Intravascular Ultrasound Predictors of 12-month Patency Loss Following Drug-Coated Balloon Angioplasty for the Femoropopliteal Artery.

Abstract

Intravascular ultrasound (IVUS) has been shown to improve outcomes of drug-coated balloon (DCB) angioplasty for treatment of femoropopliteal artery (FPA) disease. However, the optimal IVUS criteria for achieving improved outcomes of DCB angioplasty for FPA disease remain uncertain. The study aimed to identify IVUS predictors for loss of patency at 12 months after DCB angioplasty for FPA disease. After excluding one patient due to insufficient IVUS imaging data, 98 patients in the IVUS-guidance group of the IVUS-DCB trial were included in the analysis. IVUS parameters predicting loss of patency at 12 months and their optimal cut-off values were investigated. Among the 98 patients who underwent IVUS-guided FPA intervention, 16 patients (16.3%) lost primary patency within 12 months. End-stage renal disease on hemodialysis and, bailout stenting, post-procedural dissection length >50% were independent procedural predictors for 12-month patency loss. Receiver operating characteristic (ROC) curve demonstrated that post-procedural minimal lumen area (MLA) ≥11.6 mm² (area under the ROC curve: 0.685, 95% CI: 0.513-0.857) as the optimal cut-off value for sustained primary patency. In survival analysis, patients with MLA ≥11.6 mm² had a hazard ratio of 0.27 (95% CI: 0.09-0.80, p-value =0.019, risk difference: 19.8) for lower risk of patency loss. A post-procedural MLA ≥11.6 mm² was an independent IVUS predictor for sustained primary patency after DCB angioplasty in patients with FPA disease. Our findings suggest that lesion optimization and achieving sufficient lumen area under IVUS guidance during DCB angioplasty are crucial for maintaining target vessel patency. TRIAL REGISTRATION: ClinicalTrial.gov, identifier NCT03517904.