SynthesisCirculation2020
Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.
Synthesis in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04647643 (Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease), which is not on this map. Cited by 62 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Who cites it
62 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Liquid Drug Delivery Approaches for the Treatment of Occlusive Arterial Disease: A Systematic Review.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2024Pooled it
- Robustness of Longitudinal Safety and Efficacy After Paclitaxel-Based Endovascular Therapy for Treatment of Femoro-Popliteal Artery Occlusive Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.Annals of vascular surgery · 2024Pooled it
- Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis.PloS one · 2022Pooled it
- Network meta-analysis of drug-coated balloon angioplasty versus primary nitinol stenting for femoropopliteal atherosclerotic disease.Journal of vascular surgery · 2021Pooled 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
- Drug-Coated Balloon for De Novo Coronary Artery Lesions: A Systematic Review and Trial Sequential Meta-analysis of Randomized Controlled Trials.Cardiovascular therapeutics · 2020Pooled it
- Plain versus drug balloon and stenting in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial.BMJ (Clinical research ed.) · 2025Trial
- 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
- Three-year outcomes of the TCD-17187 (Kanshas) drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.CVIR endovascular · 2026Article
- Safety of paclitaxel-coated devices in patients with peripheral artery disease: an updated systematic review and meta-analysis of randomized controlled trials.EClinicalMedicine · 2026Article
- 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
- 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
- Advances in drug-coated balloons for the treatment of coronary artery de novo large-vessel lesions.The Journal of international medical research · 2025Review
- Bioengineering Strategies for Treating Neointimal Hyperplasia in Peripheral Vasculature: Innovations and Challenges.Advanced healthcare materials · 2025Review
- Developing a Scanning Electron Microscopy Approach to Evaluate Paclitaxel Deposition From Drug Coated Balloons in a Human Cadaveric Peripheral Artery Disease Model.EJVES vascular forum · 2025Article
2 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundPaclitaxel-containing devices (PTXDs) significantly reduce reintervention in patients with symptomatic femoropopliteal peripheral artery disease. A recent aggregate-data meta-analysis reported increased late mortality in patients with peripheral artery disease treated with PTXDs. We performed an individual patient data meta-analysis to evaluate mortality.
methodsManufacturers of US Food and Drug Administration-approved and commercially available devices in the United States provided deidentified individual patient data for independent analysis. Cox proportional hazards 1-stage meta-analysis models using intention-to-treat methods were used for the primary analysis. A secondary analysis of recovered missing vital status data was performed. The impact of control crossover to PTXDs, cause-specific mortality, and drug dose mortality were assessed.
resultsA total of 2185 subjects and 386 deaths from 8 PTXD trials with 4-year median follow-up were identified. The primary analysis indicated a 38% (95% CI, 6% to 80%) increased relative mortality risk, corresponding to 4.6% absolute increase, at 5 years associated with PTXD use. Control and treatment arm loss to follow-up and withdrawal were 24% and 23%, respectively. With inclusion of recovered vital status data, the excess relative mortality risk was 27% (95% CI, 3%-58%). This observation was consistent across various scenarios, including as-treated analyses, with no evidence of increased risk over time with PTXDs. Mortality risk tended to be increased for all major causes of death. There were no subgroup differences. No drug dose-mortality association was identified.
conclusionsThis individual patient data meta-analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, identified an absolute 4.6% increased mortality risk associated with PTXD use.
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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 Socratic graph.