Coronary disease & ACSMeta-analysis
Drug-coated balloons versus drug-eluting stents for de novo coronary lesions: a systematic review and meta-analysis of randomised trials
- systematic review and meta-analysis of randomised controlled trials
- random-effects models (DerSimonian-Laird method with Hartung-Knapp adjustment)
- Cochrane Risk of Bias 2 tool
Authors' conclusion
DCB angioplasty shows comparable short-term safety and efficacy to modern DES for de novo coronary disease. Long-term follow-up is necessary to confirm whether avoidance of permanent implants translates into clinical benefit.
Study context
- Population
- Adult patients with de novo coronary lesions undergoing percutaneous coronary intervention (PCI), in trials reporting clinical outcomes at ≥9 monthspatients in seven trials · drug-coated balloon (DCB) 3,570 · drug-eluting stents (DES) 3,568
- Participants
- 7,138 patients
- Comparison
- DCB angioplasty with DES for de novo coronary lesions
- DCBn = 3,570
- DESn = 3,568reference
Pooled result
As reported in the abstract
Device-oriented composite endpoint:
- Cardiac death
- Target vessel myocardial infarction
- Target lesion revascularisation
Relative risk
1.02
95% CI 0.63–1.64
P = 0.93
DCB vs DES
RR 1.02 (95% CI 0.63–1.64); P = 0.93
Further pooled results
| Outcome | RR (95% CI) | |
|---|---|---|
| Secondary outcomes — DCB vs DES · cardiac death | 1.26 (0.75–2.14) | |
| Secondary outcomes — DCB vs DES · target vessel MI | 0.71 (0.36–1.39) | |
| Secondary outcomes — DCB vs DES · target lesion revascularisation | 1.09 (0.52–2.30) | |
| Secondary outcomes — DCB vs DES · target vessel revascularisation | 0.98 (0.58–1.65) | |
| 0.20.5125Relative risk (log scale) |
Secondary outcomes
- Secondary outcomes were comparable
Sensitivity analysis
- Sensitivity analysis supported the stability of the primary findings
Trials using sirolimus coated balloons (subgroup)
- Trials using sirolimus coated balloons demonstrated similar results
Original publication
Drug-coated balloons versus drug-eluting stents for de novo coronary lesions: a systematic review and meta-analysis of randomised trials. Heart. Published 20 July 2026. doi:10.1136/heartjnl-2026-328324
Summarised from the published abstract; every number is checked against it