Abstract：
BACKGROUND: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising.
OBJECTIVE: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population.
METHODS: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data.
RESULTS: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13).
CONCLUSIONS: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.
OBJECTIVE: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population.
METHODS: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data.
RESULTS: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13).
CONCLUSIONS: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.
摘要：
背景：西罗莫司涂层球囊（SCB）用于治疗股pop（FP）病变尚未得到系统研究，但早期研究的初步结果是有希望的.
目的：作者试图评估SELUTIONSLRSCB的安全性和有效性，由专有的微储层技术结合西罗莫司和生物可降解聚合物组成，当用于治疗日本人群的轻度至中度FP疾病时。
方法：这个多中心，prospective,单臂研究(SELUTIONSFAJAPAN)纳入134例FP病患者。由成像核心实验室和临床事件委员会独立裁定。主要终点是12个月的主要通畅，通过双工超声定义为收缩期峰值速度比≥2.5，并根据已建立的血管成形术数据与预定的60％的性能目标进行比较。
结果：平均年龄为73.8±6.9岁，60.3%的患者患有糖尿病。平均病变长度为127.4±59.7mm,17.2%为慢性完全闭塞,47.8％累及the动脉。127例患者（94.8%）获得了12个月再狭窄的数据。12个月的原发性通畅率为87.9％，根据Kaplan-Meier估计,临床驱动的靶病变血运重建(CD-TLR)的发生率为97.0%.主要不良事件发生率为6.7%,由4张CD-TLRs和5人死亡驱动，其中没有一个与设备或程序有关。踝臂指数数据从基线时的0.73±0.16显着改善至术后30天的0.96±0.14，并持续了12个月（0.94±0.13）。
结论：日本SELUTIONSFA试验表明，新型SELUTIONSCB是有症状的FP疾病患者的安全有效治疗选择。
目的：作者试图评估SELUTIONSLRSCB的安全性和有效性，由专有的微储层技术结合西罗莫司和生物可降解聚合物组成，当用于治疗日本人群的轻度至中度FP疾病时。
方法：这个多中心，prospective,单臂研究(SELUTIONSFAJAPAN)纳入134例FP病患者。由成像核心实验室和临床事件委员会独立裁定。主要终点是12个月的主要通畅，通过双工超声定义为收缩期峰值速度比≥2.5，并根据已建立的血管成形术数据与预定的60％的性能目标进行比较。
结果：平均年龄为73.8±6.9岁，60.3%的患者患有糖尿病。平均病变长度为127.4±59.7mm,17.2%为慢性完全闭塞,47.8％累及the动脉。127例患者（94.8%）获得了12个月再狭窄的数据。12个月的原发性通畅率为87.9％，根据Kaplan-Meier估计,临床驱动的靶病变血运重建(CD-TLR)的发生率为97.0%.主要不良事件发生率为6.7%,由4张CD-TLRs和5人死亡驱动，其中没有一个与设备或程序有关。踝臂指数数据从基线时的0.73±0.16显着改善至术后30天的0.96±0.14，并持续了12个月（0.94±0.13）。
结论：日本SELUTIONSFA试验表明，新型SELUTIONSCB是有症状的FP疾病患者的安全有效治疗选择。
