Paclitaxel-Coated Balloon for Coronary In-Stent Restenosis and De Novo Disease in Chinese Patients

BACKGROUND: Drug-coated balloons provide antiproliferative therapy without permanent implants and may benefit lesion subsets where drug-eluting stent performance is suboptimal. OBJECTIVES: To evaluate safety and effectiveness of a paclitaxel-coated balloon in a real-world cohort of ethnically Chinese patients with in-stent restenosis (ISR) or de novo coronary artery disease. METHODS: This was a prospective, multicenter, single-arm registry across 9 sites in Taiwan, Hong Kong, and Singapore. Patients undergoing percutaneous coronary intervention with paclitaxel-coated balloon (AGENT, Boston Scientific Corp.) for ISR or de novo coronary artery disease were included. Primary endpoint was 12-month major adverse cardiac events (MACEs; cardiac death, myocardial infarction, or target vessel revascularization). Secondary endpoints included target lesion revascularization, target lesion thrombosis, and 9-month angiographic outcomes. Events adjudicated by independent clinical events committee; angiography analyzed by independent core laboratory. RESULTS: A total of 500 patients (mean age 65.6 ± 11.2) were enrolled. At 365 days (IQR: 354-379) after the index procedure, 13.9% (68 of 489) of patients experienced MACE. MACE rates were 16.3% (48 of 294) and 10.5% (20 of 191), in ISR and de novo patients, respectively. Cardiac death and myocardial infarction rates were 1.6% (8 of 489) and 2.0% (10 of 489), respectively; target vessel revascularization occurred in 11.7% (57 of 489). Angiographic follow-up was performed in 35% (175 of 500) of patients. The 12-month MACE was significantly higher in patients undergoing surveillance angiography compared to without (26.9% [47 of 175] vs 4.9% [15 of 305], P < 0.001), driven by increased target lesion revascularization. CONCLUSIONS: Paclitaxel-coated balloon was safe and effective in ethnically Chinese patients. Surveillance imaging significantly influenced revascularization rates, underscoring its impact on clinical decision-making. (An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients; NCT04085445).