Yonsei Med J.  2023 Oct;64(10):593-603. 10.3349/ymj.2022.0606.

Drug-Coated Balloons for De Novo Coronary Artery Lesions: A Meta-Analysis of Randomized Clinical Trials

• Wang D
• Wang X
• Yang T
• Tian H
• Su Y
• Wang Q

• KMID: 2546246
• DOI: http://doi.org/10.3349/ymj.2022.0606

Abstract

Purpose
Through meta-analysis, we aimed to assess the efficacy and safety of drug-coated balloons (DCB), compared with drugeluting stents (DES) or uncoated devices, in the treatment of de novo coronary lesions.
Materials and Methods
Only randomized controlled trials were included. The primary outcomes were late lumen loss (LLL), target lesion revascularization (TLR), and major adverse cardiac events (MACEs). Subgroup analyses were conducted based on clinical indications, whether DCBs were used with a systematic or bailout stent, and types of DESs.
Results
The present meta-analysis demonstrated that DCBs elicit significantly lower incidences of TLR, MACE, and LLL, compared with uncoated devices, and similar incidences, compared with DESs, in the treatment of de novo coronary lesions. Subgroup analysis indicated that DCBs used with a bailout stent achieved lower incidences of binary restenosis and myocardial infarction, compared with uncoated devices, and provided less LLL than DESs. DCBs showed similar rates of TLR and MACE, with significantly less LLL, than DESs in treating de novo small-vessel diseases. The clinical efficacy of DCBs was similar to that of secondgeneration DES.
Conclusion
Overall, DCB is favored over bare metal stent alone in treating de novo coronary lesions. DCBs appear to be a promising alternative to DESs in the treatment of de novo coronary lesions.

Keyword

Coronary artery disease; drug-coated balloon; drug-eluting stents; bare metal stent; de novo lesions; small-vessel disease