Physiologic Assessment Using Angiography‐Derived Fractional Flow Reserve After Drug‐Coated Balloon Angioplasty in De Novo Coronary Lesions

BACKGORUND: Drug-coated balloon (DCB) angioplasty offers a potential alternative to avoid permanent metallic stent implantation and the associated risk of in-stent restenosis. AIMS: This study aimed to evaluate the safety and effectiveness of DCB angioplasty for de novo coronary stenoses in real-world clinical practice. METHODS: This was a single-center, retrospective observational study. Between March 2017 and October 2023, patients who underwent DCB angioplasty for at least one de novo coronary stenosis were included. The primary endpoint was the device-oriented composite endpoint (DOCE), defined as a composite of cardiovascular death, device failure-related myocardial infarction, or device failure-related target lesion revascularization. Post-procedural angiography-derived fractional flow reserve (vFFR) was evaluated after DCB angioplasty in eligible patients with angiograms of adequate quality. RESULTS: A total of 255 de novo coronary stenoses undergoing DCB angioplasty were analyzed. Among the treated lesions, 92.5% were located in the main epicardial vessels. Cutting or scoring balloons and rotational atherectomy were employed for lesion preparation in 14.5% and 5.9% of lesions, respectively. The bailout stenting rate was 1.9%. During a follow-up duration of 558 ± 499 days, the primary endpoint, DOCE, occurred in 13 lesions (5.1%). Post-procedural vFFR was analyzable in 130 lesions. Residual stenosis ≤ 30% was achieved in only 39.1% of lesions, whereas 80.7% of lesions demonstrated a post-procedural vFFR ≥ 0.75. CONCLUSIONS: Patients undergoing DCB angioplasty for de novo coronary stenoses demonstrated favorable clinical outcomes during mid-term follow-up. The clinical utility of vFFR in the context of DCB angioplasty warrants further investigation in large-scale studies to determine its impact on clinical outcomes.