Drug-coated Balloons Versus Drug-eluting Stents for de Novo Small-vessel Coronary Artery Disease

Overview

This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels. The treatment strategy will be selected by the treating interventional cardiologist according to the patient's clinical and angiographic characteristics and will not be assigned randomly by the study. Participants will receive standard clinical care and will be followed for 12 months. The study will evaluate major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and the need for repeat treatment of the target lesion. Procedural outcomes and treatment-related complications will also be recorded.

Small-vessel coronary artery disease remains a challenging setting for percutaneous coronary intervention because the limited vessel diameter increases the potential clinical impact of neointimal proliferation and restenosis. Second-generation drug-eluting stents represent an established treatment strategy, whereas drug-coated balloons deliver an antiproliferative agent without leaving a permanent metallic scaffold. This is a prospective, multicenter, non-randomized observational study of consecutive patients undergoing percutaneous coronary intervention for de novo small-vessel coronary lesions. Lesion preparation and all procedural decisions will be performed according to contemporary clinical practice. Following adequate lesion preparation, the selection of a drug-coated balloon or a second-generation drug-eluting stent will be made by the treating interventional cardiologist on the basis of clinical, angiographic, and procedural considerations. The study protocol does not assign treatment and does not alter routine patient care. Baseline demographic and clinical characteristics, angiographic findings, lesion characteristics, procedural details, device-related information, and in-hospital events will be recorded prospectively. Participants will undergo clinical follow-up for 12 months to document cardiovascular events, repeat coronary revascularization, and other relevant clinical outcomes. Outcomes will be compared between the drug-coated balloon and drug-eluting stent cohorts, taking into consideration the non-randomized nature of treatment selection and potential baseline differences between the groups.