Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany.
Institut für Diagnostische Und Interventionelle Radiologie, RoMed Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany.
Cardiovasc Intervent Radiol. 2021 Feb;44(2):207-217. doi: 10.1007/s00270-020-02663-7. Epub 2020 Oct 20.
After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions.
BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months.
877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up.
The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313).
在小型随机试验结果令人鼓舞后，BIOLUX P-III 研究的目的是在真实世界环境下，进一步研究 Passeo-18 lx 药物涂层球囊在下肢动脉中的安全性和疗效。
BIOLUX P-III 是一项全球性前瞻性单臂研究，随访时间为 6、12 和 24 个月。主要安全性终点是 6 个月内无重大不良事件（MAE）。主要疗效终点是 12 个月内无临床驱动的靶病变血运重建（TLR）。
共纳入 877 例患者/1084 处病变。糖尿病患者占 47.7%，有 42.1%的患者为严重肢体缺血（CLI）。平均病变长度为 89.0mm，钙化病变占 76.1%，闭塞病变占 24.9%。24 个月时，全队列无 MAE 发生率为 83.1%；股腘动脉人群为 84.9%（592 例患者，691 处病变）；长病变组为 77.7%（187 例患者/192 处病变）；支架内再狭窄（ISR）亚组为 72.5%（103 例患者/116 处病变）。全队列 24 个月无临床驱动 TLR 发生率为 88.1%；股腘动脉人群为 88.9%；长病变组为 80.3%；ISR 组为 78.4%。全队列 24 个月全因死亡率为 12.0%，股腘动脉人群为 10.2%，长病变组为 14.8%，ISR 组为 12.0%。至 24 个月随访时，无器械相关或操作相关死亡事件。
BIOLUX P-III 研究 24 个月的结果证实了 Passeo-18 lx 在下肢动脉中的安全性和疗效，在真实世界环境下，该药物在较大人群中使用，并发症发生率低，临床结局良好（NCT02276313）。
