Coronary disease & ACSRandomised controlled trial
Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis
- Randomised controlled trial
- prospective
- assessor-blinded
- non-inferiority
- 1:1 randomisation
- 16 sites
Authors' conclusion
In this study, a novel SCB was found to be noninferior to a PCB in terms of in-segment LLL at 9 months in treating patients with ISR.
Study context
- Population
- Patients with coronary in-stent restenosis
- Participants
- 258 patients · 285 lesions
- Comparison
- Sirolimus-coated balloon vs paclitaxel-coated balloon
- SCBn = 130
- PCBn = 128reference
- Primary endpoint
- Angiographic in-segment late lumen loss (non-inferiority)
- Follow-up
- 9 months
Primary result
In-segment late lumen loss (LLL)
Difference
0.07 mm
95% CI −0.05 to 0.19
P < 0.0001 for non-inferiority
By group
SCB vs PCB
difference 0.07 mm (95% CI −0.05 to 0.19); P for non-inferiority < 0.0001
Non-inferiority margin 0.2 as printed, not drawn
As reported in the abstract
Secondary outcomes
Clinical outcomes (procedural success, restenosis, target lesion failure) · 12 months
- No significant differences between SCB and PCB
Original publication
Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis. JACC Cardiovasc Interv. Published 19 February 2025. doi:10.1016/j.jcin.2024.12.024
Summarised from the published abstract; every number is checked against it