Purpose Recently, two meta-analyses concluded that there appears to be an increased risk of long-term mortality of paclitaxel-coated balloons and stents in the superficial femoral and popliteal artery, and paclitaxel-coated balloons below the knee. In this post hoc study of the PADI Trial, we investigated the long-term safety of first-generation paclitaxel-coated drug-eluting stents (DES) below the knee and the dose–mortality relationships of paclitaxel in patients with chronic limb-threatening ischemia (CLI). Materials and Methods The PADI Trial compared paclitaxel-coated DES with percutaneous transluminal angioplasty with bail-out bare-metal stents (PTA ± BMS) in patients with CLI treated below the knee. Follow-up was extended to 10 years after the first inclusion, and survival analyses were performed. In addition, dose-related mortality and dose per patient weight-related mortality relations were examined. Results A total of 140 limbs in 137 patients were included in the PADI Trial. Ten years after the first inclusion, 109/137 (79.6%) patients had died. There was no significant difference between mortality in the DES group compared with the PTA ± BMS group (Log-rank p value = 0.12). No specific dose-related mortality (HR 1.00, 95% CI 0.99–1.00, p = 0.99) or dose per weight mortality (HR 1.05, 95% CI 0.93–1.18, p = 0.46) relationships were identified in the Cox-proportional Hazard models or by Kaplan–Meier survival analyses. Conclusions There is a poor 10-year survival in both paclitaxel-coated DES and PTA ± BMS in patients with CLI treated below the knee. No dose-related adverse effects of paclitaxel-coated DES were observed in our study of patients with CLI treated below the knee. Level of Evidence The PADI Trial: level 1, randomized clinical trial

Aim: To identify predictors of postoperative ascites after liver resection for patients with or without preoperative portal vein embolization (PVE). Methods: Patients undergoing PVE prior to hepatectomy (PVE group; n = 37) were compared with patients who underwent liver resection without PVE (n = 503). Ascites was defined as postoperative daily drainage of clear ascitic fluid exceeding 200 ml/day. Pre-, intra-, and postoperative variables were retrospectively analyzed using uni- and multivariate analyses. Results: Postoperative ascites was present in 13.5% (5/37) of patients who underwent PVE before hepatectomy, compared to 5.8% (29/503) in the group undergoing liver resection without PVE (p = 0.061). In all patients, cirrhosis (OR 54.505, p < 0.001), operation time (OR 1.004, p = 0.014), and the use of the Pringle maneuver (OR 2.336, p = 0.041) were independent risk predictors for ascites in multivariate analysis. In PVE patients, cirrhosis (OR 0.156, p < 0.001) was the only independent significant predictor of ascites after resection. In patients undergoing liver resection without PVE, independent risk factors with multivariate analysis were operation time (OR 1.005, = 0.001) and cirrhosis (OR 26.609, p < 0.001). Conclusion: Operation time and the use of the Pringle maneuver were significant predictors of ascites after hepatectomy. Cirrhosis was a significant risk factor associated with postoperative ascites.

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