Impact of Postoperative Lumen Gain on the Reduction of Restenosis Risk after Endovascular Treatment using Drug-coated Balloon for Femoropopliteal Lesions Assessed by Intravascular Ultrasound.

Abstract

This study aimed to reveal whether a larger postprocedural minimum lumen area (MLA) would reduce restenosis risk after endovascular therapy (EVT) using drug-coated balloons (DCBs) in femoropopliteal (FP) lesions. This retrospective, nonrandomized, single-arm, and multicenter registry analyzed patients with FP lesions undergoing intravascular ultrasound (IVUS)-guided EVT with DCB between 2017 and 2021. The primary outcome was restenosis 1 year after EVT. The association between IVUS-based MLA and restenosis risk was investigated using a generalized propensity score (GPS) method to address imbalance of baseline covariates. The dose-response function of IVUS-measured MLA for restenosis risk was developed using the GPS-adjusted Cox proportional hazards regression model. This study enrolled consecutive 489 patients with 595 lesions undergoing DCB treatment. The median MLA (interquartile range) was 13.20 (9.90-16.91) mm2. Kaplan-Meier estimates showed that freedom from restenosis was 84.4% at 1 year. The GPS-adjusted dose-response function showed that MLA was inversely associated with restenosis risk. The upper limit of 95% confidence interval (CI) of the slope was lower than 0 between 10.6 and 17.0 mm2 of MLAs. The 1-year cumulative incidence of restenosis was estimated to be 9.8% (95% CI, 5.8%-13.7%) for the 3rd quartile of MLA (16.91 mm2) versus 18.5% (12.3%-24.1%) for the 1st quartile (9.90 mm2), with a hazard ratio of 0.51 (95% CI, 0.39-0.67; p＜0.001). The present GPS analysis suggested that larger IVUS-measured MLA might be associated with lower risk of 1-year restenosis after DCB treatment for FP lesions.