Trial reportCardiovascular and interventional radiology2020
Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.
Trial report in Cardiovascular and interventional radiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.
- 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
- Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD.Journal of the American College of Cardiology · 2021Trial
- 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
- Intravascular Imaging and Pathological Features of Drug-Coated Balloon Angioplasty in Atherosclerotic Porcine Peripheral Arteries.Journal of atherosclerosis and thrombosis · 2025Article
- Introducing and utilizing innovative technologies in health care systems: a country comparison for peripheral drug-eluting stents in Germany and the USA.Frontiers in public health · 2025Review
- Comparison of Endovascular Interventions for the Treatment of Superficial Femoral Artery Disease: A Network Meta-analysis.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Review
- Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry.Korean circulation journal · 2024Article
- Limb Salvage and Survival in Chronic Limb-Threatening Ischemia: The Need for a Fast-Track Team-Based Approach.Journal of clinical medicine · 2023Review
- Re-analysis of Old Data and New Outcomes Data Do Not Support a Link Between Paclitaxel Coated Balloons and Paclitaxel Eluting Stents and Mortality: These Devices Should be Used in PAD (Peripheral Arterial Disease) Treatment in Femoropopliteal Disease on the Basis of Their Published Efficacy.Cardiovascular and interventional radiology · 2023Article
- Drug-Coated Balloon versus Drug-Eluting Stent: The Debate of Leave Nothing Behind.Seminars in interventional radiology · 2023Review
- Repetition of Paclitaxel-Coated Devices for the Treatment of Lower Extremity Artery Disease: Mortality Outcomes and Predictors.Acta Cardiologica Sinica · 2023Article
- Data sources and applied methods for paclitaxel safety signal discernment.Frontiers in cardiovascular medicine · 2023Review
- Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2022Article
- Drug-Eluting Stents.Seminars in interventional radiology · 2022Review
- Illuminating the Path for Novel Peripheral Drug-Eluting Stents.JACC. Cardiovascular interventions · 2022Article
- First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study.Frontiers in cardiovascular medicine · 2022Article
- Association of mortality with drug-coated devices in femoropopliteal artery based on the nationwide data.Annals of surgical treatment and research · 2021Article
- Paclitaxel-Coated Devices: Safety and Efficacy Are in the PVI of the Beholder.Journal of the American Heart Association · 2021Article
- Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel-Coated Devices: Insights From the Veterans Health Administration.Journal of the American Heart Association · 2021Article
- Twelve-Month Results From the First-in-China Prospective, Multi-Center, Randomized, Controlled Study of the FREEWAY Paclitaxel-Coated Balloon for Femoropopliteal Treatment.Frontiers in cardiovascular medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 4 countries.
Funding
Abstract
purposePatient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel.
methodsData from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan-Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality.
resultsIn the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality.
conclusionAnalyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality. LEVEL OF EVIDENCE: Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.
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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.