PDF(Pubmed)
Abstract：
BACKGROUND: The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice.
OBJECTIVE: The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB).
METHODS: This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients.
RESULTS: A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm2; p=non-significant.
CONCLUSIONS: This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).
OBJECTIVE: The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB).
METHODS: This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients.
RESULTS: A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm2; p=non-significant.
CONCLUSIONS: This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).
摘要：
背景：在目前的临床实践中，药物洗脱支架（DES）植入后支架内再狭窄（ISR）的治疗仍然具有挑战性。
目的：本研究旨在研究一种新型的Biolimus涂层球囊（BCB）治疗冠状动脉DES-ISR，与研究最好的紫杉醇涂层球囊（PCB）进行比较。
方法：这是一个前瞻性的，多中心,随机化，一种新型BCB与经临床证实的用于冠状动脉DES-ISR的PCB比较的非劣效性试验。主要终点是由独立核心实验室评估的9个月时的段内晚期管腔损失（LLL）。在预先指定的患者亚组中进行基线和随访光学相干断层扫描。
结果：共有来自17个中心的280名患者随机接受BCB（n=140）和PCB（n=140）治疗。9个月时,BCB组的LLL为0.23±0.37mm，而PCB组为0.25±0.35mm；两组之间的平均差异为-0.02（95％置信区间[CI]：-0.12至0.07）mm；非劣效性的p值<0.0001。两组在12个月时也观察到相似的临床结果。在光学相干层析成像子研究中，BCB组9个月时的新生内膜面积为2.32±1.04mm2,而PCB组为2.37±0.93mm2;两组间的平均差异为-0.09(95%CI:-0.94~0.76)mm2;p=无显著性.
结论：这种新型BCB的头对头比较显示，与临床证实的PCB相比，在冠状动脉DES-ISR治疗中的血管造影结果相似。（ClinicalTrials.gov：NCT04733443）。
目的：本研究旨在研究一种新型的Biolimus涂层球囊（BCB）治疗冠状动脉DES-ISR，与研究最好的紫杉醇涂层球囊（PCB）进行比较。
方法：这是一个前瞻性的，多中心,随机化，一种新型BCB与经临床证实的用于冠状动脉DES-ISR的PCB比较的非劣效性试验。主要终点是由独立核心实验室评估的9个月时的段内晚期管腔损失（LLL）。在预先指定的患者亚组中进行基线和随访光学相干断层扫描。
结果：共有来自17个中心的280名患者随机接受BCB（n=140）和PCB（n=140）治疗。9个月时,BCB组的LLL为0.23±0.37mm，而PCB组为0.25±0.35mm；两组之间的平均差异为-0.02（95％置信区间[CI]：-0.12至0.07）mm；非劣效性的p值<0.0001。两组在12个月时也观察到相似的临床结果。在光学相干层析成像子研究中，BCB组9个月时的新生内膜面积为2.32±1.04mm2,而PCB组为2.37±0.93mm2;两组间的平均差异为-0.09(95%CI:-0.94~0.76)mm2;p=无显著性.
结论：这种新型BCB的头对头比较显示，与临床证实的PCB相比，在冠状动脉DES-ISR治疗中的血管造影结果相似。（ClinicalTrials.gov：NCT04733443）。
