Coronary disease & ACSMeta-analysis
Individual patient data meta-analysis of paclitaxel-coated balloons vs. drug-eluting stents for small-vessel coronary artery disease: the ANDROMEDA study
- Individual patient data meta-analysis of randomised trials
- collaborative
- investigator-initiated
Authors' conclusion
In patients undergoing PCI for de novo SV-CAD, PCB angioplasty is associated with a reduction in MACE and a non-significant difference in TLF at 3 year follow-up compared with DES implantation.
Study context
- Population
- Patients undergoing percutaneous coronary intervention (PCI) for de novo small-vessel CAD
- Participants
- 1,154 patients · 3 RCTs · 1,360 lesions
- Comparison
- Paclitaxel-coated balloon (PCB) angioplasty vs drug-eluting stent (DES) implantation
- Outcome
- MACE (primary) and target lesion failure (co-primary)
- Follow-up
- 3 years
Pooled result
As reported in the abstract
Hazard ratio
0.67
95% CI 0.47–0.96
PCB vs DES
HR 0.67 (95% CI 0.47–0.96)
Further pooled results
| Outcome | HR (95% CI) | |
|---|---|---|
| TLF, PCB vs second-generation DES · 3 years · second-generation DES only; no significant difference | 1.03 (0.70–1.50) | |
| 0.512Hazard ratio (log scale) |
Major adverse cardiac events (MACE), multivariable-adjusted · 3 years
- Benefit persisted after multivariable adjustment
- HR 0.75, 95% CI 0.58-0.96
MACE, two-stage analysis · 3 years
- Did not reach statistical significance in the two-stage analysis
- HR 0.67, 95% CI 0.43-1.04
MACE, landmark analysis
- Risk of MACE between groups consistent over time
Target lesion failure (TLF), sensitivity analysis including reconstructed data from a fourth trial (1384 patients, 1590 lesions)
- Consistent results in terms of TLF
- HR 0.87, 95% CI 0.63-1.20
Original publication
Individual patient data meta-analysis of paclitaxel-coated balloons vs. drug-eluting stents for small-vessel coronary artery disease: the ANDROMEDA study. Eur Heart J. Published 21 February 2025. doi:10.1093/eurheartj/ehaf002
Summarised from the published abstract; every number is checked against it