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Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review
Charan Yerasi1, Brian C Case1, Brian J Forrestal1
1Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
Insights
Drug-coated balloons (DCB) offer a promising alternative to drug-eluting stents for coronary artery disease, particularly in small vessels. This review examines DCB effectiveness and proposes future trial designs.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-eluting stents are standard for coronary artery disease revascularization, but restenosis remains a challenge.
- Drug-coated balloons (DCB) provide local antiproliferative agent delivery without a metallic scaffold.
- DCB have shown efficacy in in-stent restenosis and selected de novo lesions.
Purpose of the Study:
- To review the evidence from randomized trials on drug-coated balloon use in coronary artery disease.
- To analyze factors contributing to variable clinical outcomes with DCB therapy.
- To propose a framework for future clinical trials investigating DCB technology.
Main Methods:
- Systematic review of randomized controlled trials comparing DCB with other revascularization strategies.
- Analysis of procedural variations, including "leave nothing behind" and "combination therapy" approaches.
- Evaluation of DCB performance based on vessel size and specific lesion characteristics.
Main Results:
- DCB demonstrate significant benefit in treating in-stent restenosis.
- Clinical outcomes in de novo coronary artery disease are mixed, with notable success in small vessels.
- Variability in results is linked to DCB technology, procedural techniques, and vessel diameter.
Conclusions:
- Drug-coated balloons represent a viable stent-free option for specific coronary artery disease indications.
- Optimizing procedural strategies and patient selection is crucial for maximizing DCB efficacy.
- Future trials should standardize protocols and focus on well-defined patient and lesion subsets.
Abstract:
Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain high. Non-stent-based local drug delivery by a drug-coated balloon (DCB) has been investigated, as it leaves no metallic mesh. A DCB consists of a semicompliant balloon coated with antiproliferative agents encapsulated in a polymer matrix, which is released into the wall after inflation and contact with the intima. DCB have demonstrated effectiveness in treating in-stent restenosis. Clinical studies using DCB in de novo coronary artery disease have shown mixed results, with a major benefit in small-vessel disease. Differences in study results are not only due to variations in DCB technology but also to disparity in procedural approach, "leave nothing behind" or "combination therapy," and vessel size. This review focuses on the available evidence from randomized trials and proposes a design for future clinical trials.
