A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions
Primary result · In-segment LLLResult — go to the resultMean difference 0.07 mm 95% CI −0.12 to 0.26Authors' conclusion
The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB
Study context
- Population
- Patients with de novo coronary lesions, 4 centres in Germany and Switzerland
- Participants
- 70 patients
- Comparison
- Sirolimus-coated balloon vs paclitaxel-coated balloon
- Primary endpoint
- Angiographic late lumen loss (non-inferiority margin δ=0.35 mm)
- Follow-up
- 6 months
Methodological detailsmulticentre, non-inferiority
- Multicentre
- Non-inferiority
Primary result
In-segment late lumen loss (LLL)
Mean difference
0.07 mm
95% CI −0.12 to 0.26
By group
SCBvs PCB
mean difference 0.07 mm (95% CI −0.12 to 0.26)
As reported in the abstract
Safety
| Outcome | SCB | PCB |
|---|---|---|
| Clinical events (TLR, MI, death) · up to 12 months | ||
| Target lesion revascularisations | 2 | 3 |
- Clinical events (TLR, MI, death) — MI
- 0
- Clinical events (TLR, MI, death) — Deaths
- 0
Clinical events (TLR, MI, death) · up to 12 months
- Clinical event rates not different between the groups
Original publication
A randomised trial of sirolimus- versus paclitaxel-coated balloons for de novo coronary lesions. EuroIntervention. Published 4 November 2024. doi:10.
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