Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2025
Sirolimus-coated versus paclitaxel-coated balloons for bifurcated coronary lesions in the side branch: the SPACIOUS trial.
Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Hybrid drug-coated balloon strategy for coronary bifurcation lesions: a systematic review and meta-analysis.BMJ open · 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
- A meta-analysis of the efficacy of limus-coated balloons vs. paclitaxel-coated balloons for coronary artery disease.Frontiers in cardiovascular medicine · 2026Pooled it
- Drug-Coated Balloon Angioplasty for Isolated Medina 0,0,1 Ostial Side-Branch Lesions: Procedural Outcomes, Bailout Stenting, and 12-Month Clinical Follow-Up.Medicina (Kaunas, Lithuania) · 2026Observational
- 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
- Drug-coated balloon angioplasty in coronary artery disease: state of the art review.NPJ cardiovascular health · 2026Review
- 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
- Association of estimated pulse wave velocity with outcomes following drug-coated balloon therapy in elderly coronary artery disease patients.Frontiers in cardiovascular medicine · 2026Article
- A prospective randomized open-label trial of sirolimus versus paclitaxel-coated balloons for the side branch ofJournal of thoracic disease · 2025Article
- Consensus Statement on Drug-Coated Balloons in Coronary Artery Disease from the Cardiovascular Intervention Association of Thailand.Journal of clinical medicine · 2025Review
- Paclitaxel- or sirolimus-coated balloons for coronary bifurcations: is the side branch SPACIOUS enough for both?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Article
Corrections and comments
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe optimal strategy to treat coronary bifurcation lesions (CBL) has been a long-debated topic. The combination of a stent in the main vessel (MV) and a drug-coated balloon (DCB) in the side branch (SB) seems promising, but the evidence is limited.
aimsThis study aims to investigate a novel sirolimus-coated balloon in the treatment of non-left main CBL compared with a paclitaxel-coated balloon.
methodsThe SPACIOUS trial is a prospective, non-inferiority, multicentre trial. A total of 230 patients were randomised to the sirolimus DCB or the paclitaxel DCB group in a 1:1 ratio. Angiographic and clinical follow-ups were planned at 9 months and 1 year, respectively. The primary endpoint was diameter stenosis (DS) in the SB at 9 months.
resultsAt 9 months, DS in the sirolimus group was 30.5±16.1% compared with 33.5±16.2% in the paclitaxel group (difference -2.94%; 95% confidence interval: -7.62% to 1.74%; p for non-inferiority<0.01). The incidence of binary restenosis was significantly lower in the sirolimus group compared to the paclitaxel group (4.4% vs 12.8%; p=0.043). Secondary angiographic endpoints, including late lumen loss and net lumen gain, and 1-year clinical outcomes were not significantly different between groups.
conclusionsIn de novo non-left main CBL treatment, MV stenting accompanied by SB dilation with the sirolimus DCB was non-inferior to the paclitaxel DCB.
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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 Socratic graph.