Drug-Coated Balloons for De Novo Coronary Lesions

Guideline-Based Recommendations

• 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, 6
• The American College of Cardiology and European Society of Cardiology both prioritize drug-eluting stents over alternative strategies for de novo disease 6, 7
• Drug-eluting stents remain the default choice for nearly all de novo coronary lesions to prevent restenosis, myocardial infarction, and acute stent thrombosis 7

Clinical Evidence

• 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, 2, 3, 4, 5
• 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, 2
• 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, 2

Treatment Approach

• Default to drug-eluting stents as the guideline-recommended first-line therapy for de novo coronary lesions 6, 7
• Consider DCB ONLY if treating in-stent restenosis (the only Class IIa indication) 1, 2, 6