Trial reportCardiovascular drugs and therapy2022
A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions.
Trial report in Cardiovascular drugs and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 29 papers, 7 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 7 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Drug Coated Balloons Versus Drug-Eluting Stents in Patients With De Novo Coronary Artery Disease.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Pooled it
- Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.Clinical research in cardiology : official journal of the German Cardiac Society · 2025Pooled it
- Comparison Between Drug-Coated Balloon and Stents in Large De Novo Coronary Artery Disease: A Systematic Review and Meta-Analysis of RCT Data.Cardiovascular drugs and therapy · 2025Pooled it
- Drug-coated balloons versus drug-eluting stents in patients with small coronary artery disease: an updated meta-analysis.BMC cardiovascular disorders · 2025Pooled it
- Drug-Coated Balloons versus Drug-Eluting Stents for the Treatment of De Novo Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials.Reviews in cardiovascular medicine · 2024Pooled it
- Comparison of Efficacy and Safety Between Drug-Coated Balloons Versus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions in Large Vessels: A Study-Level Meta-Analysis of Randomized Control Trials.Cardiovascular drugs and therapy · 2024Pooled it
- Drug-Coated Balloon-Only Strategy for De Novo Coronary Artery Disease: A Meta-analysis of Randomized Clinical Trials.Cardiovascular therapeutics · 2023Pooled it
- Regional Differences Between Drug-Coated Balloons and Drug-Eluting Stents inCardiology research · 2026Article
- Drug-coated balloon angioplasty for coronary and peripheral artery disease: latest evidence and clinical indications.Nature reviews. Cardiology · 2026Review
- Abbreviated dual antiplatelet therapy after percutaneous coronary intervention with drug coated balloons in acute coronary syndromes: insights from the SWEDEHEART registry.European heart journal. Cardiovascular pharmacotherapy · 2026Observational
- Outcomes of Paclitaxel-Coated Balloon Angioplasty vs. Drug-Eluting Stents in the Management of Acute and Chronic Coronary Syndromes in All Vessel Sizes: A Propensity-Matched Study (The OUTDES Study).Journal of cardiovascular development and disease · 2026Article
- Temporal trends in the use of drug-coated balloons in Poland - an analysis based on the national registry.Cardiology journal · 2026Article
- Drug-Coated Balloons Versus Drug-Eluting Stents for Large Vessel Coronary Artery Disease: A Meta-Analysis.Journal of cardiovascular development and disease · 2025Review
- Review
- Drug-Coated Balloons in All-Comer Population-Are We There Yet?Journal of clinical medicine · 2025Review
- Drug-coated balloons in percutaneous coronary interventions: existing evidence and emerging hopes.Cardiology journal · 2025Review
- Clinical Updates in Coronary Artery Disease: A Comprehensive Review.Journal of clinical medicine · 2024Review
- Chinese expert consensus on the clinical application of drug-coated balloon (2Journal of geriatric cardiology : JGC · 2024Article
- A New Frontier for Drug-Coated Balloons: Treatment of "De Novo" Stenosis in Large Vessel Coronary Artery Disease.Journal of clinical medicine · 2024Review
- Article
Corrections and comments
- Erratum issued
Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
backgroundDrug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes.
methodsIn this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR).
resultsFrom July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was -0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was -0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226).
conclusionsIn this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.
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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.