Clinical Research Directory

OPtimization of Antiplatelet Therapy After the intervenTION of de Novo Coronary Artery Lesions With Drug-Coated Balloons

Sponsor: Shanghai Zhongshan Hospital

Summary

Coronary atherosclerotic disease remains one of the leading causes of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) and drug-eluting stents (DES) implantation has significantly improved clinical outcomes, long-term studies have demonstrated that stent-related complications-including late restenosis, very late thrombosis, impaired vascular compliance due to permanent metal residue, and bleeding risk associated with prolonged dual antiplatelet therapy (DAPT)-have yet to be fundamentally resolved. Drug-coated balloon (DCB) has emerged as a "metal-free" alternative strategy, delivering antiproliferative drugs to the vessel wall during balloon expansion, with the aim of reducing metal residue, promoting vascular healing, and lowering the incidence of long-term adverse events. Multiple high-quality studies have validated the safety and efficacy of DCB in the setting of in-stent restenosis (ISR) and small-vessel de novo lesions. The international DCB consensus has explicitly incorporated ISR and small-vessel disease into the category of established indications. Recent studies have demonstrated that, in small-vessel lesions, DCB is comparable to second-generation DES with respect to target lesion revascularization (TLR) and major adverse cardiovascular events (MACE), while conferring a lower risk of long-term stent-related complications. These advances have prompted relevant expert panels to publish operational standards and indication guidelines for DCB. Meanwhile, the research focus of DCB is gradually expanding toward "large-vessel de novo lesions." This lesion subset is typically characterized by a reference vessel diameter ≥2.75-3.0 mm, high lesion burden, and impaired vascular compliance. Several international studies have found that, under conditions of adequate lesion preparation-defined as residual stenosis \<30%, absence of severe dissection, and sufficient lesion expansion-DCB treatment of large-vessel de novo lesions can yield satisfactory outcomes. China has rapidly followed suit, with experts revising the national expert consensus in 2024 to refine the application of drug-coated balloons in coronary stenotic lesions. Owing to the absence of permanent metallic stent residue and the short duration of local drug action, DCB theoretically permits the use of a less intensive antiplatelet regimen. However, clinical trial evidence regarding the optimal antiplatelet strategy following DCB treatment remains lacking. This study aims to investigate whether, among patients with chronic coronary syndrome (CCS) undergoing DCB treatment, 1 month of dual antiplatelet therapy post-procedure is non-inferior to 6 months of dual antiplatelet therapy with respect to target vessel failure (TVF) at 1 year.

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