Drug-Coated Balloons for In-Stent Restenosis and De Novo Coronary Lesions: State of the Art and Lessons Learned From Recent Trials

Drug-coated balloons (DCB) have emerged as an important treatment modality in percutaneous coronary intervention by providing effective local antiproliferative drug delivery without leaving a permanent metallic implant. Robust evidence supports their use for the treatment of coronary in-stent restenosis (ISR), where DCB represent an established alternative to repeat drug-eluting stent (DES) implantation while avoiding additional stent layers. Contemporary data suggest that although repeat DES implantation may reduce TLR in selected patients with DES-ISR, DCB remain particularly attractive in many patient subsets, including those with excellent predilation results, multiple stent layers, major side branches, and those with bare-metal ISR. Careful lesion preparation and increasing use of intracoronary imaging are critical determinants of procedural success. Beyond ISR, evidence supporting DCB in de novo coronary disease has expanded substantially, particularly in small-vessel disease, where randomized trials and patient-level meta-analyses demonstrate outcomes comparable or superior to contemporary DES. Growing data also support DCB use in selected complex anatomical and clinical scenarios, including bifurcation lesions, diabetes, acute coronary syndromes, and patients at high bleeding risk. Recent randomized trials evaluating DCB in broader all-comer populations have yielded mixed results, highlighting the absence of a class effect among DCB technologies and the importance of device choice, operator experience, and optimal patient selection. Ongoing randomized trials evaluating next-generation paclitaxel- and limus-based DCB are expected to better define patient selection and the complementary roles of DCB and DES. Rather than competing technologies, DCB and DES should be considered complementary tools that enable increasingly personalized coronary revascularization strategies.