Background: Paclitaxel-coated balloons (DCB) are suitable to reduce the risk of restenosis after angioplasty of atherosclerotic femoropopliteal lesions. However, numerous types of DCBs are distinguished by drug density and coating. Conflicting evidence exists about the risk of mortality. This study sought to evaluate benefit and risk of DCB angioplasty compared to plain old balloon angioplasty (POBA). Methods: Randomised trials published between January 1, 2005 and February 3, 2019 were identified by searching MEDLINE, CENTRAL, and Clinical.trials.gov. Studies on DCB versus POBA for the treatment of femoropopliteal artery disease were included, and those focused on in-stent restenosis or critical limb ischemia were excluded. Random-effects meta-analysis was conducted to assess the main outcomes of freedom from target lesion revascularisation (FfTLR) and all-cause mortality. Findings: Of 552 identified records, 14 studies including 2504 patients were eligible. DCB significantly increased the risk of FfTLR with substantial heterogeneity (12-month: risk ratio [RR] 1 •24 [95% CI 1 •14-2 •27], I 2 = 66%; 24-month RR 1 •39 [95% CI 1 •39-1 •52], I 2 = 21%). The risk of 24-month all-cause mortality was increased after DCB (random-effects model: RR 1 •53 [95% CI 0 •94-2 •50], p = 0 •09; fixed-effect model: RR 1 •74 [95% CI 1 •08-2 •81], p = 0 •02). Interpretation: Efficacy of DCB differs substantially across studies. Effect size depends on the type of DCB, treatment strategy, and lesion complexity. The risk of 2-year all-cause mortality at 2 years was increased, but without evidence of causation.

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Purpose To evaluate the response rate and safety of superselective drug-eluting beats transarterial chemoembolization (DEB-TACE) with doxorubicin-loaded 40-µm microspheres in patients with hepatocellular carcinoma (HCC). Methods One hundred and forty-one treatments with doxorubicin-loaded 40-µm microspheres in 83 patients between 2012 and 2017 were retrospectively evaluated. Images of the treated lesions were analyzed before and after each treatment according to mRECIST (modified Response Evaluation Criteria in Solid Tumors). Therapy response (complete response [CR] + partial response [PR]) and disease control (CR + PR + stable disease [SD]) rates were determined, and the correlation between the longitudinal axis (longest diameter of the tumor) and volume was investigated using a newly developed software for systematic tumor response assessment. Additional endpoints were progression-free survival (PFS) and time to progression (TTP). Results In the target tumors, a therapy response rate of 63.1% and a disease control rate of 95.7% were achieved. There was a good correlation between the measurement of the longitudinal axis and volume of the measured lesion (r value, 0.954). The median PFS was 2.23 months, and the median TTP was 5.91 months. The serious adverse event rate (SAE) was 10.64%. Conclusion Superselective DEB-TACE with 40-µm sized Embozene Tandem™ can be considered an effective and safe treatment, given the number of procedure-related complications.