Abstract

Aim: The predictors of restenosis after endovascular therapy (EVT) with paclitaxel drug-coated balloons (DCBs) have not been clearly established. The present study aimed to investigate the association of post-procedural dissection, as evaluated using intravascular ultrasound (IVUS), with the risk of restenosis following femoropopliteal EVT with paclitaxel DCBs. Methods: In the present single-center retrospective study, 60 de novo femoropopliteal lesions (44 patients) that underwent EVT with DCBs, without bail-out stenting, were enrolled. The primary outcome was 1-year primary patency. Risk factors for restenosis were evaluated using a Cox proportional hazards regression model and random survival forest analysis. Results: The 1-year primary patency rate was 57.2% [95% confidence interval, 45%–72%]. IVUS-evaluated post-procedural dissection was significantly associated with the risk of restenosis ( P =0.002), with the best cutoff point of 64º [range, 39º–83º]. The random survival forest analysis showed that the variable importance measure of IVUS-evaluated dissection was significantly lower than that of the reference vessel diameter ( P <0.001), not different from that of the lesion length ( P =0.41), and significantly higher than that of any other clinical feature (all P <0.05). Conclusion: IVUS-evaluated post-procedural dissection was associated with 1-year restenosis following femoropopliteal EVT with DCB.

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