Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany.
Clinic Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
J Endovasc Ther. 2020 Apr;27(2):304-315. doi: 10.1177/1526602819898804. Epub 2020 Jan 28.
To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. BIOLUX P-III is an international, prospective, observational registry ( identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.
为了进一步研究在真实世界条件下，Passeo-18 Lux 药物涂层球囊（DCB）治疗动脉粥样硬化下肢疾病的安全性和性能。BIOLUX P-III 是一项国际性、前瞻性、观察性注册研究（标识符 NCT02276313），在欧洲、亚洲和澳大利亚的 41 个中心进行，随访时间为 6、12 和 24 个月。在所有患者队列的 700 名患者（平均年龄 70.0±10.2 岁；439 名男性）中，863 处病变中，330 名（47.1%）患者患有糖尿病，234 名（37.7%）患者患有慢性肢体威胁性缺血。大多数（79.3%）病变位于股腘段；所有病变中，645 处（74.9%）为钙化病变，99 处（11.5%）存在支架内再狭窄（ISR）。病变平均长度为 84.7±73.3mm。主要临床终点是 6 个月内的主要不良事件（MAEs），包括 30 天内与器械和手术相关的死亡率、主要靶肢体截肢和临床驱动的靶病变血运重建（TLR）。主要性能终点是 12 个月内的临床驱动 TLR。在 6 个月和 12 个月时，所有患者队列的 MAEs 无事件率分别为 94.0%和 89.5%：股腘段分别为 95.0%和 91.2%，ISR 亚组分别为 95.3%和 88.0%。所有患者队列 12 个月时的临床驱动 TLR 无事件率为 93.1%，股腘段病变为 93.9%，ISR 病变为 89.4%。所有原因死亡率为 6.1%，所有患者队列中：股腘段和 ISR 亚组均为 5.9%。在 12 个月内没有与器械或手术相关的死亡。12 个月时，超过 80%的所有亚组的 Rutherford 分类均有所改善。在真实世界的患者人群中，Passeo-18 Lux DCB 治疗动脉粥样硬化下肢病变的安全性和性能保持不变，12 个月时的治疗效果良好，并发症发生率低。
