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Randomized Controlled Trial
. 2025 Apr 28;18(8):963-971.
doi: 10.1016/j.jcin.2024.12.024. Epub 2025 Feb 19.

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

Haiwei Liu  1 , Yi Li  1 , Guosheng Fu  2 , Jian An  3 , Shaoliang Chen  4 , Zhixiong Zhong  5 , Bin Liu  6 , Chunguang Qiu  7 , Likun Ma  8 , Hongliang Cong  9 , Hui Li  10 , Qian Tong  11 , Ben He  12 , Zening Jin  13 , Jun Zhang  14 , Haitao Yuan  15 , Miaohan Qiu  1 , Ruiyan Zhang  16 , Yaling Han  17
Affiliations
Randomized Controlled Trial

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

Haiwei Liu et al. JACC Cardiovasc Interv. .

Abstract

Background: The use of drug-coated balloons is a well-established strategy for the management of coronary vessels. However, head-to-head comparisons of sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) for treating in-stent restenosis (ISR) are currently limited.

Objectives: The aim of this randomized, controlled trial (SIBLINT-ISR [Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis]) was to compare a novel SCB with a PCB for the treatment of ISR.

Methods: In this prospective, assessor-blinded, controlled trial, patients with eligible ISR lesions were randomized 1:1 to treatment with either an SCB (SeQuent SCB, B. Braun Melsungen; 4 μg/mm2) or a PCB (SeQuent Please NEO, B. Braun Melsungen; 3 μg/mm2). The primary endpoint was noninferiority for 9-month angiographic in-segment late lumen loss (LLL). The main secondary endpoints were procedural success, target lesion restenosis rate, and target lesion failure (cardiac death, target vessel myocardial infarction, or revascularization) at 12 months.

Results: A total of 258 patients with 285 lesions at 16 sites were randomly assigned to the SCB (n = 130) and PCB (n = 128) groups. At 9 months, the difference in the primary endpoint of in-segment LLL between the SCB group (0.37 ± 0.48 mm) and the PCB group (0.30 ± 0.38 mm) was 0.07 mm (95% CI: -0.05 to 0.19 mm), demonstrating noninferiority of the SCB to the PCB in terms of in-segment LLL, with a noninferiority margin of 0.20 mm (P for noninferiority < 0.0001). There were no significant differences in 12-month clinical outcomes between the SCB and PCB groups.

Conclusions: 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. (Sirolimus-Coated Balloon Versus Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis [SIBLINT ISR]; NCT04240444).

Keywords: drug-coated balloon; in-stent restenosis; paclitaxel; randomized controlled trial; sirolimus.

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Conflict of interest statement

Funding Support and Author Disclosures The SIBLINT-ISR study was funded by B. Braun Medical (Shanghai) International Trading Co. LTD. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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