Krievins Dainis K, Halena Grzegorz, Scheinert Dierk, Savlovskis Janis, Szopiński Piotr, Krämer Albrecht, Ouriel Kenneth, Nair Kasthuri, Holden Andrew, Schmidt Andrej
division/department, P. Stradins Clinical University Hospital, Department of Vascular Surgery, University of Latvia, Riga, Latvia.
division/department, Medical University of Gdansk, Division of Vascular Surgery, Department of Cardiac and Vascular Surgery, Gdansk, Poland.
J Vasc Surg. 2020 Nov;72(5):1648-1658.e2. doi: 10.1016/j.jvs.2020.02.043. Epub 2020 Apr 8.
The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease.
This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions >100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis ≥50%, occlusion, or CD-TVR.
During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length was 371 ± 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively. The ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P < .001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively. At 1 year, the Rutherford class improved in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%) through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism.
The 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions.
本研究旨在评估PQ旁路DETOUR系统（PQ Bypass，位于加利福尼亚州米尔皮塔斯）用于长段股腘动脉闭塞性疾病经皮旁路手术的1年安全性和有效性结果。
这项前瞻性、单臂、多中心试验纳入了患有长段股腘动脉疾病的患者。DETOUR系统通过经静脉途径经皮部署模块化支架移植物以绕过股腘病变。符合条件的患者包括患有跨大西洋两岸社会共识（TASC）C型和D型病变且长度>100毫米的患者。主要安全终点是1个月时的主要不良事件（MAE）发生率，定义为死亡、临床驱动的靶血管再血管化（CD-TVR）或大截肢的复合事件。主要有效性终点是6个月时支架移植物通畅率，定义为无≥50%狭窄、闭塞或CD-TVR。
在24个月期间，共纳入78例患者（82条肢体）。核心实验室测量的平均病变长度为371±55毫米；82处病变中的79处（96%）为慢性完全闭塞，82处病变中的55处（67%）有严重钙化。在初次手术期间测量的技术成功率和手术成功率均为96%，82条肢体中的79条在设备输送和部署过程中令人满意且无MAE。至1个月时，无死亡或截肢病例；81条肢体中有2条（3%）发生CD-TVR，无MAE的比例为98%（79/81）。1年时的Kaplan-Meier主要通畅率、辅助主要通畅率和次要通畅率分别为81%±4%、82%±4%和90%±3%。踝肱指数在基线和1年之间平均增加0.25±0.27（P<.001）。至1年时，支架移植物无血栓形成、无CD-TVR和无MAE的Kaplan-Meier估计值分别为84%±4%、85%±4%和84%±4%。1年时，80条肢体中的77条（96%）的卢瑟福分级得到改善，80条中的65条（81%）无症状。至1年时，79条靶肢体中有2条（3%）发生深静脉血栓形成，均发生在股腘静脉水平。无肺栓塞病例。
DETOUR I试验的1年结果表明，PQ旁路DETOUR系统对于患有较长、严重钙化的膝上股腘病变的患者是一种安全有效的经皮治疗选择。
