Fatih KAHRAMAN, Mehmet KILINÇ, Ömer GÖKTEKİN
Interventional Cardiology Perspectives - 2026;2(1):3-8
Background: Drug-coated balloons (DCBs) are now an established therapeutic option for the treatment of in-stent restenosis (ISR) and small-vessel coronary artery disease. They enable effective local delivery of antiproliferative agents without leaving a permanent metallic scaffold. Nevertheless, real-world evidence regarding the performance of DCBs in broader and more complex coronary lesion subsets remains limited. Aim: The [DCB in different clinical scenarios (DCS)] study (ClinicalTrials.gov identifier: NCT06915597) is designed to evaluate procedural strategies, safety, and clinical outcomes associated with DCB use across a wide range of coronary lesion types in routine clinical practice. Study Design: This is a multicenter, observational, prospective and retrospective study. Methods: The DCB-DCS study is a national, multicenter, observational registry that integrates both prospective and retrospective cohorts from 17 centers across Türkiye. Consecutive patients undergoing DCB angioplasty for de novo lesions, ISR, small-vessel disease, bifurcation lesions, or chronic total occlusions will be enrolled. The selection of the DCB device, lesion preparation strategy, and use of intravascular imaging will be left entirely to the operator's discretion. All procedures will be performed in accordance with contemporary DCB recommendations. Routine angiographic follow-up will not be mandated. The primary endpoint is procedural success. Secondary endpoints include target lesion revascularization, target vessel revascularization, acute vessel occlusion, all-cause mortality, and bleeding events. Results: Data collection is currently ongoing. Baseline demographic and clinical characteristics, procedural details, and clinical outcomes will be analyzed after completion of patient enrollment and follow-up. Conclusion: As the largest and most comprehensive DCB registry conducted in Türkiye, the DCB-DCS study will provide real-world evidence on the expanding application of DCBs across diverse coronary scenarios. The findings are expected to identify optimal procedural approaches and inform the design of future randomized controlled trials comparing DCBs with contemporary-generation stent technologies.
