The Utility of Intravascular Ultrasound Evaluation in Addition to the Conventional Risk Factors for Predicting Restenosis After Endovascular Therapy Using Drug-Coated Balloon in Femoropopliteal Artery Lesions

Abstract

Purpose:

Baseline lesion characteristics have been reported to be associated with vessel patency after drug-coated balloon (DCB) treatment for femoropopliteal artery lesions. Intravascular ultrasound (IVUS) evaluation was also associated with vessel patency. The present study aimed to investigate whether the IVUS endpoints could predict the incidence of restenosis after DCB treatment, independent of classical risk factors.

Methods:

We retrospectively reviewed 111 patients with 147 consecutive femoropopliteal (FP) lesions treated with IVUS-guided endovascular therapy (EVT) using DCB between 2021 and 2023. We assessed the association between 1-year restenosis and sufficient postprocedural lumen area measured by IVUS, in addition to the classical risk score, including no below-the-knee runoff, a history of EVT, distal reference vessel diameter of <5 mm, Peripheral Arterial Calcium Scoring System grade 4, chronic total occlusion (CTO), popliteal segments, low-dose DCB, and residual stenosis. The sufficient lumen area was defined as that ≥12.7 mm².

Results:

The chronic limb-threatening ischemia, CTO, and hemodialysis rates were 23%, 48%, and 16%, respectively. Restenosis was found in 38 lesions (26%) at 1 year. The Cox multivariate analysis showed that the classical risk score was an independent predictor of restenosis (hazard ratio [HR] = 1.45, per 1.0, P = .018), whereas sufficient lumen area was protective against restenosis (HR = 0.40, P = .015).

Conclusion:

The IVUS evaluation might be associated with restenosis onset after DCB treatment, independent of the classical risk factors.

Clinical Impact

In femoropopliteal endovascular therapy, we demonstrate that intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) is an independent predictor of restenosis beyond the established predictors of patency after coated balloon angioplasty (POPCORN) risk factors. Incorporating MLA into periprocedural assessment may help with risk stratification, device selection, and planning of postprocedural surveillance.