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Outcomes of Drug-Coated Balloon Versus Drug-Eluting Stent for In-Stent Restenosis and De-Novo Lesions: A Meta-Analysis of Randomized Controlled Trials Publisher



Moghadam AS ; Kazemian S ; Shojaei S ; Moghadam SS ; Dolama RH ; Ebrahimi R ; Shirmard FO ; Pourfaraji SMA ; Najafi MS ; Hobaby S ; Soleimani H ; Tajdini M ; Tehrani B ; Kolte D Show All Authors
Authors
  1. Moghadam AS
  2. Kazemian S
  3. Shojaei S
  4. Moghadam SS
  5. Dolama RH
  6. Ebrahimi R
  7. Shirmard FO
  8. Pourfaraji SMA
  9. Najafi MS
  10. Hobaby S
  11. Soleimani H
  12. Tajdini M
  13. Tehrani B
  14. Kolte D
  15. Elgendy I
  16. Basavarajaiah S
  17. Latib A
  18. Sattar Y
  19. Chadi Alraies M
  20. Hosseini K

Source: Health Science Reports Published:2026


Abstract

Background and Aims: Drug-coated balloons (DCBs) and drug-eluting stents (DESs) are commonly used in percutaneous coronary interventions (PCI), but their long-term comparative effectiveness remains unclear. This meta-analysis aimed to compare the clinical and angiographic outcomes of DCB versus DES in patients with in-stent restenosis (ISR) and de novo lesions, including ST-elevation myocardial infarction (STEMI) and small vessel disease (SVD). Methods: A systematic search identified randomized controlled trials (RCTs) comparing DCBs and DESs. The primary outcome was target lesion revascularization (TLR), with secondary outcomes including all-cause mortality, cardiovascular mortality, myocardial infarction, stent/lesion thrombosis, and late lumen loss (LLL). The frequentist network meta-analysis and binary random-effect analysis were used to compare DCB versus. DES. Results: A total of 21 RCTs with 4244 patients were included. In ISR patients, the risk of TLR was comparable between DCB vs. DES at 1-year (OR: 1.36, 95% CI: 0.86–2.14) and beyond 1-year (OR: 1.23, 95% CI: 0.79–1.93). DCB and DES showed no significant difference in other secondary outcomes at 1-year and beyond. In STEMI and SVD patients, DCB and DES demonstrated similar outcomes, except for a lower LLL after DCB in patients with SVD (SMD: −0.38, 95% CI: −0.53 to −0.22). Conclusion: DCB and DES were associated with a similar risk of TLR in patients with ISR, STEMI, and SVD. The results were consistent at 1-year and beyond time intervals. Furthermore, DCB was associated with a lower LLL compared to DES in patients with SVD. © 2026 The Author(s). Health Science Reports published by Wiley Periodicals LLC.