Gouëffic Yann, Kaladji Adrien, Guyomarch Béatrice, Montagne Carine, Fairier Damien, Gestin Simon, Riche Valéry-Pierre, Vent Pierre Alexandre, Chaillou Philippe, Costargent Alain, Patra Philippe
CHU Nantes, l'institut du thorax, service de chirurgie vasculaire, Nantes F-44000, France.
Trials. 2014 Oct 30;15:423. doi: 10.1186/1745-6215-15-423.
Currently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15 cm. However, the Achilles' heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14 cm).
METHODS/DESIGN: A prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14 cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1 year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease.
This is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length.
Clinicaltrials.gov identifier: NCT02004951. 3 December 2013.
目前，血管内治疗适用于治疗长度≤15 cm的股腘动脉病变。然而，股腘动脉血管内修复的致命弱点仍是再狭窄。与经皮腔内血管成形术相比，紫杉醇洗脱支架在预防股腘动脉病变再狭窄方面已显示出有前景的结果。一项最近发布的使用新一代自膨胀镍钛合金支架（Misago®；日本东京泰尔茂株式会社）的前瞻性注册研究支持将原发性裸金属支架置入作为股腘动脉病变的一线治疗方法。迄今为止，尚无研究设计用于比较裸金属支架与紫杉醇洗脱支架治疗股腘动脉病变的效果。BATTLE试验旨在比较紫杉醇洗脱支架（Zilver® PTX®）和上一代裸自膨胀镍钛合金支架（Misago® RX，日本东京泰尔茂株式会社）治疗中等长度股腘动脉病变（≤14 cm）的效果。
方法/设计：已设计一项前瞻性、随机（1:1）、对照、多中心国际研究。186例符合纳入标准的患者将被随机分配至两种血管内修复评估方法之一，以治疗有症状患者（卢瑟福分级2至5级）中长度≤14 cm的初发股腘动脉病变：裸支架组和紫杉醇洗脱支架组。主要终点是1年时支架内无再狭窄，定义为目标病变处收缩期峰值流速指数>2.4（再狭窄>50%），并通过双功超声扫描评估。我们的主要目的是证明在有症状的外周动脉疾病患者中，使用Zilver® PTX®支架系统进行原发性支架置入术相对于裸金属自膨胀支架置入术在治疗股腘动脉病变方面的临床优越性。
这是第一项比较裸金属支架和紫杉醇洗脱支架治疗股腘动脉病变疗效的随机对照研究。它可能会明确中等长度股腘动脉病变支架选择的适应证。
Clinicaltrials.gov标识符：NCT02004951。2013年12月3日。
