背景:血管内治疗已成为大多数动脉区域的一线治疗。然而,开放血管手术(动脉内膜切除术)仍然是股总动脉(CFA)病变的首选治疗方法。这项研究的目的是研究定向斑块切除术加药物涂层球囊(DCB)与动脉内膜切除术治疗新生动脉硬化性CFA病变的急性和中期结果。
方法:这种前瞻性,随机化,多中心非劣效性研究将纳入306名患有CFA(卢瑟福1-5类)从头狭窄(包括分叉)的参与者。符合两个治疗组条件的患者可以包括在这个1:1随机试验中。主要疗效终点是在12个月时靶病变的通畅性,定义为再狭窄<50%,而不需要临床驱动的靶病变血运重建(cdTLR)。主要安全终点是包括死亡在内的联合终点,心肌梗塞,目标肢体的主要或次要截肢,和围手术期并发症在30天。次要终点包括6个月和24个月时靶病变的原发通畅,二级通畅,cdTLR6、12和24个月,踝臂指数改变,卢瑟福-贝克尔在6、12和24个月上课。肢体抢救,用步行障碍问卷衡量的生活质量变化,以及包括死亡在内的主要不良事件,心肌梗塞,目标肢体的轻微或严重截肢将在6、12、24和36个月时确定。
结论:CFA病变的血管内治疗仍存在争议。迄今为止,很少有研究将现代血管内治疗方法与所谓的金标准外科动脉内膜切除术进行比较。根据最近的积极结果,本研究旨在确认与外科治疗相比,“不留任何痕迹”的血管内途径联合定向斑块切除术和DCB的非劣效性.
背景:ClinicalTrials.govNCT02517827。
BACKGROUND: Endovascular therapy has become established as a first-line therapy in most arterial regions. However, open vascular surgery (endarterectomy) remains the treatment of choice for common femoral artery (CFA) lesions. The aim of this study is to investigate the acute and mid-term results of directional
atherectomy plus drug-coated balloon (DCB) in comparison to endarterectomy in treatment of de novo arteriosclerotic CFA lesions.
METHODS: This prospective, randomized, multicenter non-inferiority study will enroll 306 participants with symptomatic (Rutherford category 1 to 5) de novo stenosis of the CFA including the bifurcation. Patients eligible for both treatment groups could be included in this 1:1 randomized trial. Primary efficacy endpoint is patency of the target lesion at 12 months defined as restenosis < 50% without the need of clinically driven target lesion revascularization (cdTLR). Primary safety endpoint is a combined endpoint including death, myocardial infarction, major or minor amputation of the target limb, and peri-procedural complications at 30 days. Secondary endpoints include primary patency of the target lesion at 6 and 24 months, secondary patency, cdTLR 6, 12, and 24 months, change in ankle-brachial index, and Rutherford-Becker class at 6, 12, and 24 months. Limb salvage, change in quality of life measured by Walking Impairment Questionnaire, and major adverse events including death, myocardial infarction, and minor or major amputation of the target limb will be determined at 6, 12, 24, and 36 months.
CONCLUSIONS: Endovascular treatment of CFA lesions is still a matter of debate. Few studies compared modern endovascular therapy methods against the so-called gold standard surgical endarterectomy so far. Based on recent positive results, this study aims to confirm non-inferiority of a \"leaving nothing behind\" endovascular approach combining directional
atherectomy and DCB compared to surgical therapy.
BACKGROUND: ClinicalTrials.gov NCT02517827.