Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND in-stent restenosis (ISR)): a randomised, non-inferiority trial
Primary resultResult — go to the resultMean difference −0.02 mm 95% CI −0.12 to 0.07Authors' conclusion
This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB.
Study context
- Population
- Patients with coronary drug-eluting stent (DES) in-stent restenosis
- Participants
- 280 patients17 centres
- Comparison
- Biolimus-coated balloon vs paclitaxel-coated balloon
- Biolimus-coated balloon (BCB)n = 140
- Paclitaxel-coated balloon (PCB)n = 140reference
- Primary endpoint
- In-segment late lumen loss (independent core laboratory)
- Follow-up
- 9 months
Methodological detailsprospective, multicentre, non-inferiority
- Prospective
- Multicentre
- Non-inferiority
Primary result
As reported in the abstract
Mean difference
−0.02 mm
95% CI −0.12 to 0.07
P < 0.0001 for non-inferiority
By group
BCBvs PCB
mean difference −0.02 mm (95% CI −0.12 to 0.07); P < 0.0001 for non-inferiority
Further findings
| Outcome | BCB | PCB | Mean difference (mm²) (95% CI) | P value | |
|---|---|---|---|---|---|
| Neointimal area (OCT substudy) · 9 monthsPrespecified subgroup | 2.32 ± 1.04 mm² | 2.37 ± 0.93 mm² | −0.09 (−0.94 to 0.76) | P = non-significant | |
| −1−0.500.51Difference, mm² (linear scale) |
Clinical outcomes · 12 months
- Similar clinical outcomes in both groups
Original publication
Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial. EuroIntervention. Published 1 July 2024. doi:10.
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