PREDICTORS OF TARGET LESION FAILURE IN PATIENTS WITH IN-STENT RESTENOSIS: INSIGHTS FROM THE AGENT IDE TRIAL

BACKGROUND: Predictors of target lesion failure (TLF) after percutaneous coronary intervention with drug-coated balloon therapy in patients with in-stent restenosis, as opposed to de novo disease, are limited. This post hoc analysis of the AGENT IDE trial (Agent Paclitaxel-Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) aimed to identify predictors of TLF in patients with in-stent restenosis treated with a paclitaxel-coated balloon. METHODS: Of the 600 patients with in-stent restenosis in the AGENT IDE trial, 406 were randomized to treatment with the paclitaxel-coated balloon. Among this cohort, demographic, clinical, and core laboratory angiographic data were assessed using a Cox proportional hazards model to identify independent predictors of TLF, defined as the composite occurrence of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death, at 2-year follow-up. RESULTS: Independent risk factors for 2-year TLF, which occurred in 106 (27.0%) of patients, included multiple stent layers (hazard ratio, 1.80 [95% CI, 1.23-2.65]), White race (hazard ratio, 1.71 [95% CI, 1.03-2.85]), and postlesion preparation in-lesion % diameter stenosis (per 10% increment; hazard ratio, 1.16 [95% CI, 1.03-1.31]). The presence of the target lesion in the left anterior descending artery was associated with a reduced risk of 2-year TLF (hazard ratio, 0.56 [95% CI, 0.36-0.87]). CONCLUSIONS: Our findings highlight the variable risk of in-stent restenosis governed by relatively few patient and lesion factors and underscore the significance of optimal lesion preparation before drug-coated balloon therapy as a potentially modifiable factor. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04647253.