Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis: The SIBLINT-ISR Randomized Trial.

Summary

In a 16-center, assessor-blinded randomized trial (n=258), a novel sirolimus-coated balloon was noninferior to a paclitaxel-coated balloon for coronary in-stent restenosis based on 9-month in-segment late lumen loss. Twelve-month clinical outcomes were similar between groups.

Key Findings

• Noninferiority achieved for 9-month in-segment late lumen loss: SCB 0.37 ± 0.48 mm vs PCB 0.30 ± 0.38 mm; difference 0.07 mm (95% CI −0.05 to 0.19), P for noninferiority < 0.0001.
• No significant differences in 12-month clinical outcomes between SCB and PCB.
• Multicenter (16 sites), assessor-blinded randomized design with 258 patients and 285 lesions.

Clinical Implications

Sirolimus-coated balloons can be considered an alternative to paclitaxel-coated balloons for ISR, with comparable angiographic efficacy and short-term clinical outcomes.

Limitations

• Sample size modest and powered for angiographic, not hard clinical endpoints
• Follow-up limited to 12 months for clinical outcomes

Future Directions

Longer-term follow-up and subgroup analyses (e.g., BMS vs DES ISR) to define durability and identify populations benefiting most from SCB.