Leave nothing behind: Promising results for coronary drug-coated balloons in clinical practice
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Updated: Jan 29, 2026

The Intra-Aortic Balloon Pump
Published on: February 5, 2021
Bimmer E Claessen1, George D Dangas1
1Department of Cardiology, Mount Sinai Hospital, New York, New York.
Insights
Paclitaxel drug-coated balloons show promising short-term results for coronary artery disease and in-stent restenosis. Further randomized trials are needed to confirm long-term safety and efficacy.
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Biomaterials Science
Background:
- A multinational registry evaluated paclitaxel drug-coated balloons in 1,025 patients with de novo coronary artery disease or in-stent restenosis (ISR).
- The study assessed the safety and efficacy of drug-coated balloons, noting a low bail-out stenting rate of 4.8%.
Discussion:
- Short-term outcomes indicate favorable results for drug-coated balloon treatment in both de novo lesions and ISR.
- One-year target lesion revascularization rates were low: 2.3% for de novo lesions, 2.9% for bare metal stent ISR, and 5.8% for drug-eluting stent ISR.
Key Insights:
- Paclitaxel drug-coated balloons demonstrate promising short-term efficacy in treating coronary artery disease and ISR.
- Low bail-out stenting and low target lesion revascularization rates suggest good procedural success and clinical outcomes.
Outlook:
- Long-term safety and efficacy data are crucial for establishing the definitive role of drug-coated balloons.
- Randomized controlled trials are recommended to provide higher-level evidence and confirm these promising findings.
Abstract:
1,025 patients with de novo coronary artery disease (66.9%) or in-stent restenosis (ISR) (33.1%) underwent treatment with paclitaxel drug-coated balloons in a multinational single-arm registry. Bail-out stenting rate was only 4.8%. One-year target lesion revascularization was 2.3% for de novo lesions, 2.9% for bare metal stent ISR, and 5.8% for drug-eluting stent ISR. Short-term results with coronary drug-coated balloons are promising. Nonetheless, long-term data, preferably from randomized trials are necessary to confirm their safety and efficacy.
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