The Present and Future
JACC State-of-the-Art Review
Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review

https://doi.org/10.1016/j.jacc.2019.12.046Get rights and content
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Highlights

  • DCB shows mixed results in treating de novo coronary artery disease.

  • Procedural approach and technology variations account for differences in results.

  • “Leave nothing behind” strategy has shown better outcomes than combined therapy.

  • Future well-designed clinical trials with strict inclusion criteria are needed.

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.

Key Words

coronary artery disease
drug-coated balloon
drug-eluting balloon
paclitaxel-coated balloon
paclitaxel-eluting balloon
small-vessel disease

Abbreviations and Acronyms

BMS
bare-metal stent(s)
DCB
drug-coated balloon(s)
DES
drug-eluting stent(s)
ISR
in-stent restenosis
LLL
late lumen loss
MACE
major adverse cardiovascular event(s)
POBA
plain old balloon angioplasty
STEMI
ST-segment elevation myocardial infarction
TLR
target lesion revascularization

Cited by (0)

Dr. Weintraub has received consulting honoraria and grants from Amarin; has served on the Advisory Board of AstraZeneca; and has been a consultant for scPharmaceuticals. Dr. Waksman has served on the Advisory Boards of Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, and Pi-Cardia Ltd.; has been a consultant for Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, and Pi-Cardia Ltd.; has received grant support from AstraZeneca, Biotronik, Boston Scientific, and Chiesi; has served on the Speakers Bureaus of AstraZeneca and Chiesi; and has investments in MedAlliance. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.