Key result
Paclitaxel-coated balloon angioplasty yields a ~14% 12-month MACE rate in coronary disease.
Why the study?
What is the 12-month rate of major adverse cardiac events following percutaneous coronary intervention with a paclitaxel-coated balloon in ethnically Chinese patients with in-stent restenosis or de novo coronary artery disease?
Cohort (n=500)
Open-label
Yes
What is the 12-month rate of major adverse cardiac events following percutaneous coronary intervention with a paclitaxel-coated balloon in ethnically Chinese patients with in-stent restenosis or de novo coronary artery disease?
Answers are grounded in this paper and cite their sources.
This prospective registry demonstrates that the AGENT paclitaxel-coated balloon is safe and effective in real-world ethnically Chinese patients with ISR or de novo coronary disease, while showing that routine surveillance angiography substantially increases repeat revascularization rates (26.9% vs 4.9% MACE).
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).
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Lu et al. (2026) conducted a cohort in In-stent restenosis (ISR) or de novo coronary artery disease (n=500). Paclitaxel-coated balloon (AGENT) percutaneous coronary intervention was evaluated on 12-month major adverse cardiac events (MACEs; composite of cardiac death, any myocardial infarction, or target vessel revascularization) (95% CI 11.0%-17.3%). Paclitaxel-coated balloon angioplasty resulted in a 12-month major adverse cardiac event rate of 13.9% (95% CI 11.0%-17.3%) in Chinese patients with in-stent restenosis or de novo coronary disease.
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