Drug-Coated Balloons for Proximal Coronary Lesions
Drug-coated balloons should NOT be used for de novo proximal coronary lesions; drug-eluting stents remain the guideline-endorsed first-line therapy for this indication. 1, 2
Guideline Position on DCB for De Novo Disease
The major cardiovascular societies have explicitly rejected DCBs for de novo coronary lesions, including proximal vessels:
The European Society of Cardiology provides Class I, Level A recommendation for DCBs specifically for in-stent restenosis only, and explicitly does NOT recommend DCBs for de novo coronary lesions. 1
Both the American College of Cardiology and European Society of Cardiology prioritize drug-eluting stents over alternative strategies for de novo disease. 2, 3
The ESC recommends drug-eluting balloons as Class IIa, Level B specifically for treatment of in-stent restenosis after prior bare metal stent implantation, NOT for de novo lesions. 2
Why DCBs Fail in De Novo Proximal Lesions
The fundamental problem is mechanical, not pharmacologic:
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. 4, 2
Without a stent scaffold to prevent elastic recoil, DCBs and plain balloon angioplasty have inferior acute results in de novo lesions compared to stenting. 1
DCBs work well in the contained environment of in-stent restenosis where the existing stent scaffold prevents elastic recoil, but lack the structural support needed for de novo atherosclerotic lesions. 2
Elastic recoil and dissection in de novo lesions lead to suboptimal acute results and higher rates of target lesion revascularization when DCBs are used without stenting. 2
The Correct Treatment Algorithm for Proximal Coronary Lesions
For any de novo proximal coronary lesion (LAD, LCx, or RCA):
Default to drug-eluting stents as the guideline-recommended first-line therapy. 2
Consider DCB ONLY if treating in-stent restenosis within a previously placed stent in that proximal vessel (the only Class IIa indication). 2, 3
If the patient has ISR in a proximal vessel and anatomic factors are appropriate, it is reasonable to perform repeat PCI with either a DES or DCB. 3
Common Pitfall to Avoid
Do not be swayed by recent research enthusiasm for DCBs in various coronary scenarios. 5, 6, 7, 8 While investigational interest is growing and trials are ongoing, the current guideline-based standard of care for de novo proximal coronary lesions remains drug-eluting stents. 1, 2 The mechanism of DCB drug delivery—relying on short contact time between balloon and vessel wall—works for in-stent restenosis but fails in de novo disease where no scaffold exists to maintain luminal patency. 2