Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024
A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions.
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 NCT03908450 (Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter), which is not on this map. Cited by 22 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.
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Bailout Stenting After Drug-Coated Balloon Angioplasty: Clinical Outcomes and Implications for Contemporary PCI-A Systematic Review and Meta-Analysis.Medicina (Kaunas, Lithuania) · 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
- Comparison of Hybrid Strategy With Drug-Coated Balloons Versus Stent-Only Strategy for Coronary Bifurcation Lesions: A Systematic Review and Meta-Analysis.Cardiovascular therapeutics · 2026Pooled it
- Trial
- Paclitaxel drug-coated balloon angioplasty for de novo coronary lesions in an expanded real world clinical setting: the multicenter ALLIANCE registry.Cardiovascular intervention and therapeutics · 2026Trial
- Article
- Mid-term outcomes of using drug-coated balloon angioplasty for the treatment of large vesselCardiovascular diagnosis and therapy · 2026Article
- Real-World Usage of a Paclitaxel-Coated Balloon With Urea Compared With Other Contemporary Drug-Coated Balloons: A 2-Year Analysis From SCAAR in Over 6000 Patients.Journal of the American Heart Association · 2026Observational
- Different Drugs, Similar Outcomes? Challenging the No-Class-Effect Motto of Drug-Coated Balloon in Coronary Artery Disease.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
- Paclitaxel-Coated Balloons Versus Sirolimus-Coated Balloons for Coronary Artery Lesions: A Nationwide Cohort Study From SCAAR.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Article
- Many roads lead to Rome - the quest for optimal lesion preparation.AsiaIntervention · 2026Article
- Angiographic and functional assessment after paclitaxel or sirolimus drug-coated balloons for de novo coronary artery disease in small vessels: PICCOLETO VI study.AsiaIntervention · 2026Article
- Drug-Coated Balloons in Coronary Bifurcation Disease: A State-of-the-Art Review.Journal of personalized medicine · 2026Review
- Efficacy of Sirolimus Versus Paclitaxel-Coated Balloons for Coronary Revascularization: An Updated Meta-Analysis with GRADE Assessment.Journal of the Saudi Heart Association · 2026Review
- Drug-coated balloons in complex large-vessel coronary artery disease: a comprehensive review of current evidence and future perspectives.Frontiers in cardiovascular medicine · 2026Review
- Assessing paclitaxel-coatedWorld journal of cardiology · 2025Article
- Blended Coronary Revascularization with Drug-Coated Balloon and Drug-Eluting Stent: A Narrative Review on Rationale, Clinical Evidence, and Future Perspectives.Journal of clinical medicine · 2025Review
- Coronary Angioplasty with Drug-Coated Balloons: Pharmacological Foundations, Clinical Efficacy, and Future Directions.Medicina (Kaunas, Lithuania) · 2025Review
- Review
- Drug-coated balloons in small vessel de novo coronary artery disease: better than DES?European heart journal · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPaclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive.
aimsThis randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions.
methodsTo compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints.
resultsQuantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths).
conclusionsThe novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).
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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.