and DCB technology.
- Analysis of clinical trial data for paclitaxel-coated balloons and other DCBs.
- Discussion of the scientific basis and future directions of DCB development.
Main Results:
- Conventional angioplasty has limitations in treating complex infrapopliteal lesions.
- Initial promise of paclitaxel-coated balloons has not been consistently met in large trials.
- Controversy exists regarding paclitaxel-associated mortality.
Conclusions:
- Drug-coated balloons represent an evolving therapeutic option for infrapopliteal atherosclerotic disease.
- Further research and technological innovation are needed to overcome current limitations.
- New horizons in DCB technology may offer improved outcomes for below-the-knee interventions.
Abstract:
Infrapopliteal atherosclerotic disease continues to present the greatest conundrum for effective endovascular therapies. To date, conventional angioplasty has been fraught with early restenosis and recoil in these complex, long, calcified, and occlusive lesions. The success of metallic drug-eluting stents in coronary arteries has not carried over to below-the-knee arteries. Initial promise in paclitaxel-coated balloons has not been demonstrated in large randomized clinical trials. Furthermore, the potential association between paclitaxel and mortality continues to generate tremendous controversy. The goal of this review article is to discuss the evolution and challenges of drug-coated balloon (DCB) science, present the clinical results of currently available tibial DCBs, and introduce new horizons in DCB technology.
