Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis: AGENT IDE Subgroup Analysis

Area of Science:

• Cardiovascular Interventions
• Interventional Cardiology
• Medical Device Technology

Background:

• Coronary in-stent restenosis (ISR) involving multiple stent layers presents a significant clinical challenge.
• Higher rates of restenosis and the avoidance of additional stent layers are key concerns in multilayer ISR.
• Drug-coated balloons (DCBs) offer a non-stenting antiproliferative treatment option for multilayer ISR.

Purpose of the Study:

• To evaluate the efficacy and safety of paclitaxel-coated balloons versus uncoated balloons in patients with multilayer or single-layer ISR.
• The AGENT IDE trial assessed outcomes in patients undergoing treatment for in-stent restenosis.

Main Methods:

• A prospective, multicenter trial randomized 600 patients with ISR (reference vessel diameter >2.0 mm to ≤4.0 mm, lesion length <26 mm) in a 2:1 ratio to paclitaxel-coated or uncoated balloons.
• Randomization was stratified by multilayer versus single-layer ISR and by study center.
• The primary endpoint was 1-year target lesion failure (TLF), a composite of ischemia-driven target lesion revascularization (TLR), target vessel-related myocardial infarction (MI), or cardiac death.

Main Results:

• Multilayer ISR (44% of patients) was associated with significantly higher 1-year TLF rates (29.0%) compared to single-layer ISR (15.7%).
• In patients with multilayer ISR, paclitaxel-coated balloons showed a significant reduction in TLF (23.8%) versus uncoated balloons (40.0%, P=0.01), driven by lower TLR and MI rates.
• Similar, though not statistically significant, trends were observed in single-layer ISR patients, with lower TLF for paclitaxel-coated balloons (13.5%) versus uncoated balloons (20.2%).

Conclusions:

• Patients with multilayer ISR experience higher adverse stent-related event rates compared to those with single-layer ISR.
• Paclitaxel-coated balloons demonstrated a greater absolute risk reduction in 1-year TLF for multilayer ISR patients compared to uncoated balloons.
• The AGENT IDE trial supports the use of paclitaxel-coated balloons for treating complex in-stent restenosis, particularly in multilayer cases.