Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery

治疗外周动脉硬化性闭塞症(PAOD)的患者数量正在增加。大约50%的PAOD患者患有间歇性跛行(IC)，通常是由股浅动脉(SFA)的动脉粥样硬化病变引起的。较短的狭窄或闭塞(&lt；10厘米)大多通过带支架或不带支架的经皮血管成形术(PTA)治疗，而病变很长(&gt；20厘米)的患者通常需要手术治疗。对于长度为10-20厘米的病变，最佳的血管重建方式广泛地基于个人喜好和机构的政策，而不是证据。这可能会导致血管内或外科手术的无效使用，结果不令人满意，社区成本高昂。ABC试验是一项前瞻性、随机、多中心试验，旨在比较血管内治疗(支架支持的血管成形术)和膝上股静脉转流术(优先采用自体静脉)对长度为10-20 cm的动脉粥样硬化性SFA病变引起的IC患者的最佳治疗效果。试验的主要终点将是“通过跑步机测试(3.2公里/小时，12%倾斜)，在24个月内无需重复靶病变血运重建(TLR)的情况下&gt；1级(卢瑟福分级)的临床改善”。根据文献的数据，我们预计终点差异为15%，支持手术。330例患者将被分析以证明其优越性(显著性水平5%，80%有效)。次要终点包括临床、血流动力学和形态标准、经济成本和生活质量。术前、术中和术后的血管造影术将由独立的放射学核心实验室进行评估。

The number of patients treated for peripheral arteriosclerotic occlusive disease (PAOD) is increasing. Approximately 50% of PAOD-patients suffer from Intermittent claudication (IC) caused very often by atherosclerotic lesions of the superficial femoral artery (SFA). Short stenoses or occlusions (<10 cm) are mostly treated by percutaneous transluminal angioplasty (PTA) with or without stenting whereas patients with very long lesions (>20 cm) are usually treated surgically. The optimal revascularising modality for lesions with a length of 10-20 cm is widely based on personal preferences and an institution’s policy rather than on evidence. This may lead to an ineffective usage of either endovascular or surgical procedures with unsatisfactory outcomes and high costs for the community. The ABC-trial is a prospective randomized multi-centre-trial to compare best endovascular treatment (stent-supported angioplasty) and above knee femoropopliteal bypass (preferentially with autologous vein) for patients suffering from IC caused by atherosclerotic SFA-lesions with a length of 10-20cm. The primary endpoint of the trial will be “the clinical improvement of >1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR) within 24 months as assessed by treadmill testing (3.2 km/h, 12% incline)”. Based on data from the literature we expect an endpoint-difference of 15% in favour of the surgery. 330 patients will be analysed to prove superiority (significance level 5%, 80% power). Secondary endpoints include clinical, hemodynamic and morphological criteria, economic costs and quality of life. Pre-, intra- and postprocedural angiograms will be evaluated by an independent radiological core lab.