Abstract：
BACKGROUND: The effectiveness of excimer laser atherectomy (ELA) combined with drug-coated balloon (DCB) for de novo femoropopliteal artery disease (FPAD) is currently unknown. This case series evaluated the clinical outcomes of ELA combined with DCB in de novo FPAD from a real-world clinical perspective.
METHODS: We conducted a retrospective study of patients treated with ELA + DCB for de novo FPAD between November 2016 and January 2020. The primary efficacy endpoint was the initial patency rate; secondary endpoints included target lesion revascularization without clinically driven target lesion revascularization (CD-TLR) and technical success. Primary safety endpoints included all-cause death, unplanned major amputation, and postoperative complications.
RESULTS: The mean follow-up was 37.8 ± 25.3 months and included 56 consecutive patients (68.23 ± 8.01 years, 41 men). Forty-three patients had lifestyle-restricted claudication, and 13 patients had critical limb-threatening ischemia. The mean length of the lesion was 178.41 mm in all patients. The total lesion occlusion rate was 48.2 (n = 27), and the overall technical success rate was 100%. The 12-month, 24-month, 36-month, and 48-month primary patency rates of the ELA + DCB group were 75%, 66.1%, 58.9%, and 42.8%, respectively. Freedom from CD-TLR at 12, 24, 36, and 48 months was 83.9%, 80.3%, 76.8%, and 57.1%, respectively.
CONCLUSIONS: In real-world clinical practice, ELA + DCB appears to be a safe and effective endovascular treatment for de novo FPAD, with a low rate of freedom from CD-TLR and a good patency rate.
METHODS: We conducted a retrospective study of patients treated with ELA + DCB for de novo FPAD between November 2016 and January 2020. The primary efficacy endpoint was the initial patency rate; secondary endpoints included target lesion revascularization without clinically driven target lesion revascularization (CD-TLR) and technical success. Primary safety endpoints included all-cause death, unplanned major amputation, and postoperative complications.
RESULTS: The mean follow-up was 37.8 ± 25.3 months and included 56 consecutive patients (68.23 ± 8.01 years, 41 men). Forty-three patients had lifestyle-restricted claudication, and 13 patients had critical limb-threatening ischemia. The mean length of the lesion was 178.41 mm in all patients. The total lesion occlusion rate was 48.2 (n = 27), and the overall technical success rate was 100%. The 12-month, 24-month, 36-month, and 48-month primary patency rates of the ELA + DCB group were 75%, 66.1%, 58.9%, and 42.8%, respectively. Freedom from CD-TLR at 12, 24, 36, and 48 months was 83.9%, 80.3%, 76.8%, and 57.1%, respectively.
CONCLUSIONS: In real-world clinical practice, ELA + DCB appears to be a safe and effective endovascular treatment for de novo FPAD, with a low rate of freedom from CD-TLR and a good patency rate.
摘要：
目的：目前尚不清楚准分子激光旋切术（ELA）联合药物涂层球囊（DCB）治疗新发股pop动脉疾病（FPAD）的有效性。该病例系列从现实世界的临床角度评估了ELA联合DCB在从头FPAD中的临床结果。
方法：我们在2016年11月至2020年1月期间对接受ELA+DCB治疗的患者进行了回顾性研究。主要疗效终点是初始通畅率，次要终点包括没有临床驱动的靶病变血运重建(CD-TLR)的靶病变血运重建和技术成功.主要安全终点包括全因死亡,意外截肢,术后并发症。
结果：平均随访37.8±25.3个月，包括56例连续患者（68.23±8.01年，41名男子）。43例患者有生活方式限制的跛行，13例患者有严重的威胁肢体缺血。所有患者的平均病变长度为178.41mm。总病灶闭塞率为48.2(n=27),总体技术成功率为100%。12个月,24个月,ELA+DCB组的36个月和48个月的主要通畅率为75％，66.1%,58.9%和42.8%,分别。在12、24、36和48个月时，CD-TLR的自由度为83.9%，80.3%,76.8%和57.1%,分别。
结论：在现实世界的临床实践中，ELA+DCB似乎是一种安全有效的血管内治疗从头FPAD，CD-TLR的游离率低，通畅率良好。
方法：我们在2016年11月至2020年1月期间对接受ELA+DCB治疗的患者进行了回顾性研究。主要疗效终点是初始通畅率，次要终点包括没有临床驱动的靶病变血运重建(CD-TLR)的靶病变血运重建和技术成功.主要安全终点包括全因死亡,意外截肢,术后并发症。
结果：平均随访37.8±25.3个月，包括56例连续患者（68.23±8.01年，41名男子）。43例患者有生活方式限制的跛行，13例患者有严重的威胁肢体缺血。所有患者的平均病变长度为178.41mm。总病灶闭塞率为48.2(n=27),总体技术成功率为100%。12个月,24个月,ELA+DCB组的36个月和48个月的主要通畅率为75％，66.1%,58.9%和42.8%,分别。在12、24、36和48个月时，CD-TLR的自由度为83.9%，80.3%,76.8%和57.1%,分别。
结论：在现实世界的临床实践中，ELA+DCB似乎是一种安全有效的血管内治疗从头FPAD，CD-TLR的游离率低，通畅率良好。
