Coronary disease & ACSSecondary analysis
Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis
- Secondary analysis of the AGENT IDE randomised trial
- prospective
- multicentre
- 2:1 allocation
- stratified by multi- vs single-layer in-stent restenosis (ISR) and centre
Authors' conclusion
Patients with ISR of multiple stent layers had higher rates of adverse stent-related events compared with patients with single-layer ISR. Treatment with a paclitaxel-coated balloon led to greater absolute risk reduction in 1-year TLF among patients with multilayer ISR compared with an uncoated balloon.
Study context
- Population
- Patients with coronary ISR (reference vessel diameter >2.0 mm to ≤4.0 mm, lesion length <26 mm), multilayer or single-layer258 (44%) multilayer ISR
- Participants
- 600 patients
- Comparison
- Paclitaxel-coated balloon vs uncoated balloon, by multilayer vs single-layer ISR
- Primary endpoint
- Target lesion failure (TLF): ischaemia-driven target lesion revascularization (TLR), target vessel-related myocardial infarction (MI) or cardiac death
- Follow-up
- 1 year
Primary result
As reported in the abstract
1-year TLF by ISR layer (subgroups)
Paclitaxel-coated vs UncoatedHazard ratio (95% CI)P value
multilayer ISR: 23.8% vs 40.0%
0.55(0.34–0.87)
P = 0.01single-layer ISR: 13.5% vs 20.2%
0.64(0.37–1.11)
P = 0.11Further findings
| Outcome | P value |
|---|---|
| 1-year TLF, multilayer vs single-layer ISR · 29.0% vs 15.7% | P < 0.0001 |
Original publication
Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis. J Am Coll Cardiol. Published 19 August 2025. doi:10.1016/j.jacc.2025.05.062
Summarised from the published abstract; every number is checked against it