Department of Interventional Radiology, Hospital Universitario Lozano Blesa, Zaragoza, Spain.
Division of Angiology, Medical University Graz, Graz, Austria.
J Vasc Interv Radiol. 2023 Oct;34(10):1707-1715.e7. doi: 10.1016/j.jvir.2023.06.041. Epub 2023 Jul 6.
To investigate the clinical performance and safety of the Passeo-18 Lux drug-coated balloon (DCB) in complex femoropopliteal Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions in an all-comers patient population.
Data from BIOLUX P-III SPAIN, a prospective, national, multicenter, postmarket all-comers registry conducted from 2017 to 2019, and a matching long lesion subgroup from the BIOLUX P-III All-Comers global registry conducted from 2014 to 2018 were pooled for analysis. The primary safety end point was freedom from major adverse events (MAEs) at 6 months, and the primary performance end point was freedom from clinically driven target lesion revascularization (fCD-TLR) at 12 months, both adjudicated by an independent clinical events committee.
A total of 159 patients, of whom 32.7% had critical limb ischemia, were included in the Passeo-18 Lux long lesion cohort. The mean lesion length was 248.5 mm ± 71.6, and the majority were occluded (54.1%), calcified (87.4%), and of type TASC C (49.1%) or TASC D (50.9%). Freedom from MAEs was 90.6% (95% CI, 84.6-94.3) at 6 months and 83.9% (95% CI, 76.7-89.0) at 12 months. fCD-TLR was 84.4% (95% CI, 77.3-89.5) at 12 months. Freedom from target limb major amputation was 98.6% (95% CI, 94.6-99.7), and all-cause mortality was 5.3% (95% CI, 2.7-10.4) at 12 months. There were no device- or procedure-related deaths or amputations up to the 12-month follow-up.
Passeo-18 Lux DCB is safe and effective for the treatment of long femoropopliteal lesions in a real-word setting.
研究在所有患者人群中，Passeo-18 Lux 药物涂层球囊（DCB）在复杂股腘 Trans-Atlantic Inter-Society Consensus（TASC）C 和 D 病变中的临床性能和安全性。
本研究对 2017 年至 2019 年期间进行的前瞻性、全国性、多中心、上市后所有患者注册登记 BIOLUX P-III SPAIN 的数据，以及对 2014 年至 2018 年进行的 BIOLUX P-III 所有患者全球注册登记中匹配的长病变亚组数据进行了汇总分析。主要安全性终点为 6 个月时无重大不良事件（MAE），主要性能终点为 12 个月时无临床驱动的靶病变血运重建（fCD-TLR），均由独立临床事件委员会裁定。
在 Passeo-18 Lux 长病变队列中，共纳入 159 例患者，其中 32.7%为严重肢体缺血患者。平均病变长度为 248.5mm±71.6mm，大多数病变为闭塞（54.1%）、钙化（87.4%）、TASC C 型（49.1%）或 TASC D 型（50.9%）。6 个月时 MAE 无发生率为 90.6%（95%CI，84.6-94.3），12 个月时为 83.9%（95%CI，76.7-89.0）。12 个月时 fCD-TLR 为 84.4%（95%CI，77.3-89.5）。靶肢体主要截肢率为 98.6%（95%CI，94.6-99.7），12 个月时全因死亡率为 5.3%（95%CI，2.7-10.4）。至 12 个月随访时，无与器械或手术相关的死亡或截肢。
在真实环境中，Passeo-18 Lux DCB 治疗股腘长病变是安全有效的。
