Legflow 药物涂层球囊治疗股腘动脉闭塞症的一年临床结果登记研究。
One-Year Clinical Outcomes of the Legflow Drug-Coated Balloon for the Treatment of Femoropopliteal Occlusions Registry.
机构信息
1 Department of Advanced Biomedical Sciences, University Federico II, Naples, Italy.
2 Vascular Surgery Clinic, UMBAL Sv. Georgi EAD, Plovdiv, Bulgaria.
出版信息
J Endovasc Ther. 2019 Feb;26(1):26-30. doi: 10.1177/1526602818823557.
PURPOSE
To report the 1-year outcomes of the prospective Legflow drug-coated balloon (DCB) registry, which evaluated the safety and 12-month efficacy of the Legflow balloon in the treatment of femoropopliteal disease.
METHODS
The Legflow is a new generation of DCB that has a homogenous, stable surface coating incorporating 0.1-µm paclitaxel particles. From January 2014 to June 2016, 139 patients (mean age 67.1±10.8 years; 109 men) were enrolled at 4 European institutions. Seventy-nine (56.8%) patients had claudication, while 60 (43.2%) had critical limb ischemia (CLI). Mean lesion length (MLL) was 90.0±41.2 mm. Eighty (57.6%) patients were treated for de novo lesions (MLL 83.2±41.2 mm), 29 (20.9%) for postangioplasty restenosis (MLL 81.2±30.9 mm), and 30 (21.6%) for in-stent restenosis (MLL 117.0±39.5 mm). The primary outcome measure was freedom from binary restenosis as determined by a peak systolic velocity ratio ≥2.4 on duplex or >50% stenosis on digital subtraction angiography at 12 months. The secondary outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.
RESULTS
Technical success was achieved in all the 139 treated patients. During the hospital stay, 3 CLI patients died of wound-related complications and 3 CLI patients underwent urgent TLR due to early occlusion in 2 and stent thrombosis in 1. At 12 months, 4 additional patients died of cardiac disease unrelated to the procedure. Of the 132 patients available for 1-year follow-up, the primary outcome (freedom from restenosis) was obtained in 107 (81.1%) patients. Freedom from CD-TLR was obtained in 110 (83.3%). Of the 25 late restenoses >50%, only 3 asymptomatic patients did not require TLR. Freedom from CD-TLR was higher in claudicants (87.0%) than in CLI patients (78.2%, p=0.20). In patients treated for in-stent restenosis, freedom from TLR at 1 year was 89.2%.
CONCLUSION
These data suggest that the use of a new generation paclitaxel-coated balloon represents a safe and effective therapeutic strategy for femoropopliteal obstructions in different clinical and anatomical settings. These data will need to be confirmed with longer-term follow-up and in randomized controlled trials.
目的
报告前瞻性 Legflow 药物涂层球囊（DCB）注册研究的 1 年结果，该研究评估了 Legflow 球囊在治疗股腘疾病中的安全性和 12 个月疗效。
方法
Legflow 是一种新一代的 DCB，其表面涂层具有均匀、稳定的特性，含有 0.1-µm 的紫杉醇颗粒。2014 年 1 月至 2016 年 6 月，4 家欧洲机构共纳入 139 例患者（平均年龄 67.1±10.8 岁；109 例男性）。79 例（56.8%）患者有间歇性跛行，60 例（43.2%）有严重肢体缺血（CLI）。平均病变长度（MLL）为 90.0±41.2mm。80 例（57.6%）患者为新发病变（MLL 83.2±41.2mm），29 例（20.9%）为经皮腔内血管成形术后再狭窄（MLL 81.2±30.9mm），30 例（21.6%）为支架内再狭窄（MLL 117.0±39.5mm）。主要终点是 12 个月时双功能超声检查显示峰值收缩速度比≥2.4 或数字减影血管造影显示狭窄≥50%，无二元再狭窄。次要终点是 12 个月时无临床驱动的靶病变血运重建（CD-TLR）。
结果
所有接受治疗的 139 例患者均达到技术成功。住院期间，3 例 CLI 患者因伤口相关并发症死亡，3 例 CLI 患者因 2 例早期闭塞和 1 例支架血栓形成而紧急进行 TLR。12 个月时，另外 4 例患者因与手术无关的心脏疾病死亡。在 132 例可进行 1 年随访的患者中，107 例（81.1%）患者达到主要终点（无再狭窄）。110 例（83.3%）患者达到 CD-TLR 无再狭窄。25 例晚期再狭窄>50%的患者中，只有 3 例无症状患者无需 TLR。CLI 患者的 CD-TLR 无再狭窄率（78.2%）低于间歇性跛行患者（87.0%，p=0.20）。在因支架内再狭窄而接受治疗的患者中，1 年 TLR 无再狭窄率为 89.2%。
结论
这些数据表明，使用新一代紫杉醇涂层球囊在不同的临床和解剖环境下代表了一种安全有效的股腘阻塞治疗策略。这些数据需要通过更长时间的随访和随机对照试验来证实。
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