Primary Outcomes of Paclitaxel-Coated Balloon Use in Long In-Stent Restenosis Lesions: Results from the Nonrandomized Cohort of the AGENT IDE Trial

Document Type

Conference Proceeding

Publication Date

3-9-2026

Publication Title

JACC Cardiovasc Interv

Keywords

Cardiovascular System & Cardiology

Abstract

BACKGROUND: Longer lesions treated with drug-eluting stents are associated with increased adverse events and repeat revascularization. Drug-coated balloons (DCBs) are a potential option for patients with diffuse in-stent restenosis (ISR), but clinical evidence supporting DCBs in long coronary ISR is limited. The AGENT IDE trial demonstrated superior efficacy of a paclitaxel-coated balloon compared to conventional balloon angioplasty (BA) for treating ISR. The trial also included a non-randomized cohort with longer coronary ISR lesions (ClinicalTrials.gov #NCT06492174). METHODS: This is a prospective, multicenter, non-randomized, single-arm cohort of the AGENT IDE trial assessing AGENT DCB in patients with long ISR lesions. Patients with ISR in a native coronary artery previously treated with a DES or bare metal stent with reference vessel diameter [RVD]>2.0 to ≤ 4.0 mm and target lesion ≥ 26 mm and ≤ 36 mm in length were enrolled, after successful lesion preparation. Key clinical exclusion criteria included recent ST-elevation or Q-wave myocardial infarction (MI), chronic kidney disease (creatinine ≥ 2.0 mg/dl or dialysis) and left ventricular ejection fraction <25%. Angiographic exclusion included unprotected left main stenosis (>50% diameter stenosis), target lesion in a saphenous vein or arterial graft, and thrombus in the target vessel. The target lesion was treated with one 40 mm AGENT DCB. The primary endpoint was 1-year target lesion failure (TLF: a composite occurrence of ischemia-driven target lesion revascularization [TLR], target vessel related MI, or cardiac death). An independent Clinical Events Committee adjudicated major adverse events. RESULTS: A total of 20 patients were enrolled at 12 US sites. Mean age was 68 years, 25% of enrolled patients were women, and 26% patients had diabetes. Single layer ISR was treated in 45% of patients and multiple layer ISR in 55%. Angiographic core lab–reported mean RVD and lesion length was 2.65 mm and 25.0 mm, respectively. Clinical outcomes (including overall TLF and individual components, and prespecified endpoints) through 1-year are currently undergoing adjudication. CONCLUSION: Data from the long lesion cohort of the AGENT IDE trial will provide clinical evidence regarding the safety and efficacy of the AGENT DCB for the management of this challenging patient population. Primary endpoint results will be presented for the first time at CRT 2026.

Volume

19

Issue

5

First Page

S17

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