ArticleTrials2021
Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04475783 (Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery), which is not on this map. Cited by 15 papers.
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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.
Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery
Who cites it
15 citing papers in PubMed, 26 citations in OpenAlex.
- Subgroup variations in effectiveness of femoropopliteal sirolimus versus paclitaxel-coated balloon angioplasty: post hoc results of the randomised SIRONA trial.CVIR endovascular · 2026Article
- State-of-the-Art Definitive Femoropopliteal Lesion Treatment: A Case-Based Systematic Approach.Journal of cardiovascular development and disease · 2026Review
- Advances in Drug-Eluting Angioplasty Balloon Coatings, Clinical Implications and Future Directions: A Mini Review.Current vascular pharmacology · 2026Review
- Coronary Angioplasty with Drug-Coated Balloons: Pharmacological Foundations, Clinical Efficacy, and Future Directions.Medicina (Kaunas, Lithuania) · 2025Review
- Limus Devices for the Treatment of SFA: Latest Outcomes and Future Perspectives.Journal of clinical medicine · 2025Review
- [Peripheral artery disease II: femoropopliteal lesions].Innere Medizin (Heidelberg, Germany) · 2025Review
- Evaluation of a new Everolimus-coated balloon catheter in an in-vivo porcine peripheral venous model.CVIR endovascular · 2025Article
- Real-World 12-Month Outcomes with Sirolimus-Coated Balloon Angioplasty for Complex Femoropopliteal Disease.Journal of clinical medicine · 2025Article
- Safety and Efficacy of a Paclitaxel-Coated Balloon for the Treatment of Symptomatic Patients with Long Superficial Femoral Artery Disease.Vascular health and risk management · 2025Observational
- Sirolimus coated balloon for the treatment of femoropopliteal lesions: the new kid on the block is getting older 'step by step'.Cardiovascular diagnosis and therapy · 2024Article
- Sirolimus-coated balloons for peripheral arterial disease: walking free into the future of endovascular treatment.Cardiovascular diagnosis and therapy · 2024Article
- Utility of sirolimus coated balloons in the peripheral vasculature - a review of the current literature.CVIR endovascular · 2022Review
- Clinical Use of Hydrogen Sulfide to Protect Against Intimal Hyperplasia.Frontiers in cardiovascular medicine · 2022Review
- Efficacy and safety of drug-coated balloon versus non-drug-coated balloon combined with bare metal stent implantation in treatment of patients with occlusions of the superficial femoral artery: a retrospective study in clinical practice.American journal of translational research · 2022Article
- Vascular smooth muscle cells in intimal hyperplasia, an update.Frontiers in physiology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEndovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty.
methodsThis randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months. DISCUSSION: Although concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated.
trial registrationClinicalTrials.gov NCT04475783 . Registered on 17 July 2020 EUDAMED No. CIV-20-11-035172, DRKS00022452.
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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.