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Corballis, Natasha, Natarajan, Rajkumar 
ORCID: https://orcid.org/0000-0001-8636-8452, Merinopoulos, Ioannis, Tsampasian, Vasiliki, Clark, Allan ORCID: https://orcid.org/0000-0003-2965-8941, Eccleshall, Simon and Vassiliou, Vassilios S. ORCID: https://orcid.org/0000-0002-4005-7752
(2026)
Drug coated balloons versus drug eluting stents for de novo coronary artery disease: a systematic review and meta-analysis of randomised controlled trials.
eClinicalMedicine.
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Abstract
Background: Drug coated balloon (DCB) only percutaneous coronary intervention (PCI) has an established evidence base in small vessel de novo disease, but recent randomised studies have investigated its use across a broader spectrum of coronary disease. We systematically reviewed randomised evidence comparing DCB with drug eluting stent (DES) PCI for de novo coronary disease. Methods: This systematic review and meta-analysis was conducted in line with the PRISMA statement. PubMed, Scopus, and Embase were systematically searched from inception until 30th May 2026 for randomised trials comparing DCB with DES PCI for de novo coronary disease. Principal outcomes were cardiovascular death, myocardial infarction (MI) and revascularisation. Random-effects models generated odds ratios with 95% confidence intervals. Heterogeneity was assessed using I2 and publication bias by visual inspection of funnel plots. Risk of bias was assessed using Cochrane RoB2. This study was prospectively registered with PROSPERO (CRD420251167202). Findings: Ten RCTs including 7832 patients were identified. There was no significant difference between DCB and DES in cardiovascular death [OR 1.06 (0.75–1.49), p = 0.76, I2 = 0%] or MI [OR: 1.02 (0.76–1.36), p = 0.91, I2 = 0%]. These findings remained consistent after excluding small-vessel-only trials. Revascularisation did not differ across all trials [OR 1.39 (0.88, 2.20), p = 0.16, I2 = 57%] but was higher with DCB after excluding small-vessel-only trials [OR 1.84 (1.06–3.19), p = 0.03, I2 = 54%]. This finding was sensitive to exclusion of REC-CAGEFREE I. Visual inspection of funnel plots did not suggest substantial publication bias. Interpretation: DCB and DES strategies had comparable rates of cardiovascular death and MI across the studied de novo coronary populations. The higher revascularisation rates observed after excluding small-vessel-only trials requires cautious interpretation given between-study heterogeneity and sensitivity to one trial. Further adequately powered RCTs with longer follow-up are required to establish the efficacy of DCB strategies in large vessels and more complex coronary lesions.
| Item Type: | Article |
|---|---|
| Additional Information: | Data sharing statement: All data used in this manuscript can be found in the online versions of studies that were accessed. Our own data synthesis is available upon reasonable request to the corresponding author after publication. Access to the data will require a signed data sharing form. |
| Uncontrolled Keywords: | drug-coated balloon,drug eluting stent,percutaneous coronary intervention,das in place,data sharing statement all data used in this manuscript can be found in the online versions of studies that were accessed. our own data synthesis is available upon reasonable request to the corresponding author after publication. access to the data will require a signed data sharing form.,2026 ,/dt/atira/pure/keyword/DAStatement/das_in_place |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health Faculty of Medicine and Health Sciences > Research Centres > Public Health Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Science > Research Groups > Statistics Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health Faculty of Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre |
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| Depositing User: | LivePure Connector |
| Date Deposited: | 03 Nov 2026 11:10 |
| Last Modified: | 06 Nov 2026 00:05 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/104965 |
| DOI: | 10.1016/j.eclinm.2026.104204 |
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