Ott Ilka, Cassese Salvatore, Groha Philipp, Steppich Birgit, Voll Felix, Hadamitzky Martin, Ibrahim Tareq, Kufner Sebastian, Dewitz Karl, Wittmann Theresa, Kasel Albert Markus, Laugwitz Karl-Ludwig, Schunkert Heribert, Kastrati Adnan, Fusaro Massimiliano
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
J Am Heart Assoc. 2017 Jul 25;6(7):e006321. doi: 10.1161/JAHA.117.006321.
Paclitaxel-eluting balloon (PEB) angioplasty has superior efficacy compared with conventional balloon angioplasty (BA) for de novo lesions of superficial femoral artery (SFA). Studies investigating the angiographic and clinical performance of PEB angioplasty versus BA for in-stent restenosis of SFA are limited. We performed a randomized trial to investigate angiographic and clinical performance of PEB versus BA for in-stent restenosis of SFA.
Patients with symptomatic in-stent restenosis of SFA were randomly assigned to either PEB or BA at 2 centers in Munich, Germany. The primary end point was the percentage diameter stenosis at 6- to 8-month follow-up angiography. Secondary end points were the rate of binary restenosis at follow-up angiography and target lesion revascularization, target vessel thrombosis, ipsilateral amputation, bypass surgery of the affected limb, and all-cause mortality at 24-month follow-up. Seventy patients were assigned to PEB (n=36) or BA (n=34). Mean lesion length was 139±67 mm, and roughly one third of lesions were completely occluded at the time of the index procedure. At control angiography, the percentage diameter stenosis (44±33% versus 65±33%, =0.01) and binary restenosis were significantly reduced with PEB versus BA (30% versus 59%, =0.03). At 24-month follow-up, PEB was associated with a significant reduction of target lesion revascularization in comparison to BA (19% versus 50%, =0.007). There was no difference with respect to other outcomes of interest.
In patients with in-stent restenosis of SFA, a percutaneous therapy with PEB compared with BA has superior angiographic performance at 6 to 8 months and improved clinical efficacy up to 24-month follow-up.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01083394.
对于股浅动脉（SFA）的初发病变，紫杉醇洗脱球囊（PEB）血管成形术比传统球囊血管成形术（BA）具有更高的疗效。关于PEB血管成形术与BA治疗SFA支架内再狭窄的血管造影和临床疗效的研究有限。我们进行了一项随机试验，以研究PEB与BA治疗SFA支架内再狭窄的血管造影和临床疗效。
德国慕尼黑的2个中心将有症状的SFA支架内再狭窄患者随机分为PEB组或BA组。主要终点是6至8个月随访血管造影时的直径狭窄百分比。次要终点是随访血管造影时的二元再狭窄率、靶病变血运重建、靶血管血栓形成、同侧截肢、患肢搭桥手术以及24个月随访时的全因死亡率。70例患者被分配到PEB组（n = 36）或BA组（n = 34）。平均病变长度为139±67mm，约三分之一的病变在初次手术时完全闭塞。在对照血管造影中，与BA相比，PEB组的直径狭窄百分比（44±33% 对 65±33%，P = 0.01）和二元再狭窄率显著降低（30% 对 59%，P = 0.03）。在24个月随访时，与BA相比，PEB组的靶病变血运重建显著减少（19%对50%，P = 0.007）。在其他感兴趣的结局方面没有差异。
对于SFA支架内再狭窄患者，与BA相比，PEB经皮治疗在6至8个月时具有更好的血管造影表现，并且在长达24个月的随访中临床疗效更佳。
