Abstract

Introduction: Endovascular therapy (EVT) with drug coated balloon (DCB) has been proven superior to balloon angioplasty only in the patency rate. EVT with drug eluting stent (DES) also has shown to be superior to balloon angioplasty only or implantation of bare metal stents. Primary patency of EVT in femoropopliteal lesions (FP-EVT) for DES and DCB is around 80%-90% at 12 months respectively. Therefore, the use of drug technology for FP-EVT is reasonable and generally accepted. However, in daily clinical practice, some target lesion failure (TLF) cases show worse clinical and/or angiographic conditions than the original before the intervention, and many of those cases have bad outcomes. There are no reports on predictors of the worse condition. Methods: A total of 292 consecutive FP lesions of 194 patients who visited our hospital from April 2017 to March 2021 and underwent FP-EVT with drug technologies (DES: 104, DCB: 188) were retrospectively reviewed. "Worsening target lesion failure (WTLF)" was defined as TLF with acute limb ischemia symptom or occlusion of the lesion which had been stenosis at the initial treatment. We investigated the predictor of WTLF. Results: The mean age of all study patients was 72.5±9.3 years and 68% were male. During the follow-up period (median: 568 days), 13 WTLFs were observed. 9 (8.7%) cases were treated with DES and 4 (2.1%) were with DCB at the initial treatment (p=0.01). Cases with WTLF had severer and longer calcification (bilateral calcification: 84.6% vs. 47.7%, p=0.007; calcium length: 162±74mm vs. 85±11mm, p=0.005). Multivariate Cox regression analysis indicated that DES use (Hazard ratio (HR)=4.66, 95% confidence interval [1.28-16.92], p=0.046) and bilateral calcification (HR=7.21, [1.04-50.14], p=0.020) were independently associated with the occurrence of the WTLF. The prevalence of composite outcome, major amputations and all cause deaths, was 54% in the group with WTLF, which was higher than the group without WTLF (p=0.02). Conclusions: Patients with WTLF had bad outcomes. Bilateral calcification and DES deployment were associated with an increased risk for WTLF. For stenotic lesions with bilateral calcification, it may be better to avoid DES deployment.

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