Turk Kardiyol Dern Ars. Ahead of Print: TKDA-46443 | DOI: 10.5543/tkda.2026.46443
Clinical Outcomes Through 12 Months After Drug-Coated Balloon-Based Coronary Intervention: A Single-Center Real-World Registry
Hasan Burak İşleyen1, Sezgin Uzunoğlan2, Behice Hande Şişman2, Oğuzhan Abanoz3, Esra Danışman3, Mahmut Uluganyan31Department of Cardiology, Nişantaşı University, Faculty of Medicine, İstanbul, Türkiye; Department of Cardiology, Bezmialem Foundation University, Faculty of Medicine, İstanbul, Türkiye
2Department of Cardiology, Kırklareli Training and Research Hospital, Kırklareli, Türkiye
3Department of Cardiology, Bezmialem Foundation University, Faculty of Medicine, İstanbul, Türkiye
Objective: Real-world registries complement clinical trial evidence by characterizing outcomes of drug-coated balloon (DCB) interventions across heterogeneous coronary lesions. This study described clinical outcomes through 12 months and the completeness of follow-up in a single-center registry.
Method: Patients who underwent DCB-based coronary intervention at a single tertiary referral center between September 2023 and November 2025 were retrospectively reviewed. The eligible cohort comprised 352 patients and 414 index-procedure lesions; time-to-event analyses included 288 patients with a recorded follow-up interval greater than zero. The primary reported outcome was a post hoc, non-prespecified composite of all-cause death, any myocardial infarction, or target lesion revascularization (TLR). Only events with a valid post-index date were included. Kaplan-Meier estimates were truncated at 365 days.
Results: The median follow-up duration was 202.5 days (interquartile range, 83.5–340.0); 158 (54.9%) and 60 (20.8%) patients had at least 180 and 365 days of recorded follow-up, respectively. During all available follow-up, the study-defined composite occurred in 22/288 patients (7.6%), and TLR occurred in 17/288 (5.9%). The 12-month Kaplan-Meier estimate was 10.5% (95% CI, 6.2%–17.3%; 55 at risk) for the composite and 8.5% (95% CI, 4.6%–15.4%; 56 at risk) for TLR. Exploratory inverse-probability-of-observation-weighted estimates were similar.
Conclusion: In this heterogeneous single-center registry, the 12-month estimates were 10.5% for the composite and 8.5% for TLR, with similar exploratory weighted results. These findings provide contemporary descriptive single-center registry data following DCB-based intervention; however, interpretation should remain cautious because only 20.8% of patients had at least 365 days of recorded follow-up, and only 55–56 patients remained at risk at day 365.
Keywords: Coronary artery disease, drug-coated balloon, percutaneous coronary intervention, target lesion revascularization, treatment outcome.
Corresponding Author: Hasan Burak İşleyen
Manuscript Language: English