西罗莫司涂层球囊与紫杉醇涂层球囊治疗冠状动脉支架内再狭窄：SIBLINT-ISR随机试验
Sirolimus- vs Paclitaxel-Coated Balloon for the Treatment of Coronary In-Stent Restenosis: The SIBLINT-ISR Randomized Trial.
作者信息
Liu Haiwei, Li Yi, Fu Guosheng, An Jian, Chen Shaoliang, Zhong Zhixiong, Liu Bin, Qiu Chunguang, Ma Likun, Cong Hongliang, Li Hui, Tong Qian, He Ben, Jin Zening, Zhang Jun, Yuan Haitao, Qiu Miaohan, Zhang Ruiyan, Han Yaling
机构信息
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, People's Republic of China.
Sir Run Run Shaw Hospital, Hangzhou, People's Republic of China.
出版信息
JACC Cardiovasc Interv. 2025 Apr 28;18(8):963-971. doi: 10.1016/j.jcin.2024.12.024. Epub 2025 Feb 19.
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/mm) or a PCB (SeQuent Please NEO, B. Braun Melsungen; 3 μg/mm). 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).
背景
使用药物涂层球囊是治疗冠状动脉血管的一种成熟策略。然而，目前西罗莫司涂层球囊（SCB）和紫杉醇涂层球囊（PCB）治疗支架内再狭窄（ISR）的直接比较有限。
目的
本随机对照试验（SIBLINT-ISR [西罗莫司涂层球囊与紫杉醇涂层球囊治疗冠状动脉支架内再狭窄]）的目的是比较一种新型SCB与PCB治疗ISR的效果。
方法
在这项前瞻性、评估者盲法、对照试验中，符合条件的ISR病变患者按1:1随机分配接受SCB（SeQuent SCB，贝朗医疗；4μg/mm）或PCB（SeQuent Please NEO，贝朗医疗；3μg/mm）治疗。主要终点是9个月时血管造影节段内晚期管腔丢失（LLL）的非劣效性。主要次要终点是12个月时的手术成功率、靶病变再狭窄率和靶病变失败（心源性死亡、靶血管心肌梗死或血运重建）。
结果
16个中心的258例患者共285处病变被随机分配到SCB组（n = 130）和PCB组（n = 128）。9个月时，SCB组（0.37±0.48mm）和PCB组（0.30±0.38mm）节段内LLL主要终点的差异为0.07mm（95%CI：-0.05至0.19mm），表明SCB在节段内LLL方面不劣于PCB，非劣效界值为0.20mm（非劣效性P < 0.0001）。SCB组和PCB组12个月的临床结局无显著差异。
结论
在本研究中，发现一种新型SCB在治疗ISR患者时，9个月时节段内LLL方面不劣于PCB。（西罗莫司涂层球囊与紫杉醇涂层球囊治疗冠状动脉支架内再狭窄[SIBLINT ISR]；NCT04240444）
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