What is the role of drug-coated balloons (DCB) in treating de novo lesions?

Drug-Coated Balloons for De Novo Coronary Lesions

Drug-coated balloons are NOT recommended for routine treatment of de novo coronary lesions based on current guideline evidence, as the PEPCAD III trial demonstrated inferiority to drug-eluting stents in this setting. 1

Guideline-Based Recommendations

Primary Indication: In-Stent Restenosis Only

• The European Society of Cardiology recommends drug-eluting balloons (Class IIa, Level B) specifically for treatment of in-stent restenosis after prior bare metal stent implantation, NOT for de novo lesions. 1, 2

• The randomized PEPCAD III study definitively showed that combining a drug-eluting balloon with cobalt chromium stent implantation was inferior to sirolimus-eluting stents for de novo indications. 1

Why DCBs Fail in De Novo Lesions (Guideline Evidence)

• Drug-eluting balloons rely on short contact time between balloon and vessel wall for drug delivery, which works well in the contained environment of in-stent restenosis but lacks the structural support needed for de novo atherosclerotic lesions. 1

• Without a stent scaffold, elastic recoil and dissection in de novo lesions lead to suboptimal acute results and higher rates of target lesion revascularization. 1

Emerging Research Context (Not Guideline-Supported)

While recent observational studies suggest potential benefits in highly selected scenarios, these contradict established guideline evidence:

• A 2023 retrospective study showed lower target lesion failure with DCB-based treatment on the left anterior descending artery compared to drug-eluting stents, but this was non-randomized data with significant selection bias. 3

• The 2023 NOBITRE registry found that type C lesions treated with DCB had significantly higher MACE rates (adjusted OR 1.83), indicating poor outcomes in complex de novo anatomy. 4

• An Asia-Pacific consensus suggested DCB use for small vessels, bifurcations, and fractional flow reserve-guided larger vessels, but these are expert opinions without guideline endorsement. 5

Clinical Algorithm for Decision-Making

For any de novo coronary lesion requiring revascularization:

1. Default to drug-eluting stents as the guideline-recommended first-line therapy 2, 6

2. Consider DCB ONLY if:

   • Patient cannot tolerate 12 months of dual antiplatelet therapy (use bare metal stent instead, not DCB) 6
   • Treating in-stent restenosis (the only Class IIa indication) 1, 2

3. Avoid DCB in de novo lesions with:

   • Type C lesion characteristics (high MACE risk, adjusted OR 1.83) 4
   • Need for optimal acute angiographic result
   • Standard anatomical features where drug-eluting stents have proven superiority 1

Critical Pitfalls to Avoid

• Do not extrapolate DCB success in in-stent restenosis to de novo lesions – the pathophysiology and vessel response are fundamentally different. 1

• Do not assume a "leave nothing behind" strategy is superior – the PEPCAD III trial proved otherwise for de novo lesions. 1

• Do not rely on observational registry data when randomized controlled trial evidence (PEPCAD III) clearly demonstrates inferiority. 1

• Recognize that newer research suggesting DCB benefits in de novo lesions directly contradicts the only randomized trial evidence cited in European guidelines, which showed inferiority. 1, 3

Current Standard of Care

Drug-eluting stents remain the default choice for nearly all de novo coronary lesions to prevent restenosis, myocardial infarction, and acute stent thrombosis. 6 The American College of Cardiology and European Society of Cardiology both prioritize drug-eluting stents over alternative strategies for de novo disease. 2, 6

The only established role for DCB in coronary intervention is treating in-stent restenosis after bare metal stent implantation, where three randomized trials (PACCOCATH-I, PACCOCATH-II, and PEPCAD-II) demonstrated efficacy. 1, 2