DETOUR2 Trial Outcomes Demonstrate Clinical Utility of Percutaneous Transmural Bypass for the Treatment of Long-Segment, Complex Femoropopliteal Disease

医学 经皮 临床终点 外科 血运重建 试验装置豁免 不利影响 再狭窄 腘动脉 血栓形成 股动脉 靶病变 放射科 临床试验 心脏病学 随机对照试验 内科学 支架 经皮冠状动脉介入治疗 心肌梗塞
作者
Sean P. Lyden,Peter Soukas,Ajanta De,Barry Tedder,Jonathan Bowman,Jihad Mustapha,Ehrin J. Armstrong
出处
期刊:Journal of Vascular Surgery [Elsevier BV]
标识
DOI:10.1016/j.jvs.2024.02.004
摘要

Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals.The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year.We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures.The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.
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