ArticleEuropean heart journal2020
Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis.
Article in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 7 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
67 citing papers in PubMed, 7 syntheses or guidelines pooled it, 186 citations in OpenAlex.
- Sex Differences Among Young Patients With ST-Segment-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis.Journal of the American Heart Association · 2026Pooled it
- Drug-coated Balloons in the Neurovascular Setting: A Comprehensive, Systematic Review of Current Use and Indications.Reviews in cardiovascular medicine · 2022Pooled it
- The Safety of Paclitaxel-Coated Devices for Patients with Peripheral Artery Disease.Current cardiology reports · 2021Pooled it
- Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel.Journal of vascular surgery · 2021Pooled it
- Comparison of efficacy and safety of drug-eluting versus uncoated balloon angioplasty for femoropopliteal arterial occlusive disease: a meta-analysis.BMC cardiovascular disorders · 2020Pooled it
- Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.Circulation · 2020Pooled it
- Clinical and Angiographic Outcomes With Drug-Coated Balloons for De Novo Coronary Lesions: A Meta-Analysis of Randomized Clinical Trials.Journal of the American Heart Association · 2020Pooled it
- Long-Term Follow-up and Mortality Rate of Patients of the Randomized Freeway Stent Study.Cardiovascular and interventional radiology · 2024Trial
- Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.Cardiovascular and interventional radiology · 2022Trial
- Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD.Journal of the American College of Cardiology · 2021Trial
- Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Trial
- COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions.European heart journal · 2020Trial
- Paclitaxel Efficacy in Dialysis-Dependent Peripheral Artery Disease: A National Cohort Analysis.Journal of the American Heart Association · 2026Article
- Article
- State-of-the-Art Definitive Femoropopliteal Lesion Treatment: A Case-Based Systematic Approach.Journal of cardiovascular development and disease · 2026Review
- The ups and downs of paclitaxel-coated balloons and paclitaxel eluting stents: do the conclusions of SWEDEPAD 2 change our practice? Should we be concerned about mortality (again)?CVIR endovascular · 2026Article
- Article
- Impact of Femoropopliteal Drug-Coated Balloon Use on Clinical Outcomes in Patients With Chronic Limb-Threatening Ischemia.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Observational
- Femoropopliteal Interventions for Peripheral Artery Disease: A Review of Current Evidence and Future Directions.Interventional cardiology clinics · 2025Review
- [Peripheral artery disease II: femoropopliteal lesions].Innere Medizin (Heidelberg, Germany) · 2025Review
7 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsDrug-eluting devices (DED) represent a well-established therapy being widely used for endovascular revascularization (EVR) of peripheral vessels. Recent data indicate a two-fold increased long-term mortality in patients treated with paclitaxel-based DED. The subsequent safety concerns affected international regulatory authorities to enunciate several alerts for further application of DED. METHODS AND
resultsIn 9.2 million insurants of the German BARMER Health Insurance, data on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) were retrieved from their introduction on the market in 2007 until present. All patients with first EVR between 2007 and 2015 were indexed and followed until 31 December 2017. Each subsequently applied DES, DCB, bare-metal stent, and uncoated balloon was included in further analyses. Multivariable Cox regression analysis considered potential non-linear time-dependent hazard ratios (HRs) of DES and DCB over 11 years. We identified 64 771 patients who underwent 107 112 EVR procedures using 23 137 DED. Multivariable Cox regression analysis showed paclitaxel-based DES not to be associated with increased long-term mortality for over 11 years past application (all P > 0.057). DCB was associated with decreased long-term mortality for the first year past application (HR 0.92; P < 0.001), and indifferent correlation in the years thereafter (all P > 0.202).
conclusionOur real-world analysis showed no evidence for increased mortality associated with paclitaxel-based DED for over 11 years.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.