Comparing the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: A Prospective Randomized Study (TIS 2 Study)
Primary result · In-segment late lumen lossResult — go to the resultΔlate lumen loss −0.024 mm 95% CI −0.277 to 0.229Authors' conclusion
The noninferiority of SEB relative to PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not confirmed.
Study context
- Population
- Patients with bare-metal stent or drug-eluting stent coronary in-stent restenosis (BMS-ISR or DES-ISR)patients with 158 BMS or DES-ISR lesions
- Participants
- 145 patients
- Comparison
- Sirolimus-eluting balloon (SEB) vs paclitaxel-eluting balloon (PEB) for the treatment of BMS-ISR or DES-ISR
Primary result
In-segment late lumen loss · 12 months
Δlate lumen loss
−0.024 mm
95% CI −0.277 to 0.229
SEBvs PEB
Δlate lumen loss −0.024 mm (95% CI −0.277 to 0.229)
As reported in the abstract
Further findings
Repeated binary ISR · 12 months · no significant difference
P = 0.906
Major adverse cardiac events (cardiac death, nonfatal acute myocardial infarction, or target lesion revascularization) · 12 months · no significant difference
P > 0.999
| Outcome | Δlate lumen loss (mm) (95% CI) | |
|---|---|---|
| In-segment late lumen loss, BMS-ISR group (post hoc subanalysis) · 12 monthsPost hoc subanalysis · post hoc | −0.203 (−0.584 to 0.178) | |
| −1−0.500.5Difference, mm (linear scale) |
Original publication
Comparing the Efficacy of Sirolimus and Paclitaxel-Eluting Balloon Catheters in the Treatment of Coronary In-Stent Restenosis: A Prospective Randomized Study (TIS 2 Study). Circ Cardiovasc Interv. Published 2 April 2025. doi:10.
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