Trial reportJACC. Cardiovascular interventions2017
The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes.
Trial report in JACC. Cardiovascular interventions, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 35 papers, 2 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.
Sirolimus Coated Angioplasty Balloon in the Salvage of Thrombosed Arteriovenous Graft
XTOSI Pilot Study: Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA) - Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease
SIroliMus Coated angioPlasty Versus Plain Balloon Angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION)
Randomized Controlled Trial of First Sirolimus Coated Balloon Versus Standard Balloon Angioplasty in The Treatment of Superficial Femoral Artery and Popliteal Artery Disease
FUTURE BTK: Randomized Controlled Trial of First SirolimUs CoaTed Balloon VersUs StandaRd Balloon Angioplasty in The TrEatment of Below The Knee Arterial Disease
A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatment of Dysfunctional Arteriovenous Fistula
MAGICAL BTK: Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease
Who cites it
35 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Drug-coated Balloons in the Neurovascular Setting: A Comprehensive, Systematic Review of Current Use and Indications.Reviews in cardiovascular medicine · 2022Pooled it
- Pooled it
- Sirolimus-coated versus paclitaxel-coated balloons for bifurcated coronary lesions in the side branch: the SPACIOUS trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Trial
- Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Trial
- SirolimusWorld journal of methodology · 2026Article
- Head-to-head comparison of limus- versus paclitaxel-coated balloons in the treatment of in-stent restenosis: a meta-analysis.AsiaIntervention · 2026Article
- Current and future role of drug-coated balloons in the treatment of coronary artery disease.Future cardiology · 2026Article
- Coronary drug-coated balloons: Current evidence and emerging trends.World journal of cardiology · 2025Review
- Drug-Coated Balloons for Coronary Artery Disease: From Theory to Practice.Current treatment options in cardiovascular medicine · 2025Article
- Assessing paclitaxel-coatedWorld journal of cardiology · 2025Article
- Stent Failure Management in Contemporary Clinical Practice.Diagnostics (Basel, Switzerland) · 2025Article
- Drug-Coated Balloons-Based Intervention for Coronary Artery Disease: The Second Report of Asia-Pacific Consensus Group.JACC. Asia · 2025Review
- Leaving Nothing Behind: Expanding the Clinical Frontiers of Drug-Coated Balloon Angioplasty in Coronary Artery Disease.Journal of cardiovascular development and disease · 2025Review
- Safety and Performance of the MOZEC Sirolimus-Eluting Coronary Balloon in the Treatment of Stenotic Coronary Artery Lesions: A Real-World, Multicenter, Post-Marketing Surveillance Study.Cardiology research · 2025Article
- Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives.Korean circulation journal · 2024Review
- Current Management of In-Stent Restenosis.Journal of clinical medicine · 2024Review
- Endovascular Drug Delivery.Life (Basel, Switzerland) · 2024Review
- Plaque heterogeneity and the spatial distributions of its components dictate drug-coated balloon therapy.Scientific reports · 2024Article
- Intrastent Restenosis: A Comprehensive Review.International journal of molecular sciences · 2024Review
- Coatings for Cardiovascular Stents-An Up-to-Date Review.International journal of molecular sciences · 2024Review
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR).
backgroundAngioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR.
methodsIn this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up.
resultsProcedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE.
conclusionsThis first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.
Indexed as
Identifiers
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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.