Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024
Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.
Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04733443 (A Prospective, Multicenter, Non-inferior, Randomized Controlled Clinical Trial Comparing the Safety and Efficacy of Sequent ® Please Neo With Biolimus-released Coronary Balloon Catheter in the Treatment of Coronary Stent Restenosis), which is not on this map. Cited by 16 papers, 3 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.
A Prospective, Multicenter, Non-inferior, Randomized Controlled Clinical Trial Comparing the Safety and Efficacy of Sequent ® Please Neo With Biolimus-released Coronary Balloon Catheter in the Treatment of Coronary Stent Restenosis
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Drug-coated balloons in coronary in-stent restenosis: a systematic review and meta-analysis comparing sirolimus and biolimus with paclitaxel platforms.Cardiovascular intervention and therapeutics · 2026Pooled it
- Limus- versus paclitaxel-coated balloons for coronary in-stent restenosis: meta-analysis of randomized controlled trials.Cardiovascular intervention and therapeutics · 2026Pooled it
- A meta-analysis of the efficacy of limus-coated balloons vs. paclitaxel-coated balloons for coronary artery disease.Frontiers in cardiovascular medicine · 2026Pooled it
- Final 2-Year Results of the REFORM Study: A Randomized Trial of Biolimus DCB Versus Paclitaxel DCB for In-Stent Restenosis.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Trial
- 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
- A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Trial
- Drug-coated balloon angioplasty for coronary and peripheral artery disease: latest evidence and clinical indications.Nature reviews. Cardiology · 2026Review
- A novel sirolimus-coated balloon versus a paclitaxel-coated balloon for coronary artery disease: the SELSEQ registry.Clinical research in cardiology : official journal of the German Cardiac Society · 2026Article
- Head-to-head comparison of limus- versus paclitaxel-coated balloons in the treatment of in-stent restenosis: a meta-analysis.AsiaIntervention · 2026Article
- Surface micro-patterned drug-coated balloon enhances early biological efficacy in a porcine coronary in-stent restenosis model.PloS one · 2026Article
- Consensus Statement on Drug-Coated Balloons in Coronary Artery Disease from the Cardiovascular Intervention Association of Thailand.Journal of clinical medicine · 2025Review
- Drug-Coated Balloons: Recent Evidence and Upcoming Novelties.Journal of cardiovascular development and disease · 2025Review
- From Mechanisms to Management: Tackling In-Stent Restenosis in the Drug-Eluting Stent Era.Current cardiology reports · 2025Review
- Recent Advances in the Treatment of Coronary In-Stent Restenosis.Reviews in cardiovascular medicine · 2024Review
- Contemporary Use of Drug-Coated Balloons for Coronary Angioplasty: A Comprehensive Review.Journal of clinical medicine · 2024Review
- Angioplasty with drug-coated balloon catheters: the coming tide?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice.
aimsThe study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB).
methodsThis was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients.
resultsA total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm
conclusionsThis head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).
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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.