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Two-Year Mortality After Angioplasty of the Femoro-Popliteal Artery with Uncoated Balloons and Paclitaxel-Coated Balloons—A Pooled Analysis of Four Randomized Controlled Multicenter Trials

  • Albrecht, Thomas1, 2
  • Schnorr, Beatrix3
  • Kutschera, Maren3
  • Waliszewski, Matthias W.4, 5
  • 1 Vivantes Hospital Neukölln, Department of Radiology and Interventional Therapy, Neukölln Vascular Centre, Berlin, Germany , Berlin (Germany)
  • 2 Vivantes Klinikum Neukölln, Institut für Radiologie und Interventionelle Therapie, Rudower Str. 48, Berlin, 12351, Germany , Berlin (Germany)
  • 3 Charité – Universitätsmedizin Berlin, Experimental Radiology, Department of Radiology, Berlin, Germany , Berlin (Germany)
  • 4 B. Braun Melsungen AG, Medical Scientific Affairs, Berlin, Germany , Berlin (Germany)
  • 5 Charité – Universitätsmedizin Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum, Berlin, Germany , Berlin (Germany)
Published Article
CardioVascular and Interventional Radiology
Publication Date
Mar 06, 2019
DOI: 10.1007/s00270-019-02194-w
Springer Nature


PurposeIn view of a recent meta-analysis reporting increased mortality following angioplasty with paclitaxel-coated devices in peripheral arteries, we performed a patient-level 2-year mortality analysis based on pooled original data of four randomized controlled trials (THUNDER, FEMPAC, PACIFIER and CONSEQUENT).Methods and ResultsClinical data of four randomized controlled trial were pooled to assess 2-year mortality following paclitaxel-coated balloon (PCB) angioplasty compared to angioplasty without paclitaxel (control group). A logistic regression model was applied to identify potential predictors of mortality. At two years, 13 of 185 (7.0%) patients had died in the control group and 16/184 (8.7%) in the PBC group, p = 0.55. Kaplan–Meier analysis revealed no significant difference from all-cause death at 2 years (log rank p = 0.54). Causes of death were well balanced between the groups with no pattern or trend in favour of any specific causes in the PBC group. Logistic regression revealed that treatment groups (controls or PBC) were not a predictor of 2-year mortality. The only predictor for mortality was patient age ≥ 75 years. The delivered paclitaxel doses per patient were not significantly different in patients that died and those who did not die during the 24-month follow-up (5.300 ± 4.224 μg vs. 6.248 ± 4.629 μg, p = 0.433).ConclusionsBased on original patient-level data of four pooled randomized controlled trials, we found no increase in 2-year mortality in patients treated with PCB compared to control patients treated with uncoated balloons. Causes of death were well balanced between PCB and control patients.

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