Two-year outcomes of drug-coated balloon only strategy for de novo lesions in large coronary vessels

Abstract

Abstract Background Drug-coated balloons (DCB) are effective for the treatment of in-stent restenosis and de novo lesions in small coronary vessels (reference vessel diameter: RVD < 3.0 mm). Recently, several studies have reported acceptable results of DCB for de novo lesions in large coronary vessels (RVD ≧ 3.0 mm). However, previous studies were limited, we investigated the clinical outcomes of the DCB only strategy for de novo lesions in large coronary vessels. Methods We retrospectively analyzed 97 patients with 107 de novo lesions (RVD ≧ 3.0 mm) who underwent DCB only angioplasty from January 2016 to December 2021. We scheduled angiographic follow-up at 6 months after procedure and analyzed quantitative coronary angiography (QCA) data. Results The mean duration of follow-up was 737.8 ± 512.6 days. Patients who met the high bleeding risk (HBR) criteria was 56 (57.7%). Procedure success rate was 97.2% (3 lesions needed bailout drug eluting stent implantation) and acute coronary occlusion was not observed. The 2-year cumulative incidences of all-cause death was 7.1%, cardiac death was 1.6%. Target vessel revascularization was 9.2%, target lesion revascularization was 4.2%, respectively. Two patients had major bleeding events (BARC type 3 or 5) within 3 months after treatment and during the DAPT period. No major bleeding events were observed during the SAPT period. Conclusion The clinical outcomes of the DCB only strategy for de novo lesions in large coronary vessels were safe and acceptable. Especially in HBR patients, DCB only strategy could be an alternative treatment option.