Author + information
- Received March 6, 2020
- Revision received April 1, 2020
- Accepted April 7, 2020
- Published online September 7, 2020.
- Tanja Böhme, MD∗ (, )@tanja_boehme,
- Elias Noory, MD,
- Ulrich Beschorner, MD,
- Börries Jacques, MD,
- Karlheinz Bürgelin, MD,
- Roland Macharzina, MD,
- Ellen Gebauer, MD,
- Florian Cheung,
- Peter Lechner,
- Thomas Nührenberg, MD and
- Thomas Zeller, MD
- Klink für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg -Bad Krozingen, Bad Krozingen, Germany
- ↵∗Address for correspondence:
Dr. Tanja Böhme, Abteilung Angiologie und Kardiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany.
Objectives This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice.
Background A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.
Methods A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed.
Results Overall, 7,357 patients with femoropopliteal lesions were treated within the study period receiving either DCB angioplasty or POBA. Of those, 1,579 fulfilled the study criteria. A total of 514 patients were treated with POBA without crossover to a paclitaxel-coated device during follow-up and 1,065 patients were treated with DCB angioplasty. Mortality incidence at mean follow-up of 52.0 ± 20.5 months (median 51 months) was 27.8% after POBA and 16.9% after DCB angioplasty (p < 0.001). Equally, for a cohort excluding patients over 80 years of age, the mortality rate after POBA treatment was significantly higher (23.6% vs. 12.3%; p < 0.001). For the entire cohort, independent predictors for mortality were age (p < 0.001), type of treatment (p = 0.009), hyperlipidemia (p = 0.010), diabetes mellitus (p = 0.010), renal insufficiency (p = 0.007), stroke (p = 0.017), and Rutherford-Becker class 4 (p < 0.001). DCB length was not correlated to mortality rate. After propensity score matching, independent mortality predictors were POBA treatment (p = 0.035), age (p < 0.001), stroke (p = 0.025), and renal insufficiency (p = 0.007).
Conclusions In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of femoropopliteal lesions. Known comorbidities, risk factors, and disease severity were identified as mortality predictors but not paclitaxel.
Dr. Noory has received honoraria from BARD, Boston Scientific, Abbott, and Medtronic. Dr. Zeller has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific, Cook Medical, Gore and Associates, Medtronic, Philips-Spectranetics, BIBA Medical, and Shockwave; has served as a consultant for Boston Scientific, Gore and Associates, Medtronic, Veryan, CSI Medical, Intact Vascular, Shockwave, Bayer, and Vesper Medical; has received research, clinical trial, or drug study funds received from 480 Biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore and Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, and B. Braun; and owns common stock in QT Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received March 6, 2020.
- Revision received April 1, 2020.
- Accepted April 7, 2020.
- 2020 American College of Cardiology Foundation
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