Trial reportCirculation2017
Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH).
Trial report in Circulation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00986752 (Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease), which is not on this map. Cited by 22 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.
Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease
Who cites it
22 citing papers in PubMed, 7 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Drug-coated balloon combined with stent versus stent alone for femoropopliteal disease: a systematic review and meta-analysis.BMC cardiovascular disorders · 2026Pooled 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
- Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.European heart journal · 2023Pooled it
- Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis.PloS one · 2022Pooled it
- Atherectomy for peripheral arterial disease.The Cochrane database of systematic reviews · 2020Pooled 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
- Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of the American Heart Association · 2018Pooled it
- Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty.Cardiovascular and interventional radiology · 2020Trial
- The Role of Atherectomy in Lesion Preparation for Peripheral Artery Disease: Evolution of Technologies, Available Devices, and Contemporary Evidence.Reviews in cardiovascular medicine · 2026Review
- Outcomes of drug-coated balloon combined with stenting vs. stenting alone in the treatment of femoropopliteal artery lesions requiring bailout stenting.BMC surgery · 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
- Algorithm for the Revascularization of Infrainguinal Arterial Disease.Vascular specialist international · 2025Review
- Overview and comparison of contemporary Society for Vascular Surgery, American Heart Association/American College of Cardiology, and European Society for Vascular Surgery guidelines for the management of patients with intermittent claudication.Seminars in vascular surgery · 2024Review
- Prevalence and patterns of in-stent neoatherosclerosis in lower extremity artery disease.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023Article
- Index atherectomy peripheral vascular interventions performed for claudication are associated with more reinterventions than nonatherectomy interventions.Journal of vascular surgery · 2022Article
- Benefit and risk from paclitaxel-coated balloon angioplasty for the treatment of femoropopliteal artery disease: A systematic review and meta-analysis of randomised controlled trials.EClinicalMedicine · 2019Article
- Adverse Events After Atherectomy: Analyzing Long-Term Outcomes of Endovascular Lower Extremity Revascularization Techniques.Journal of the American Heart Association · 2019Article
- Atherectomy-assisted versus percutaneous angioplasty interventions for treatment of symptomatic infra-inguinal peripheral arterial disease.Archives of medical sciences. Atherosclerotic diseases · 2019Review
- Clinical Outcomes and Cost Comparisons of Stent and Non-Stent Interventions in Infrainguinal Peripheral Artery Disease: Insights From the Excellence in Peripheral Artery Disease (XLPAD) Registry.The Journal of invasive cardiology · 2019Article
- Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease.Seminars in interventional radiology · 2018Review
Corrections and comments
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Authors and funding
13 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAtherosclerosis in the superficial femoral artery is common in patients suffering from peripheral artery disease. Paclitaxel-eluting balloon (PEB) angioplasty, stenting, and directional atherectomy (DA) have provided new options for the treatment of superficial femoral artery disease; however, the comparative efficacy of these interventional strategies remains uncertain.
methodsOne hundred and fifty-five patients with symptomatic peripheral artery disease due to de novo superficial femoral artery stenotic or occlusive lesions were randomized to treatment with plain balloon angioplasty (BA) followed by PEB angioplasty and stenting (n=48), BA and stenting (n=52), or DA with distal protection and bailout stenting (n=55). The primary end point of the study was percentage diameter stenosis after 6 months measured by angiography. Other end points included target lesion revascularization, thrombosis, ipsilateral amputation, binary restenosis, and all-cause mortality at 6 and 24 months.
resultsBaseline and lesion characteristics were comparable in all groups with a mean lesion length of 65.9±46.8 mm and 56% total occlusions. At 6 months angiography, the percent diameter stenosis was significantly lower in patients treated by PEB angioplasty and stenting (34±31%) as compared with BA angioplasty and stenting (56±29%,
conclusionsTreatment of de novo superficial femoral artery lesions with PEB angioplasty and stenting is superior to BA angioplasty and stenting or DA in terms of angiographic diameter stenosis at 6 months and target lesion revascularization at 24 months. CLINICAL
trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00986752.
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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.