Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis: The SIBLINT-ISR Randomized Trial
Primary result · In-segment LLLResult — go to the resultDifference 0.07 mm 95% CI −0.05 to 0.19Authors' 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 patients285 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
Methodological detailsprospective, assessor-blinded, non-inferiority, 1:1 randomisation, 16 sites
- Prospective
- Assessor-blinded
- Non-inferiority
- 1:1 randomisation
- 16 sites
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
SCBvs PCB
difference 0.07 mm (95% CI −0.05 to 0.19); P for non-inferiority < 0.0001
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: The SIBLINT-ISR Randomized Trial. JACC Cardiovasc Interv. Published 19 February 2025. doi:10.
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