Abstract
In-stent restenosis (ISR) continues to be a significant challenge in percutaneous coronary intervention, making patient selection and lesion preparation critical for successful drug-coated balloon therapy.
We report the first-in-human use of the AGENT paclitaxel-coated balloon in the United States, guided by patient-specific 3-dimensional coronary reconstruction and computational simulations. This computational simulation-informed strategy identified stiff fibrotic ISR, guiding lesion preparation with excimer laser coronary atherectomy, and noncompliant and cutting balloon inflations before drug-coated balloon deployment. Recurrent ISR at 8 months was successfully treated using the same simulation-guided approach with optimized device sizing.
Patient-specific computational simulations that integrated individual anatomy, physiology, and biology provided guidance on lesion preparation and device selection, leading to favorable clinical outcomes.
This report presents the first computational simulation-guided drug-coated balloon treatment of ISR integrating patient-specific anatomy, physiology, and biology.
Computational simulations combined with intracoronary imaging can enhance preprocedural planning, device selection, and outcomes in coronary interventions.