Antonello M, Frigatti P, Battocchio P, Lepidi S, Dall'Antonia A, Deriu G P, Grego F
Vascular and Endovascular Section, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Padua, Italy.
J Cardiovasc Surg (Torino). 2007 Jun;48(3):267-74.
The aim of this prospective comparative study was to compare the results of 8-years experience of endovascular treatment (ET) of popliteal aneurysms (PAs) using the Hemobahn/Viabahn endograft with those achieved with open repair (OR). Endpoints were primary and secondary patency rate.
The study was a prospective randomized clinical trial from January 1999 to December 2003 and a prospective comparative study from January 2004 to December 2006. Patients with an asymptomatic aneurismal lesion in the popliteal artery 2 cm at angio-computed tomography were included in the study. Indication for ET was PA (proximal and distal neck length >1 cm); contraindications were: 1) age <50 years; 2) poor distal run-off; 3) contraindication to antiplatelet, anticoagulant or thrombolytic therapy.
Between January 1999 and December 2006, of a total of 42 patients with 48 PA, 27 were treated with OR (group A) and 21 with ET (group B). The primary patency rate was 100% in group A and 80.9% in group B at 12 months and 71.4% and 88.1%, respectively, at 72 months; the secondary patency rate at 72 months was 88.15% and 85.9% in groups A and B, respectively. No statistical differences were observed at the log-rank test. During the entire study period, 3 (14.3%) patients in group B required conversion to open surgery because of endograft occlusion.
Within the power limitations of this study, ET for asymptomatic PA in patients with suitable anatomy can be considered safe, with long-term results comparable with those of OR.
本前瞻性对比研究旨在比较使用Hemobahn/Viabahn血管内支架移植物对腘动脉瘤(PA)进行8年血管内治疗(ET)的结果与开放修复(OR)的结果。观察终点为一期通畅率和二期通畅率。
本研究于1999年1月至2003年12月为前瞻性随机临床试验,2004年1月至2006年12月为前瞻性对比研究。血管计算机断层扫描显示腘动脉有无症状动脉瘤性病变且病变长度在2 cm以内的患者纳入本研究。ET的指征为PA(近端和远端颈部长度>1 cm);禁忌证为:1)年龄<50岁;2)远端血流不佳;3)抗血小板、抗凝或溶栓治疗禁忌。
1999年1月至2006年12月,共有42例患者患有48个PA,其中27例接受OR治疗(A组),21例接受ET治疗(B组)。A组12个月时一期通畅率为100%,B组为80.9%;72个月时分别为71.4%和88.1%;A组和B组72个月时的二期通畅率分别为88.15%和85.9%。对数秩检验未观察到统计学差异。在整个研究期间,B组有3例(14.3%)患者因血管内支架移植物闭塞而需要转为开放手术。
在本研究的能力限制范围内,对于解剖结构合适的无症状PA患者,ET可被认为是安全的,其长期结果与OR相当。