Saaya Shoraan, Akulov Vsevolod, Gostev Alexander, Cheban Aleksey, Osipova Olesya, Ignatenko Pavel, Starodubtsev Vladimir, Gouëffic Yann, Karpenko Andrey, Chernyavskiy A M
Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.
Laboratoire De Physiopathologie De La Résorption Osseuse, Nantes, France.
Catheter Cardiovasc Interv. 2025 Aug;106(2):1098-1106. doi: 10.1002/ccd.31649. Epub 2025 Jun 2.
The treatment of patients with a simultaneous lesion of the iliac and common femoral arteries presents a significant challenge.
The objective of pilot randomized trial (ClinicalTrials.gov) was to compare the short and 3-year safety and efficacy of endovascular treatment (EVT) and hybrid repair (HR) procedures with using an interwoven nitinol stent for patients with coexisting iliac and common femoral occlusive disease.
In the EVT group patients after recanalization and balloon angioplasty iliac and common femoral arteries were treated with interwoven nitinol stents. In the HR group, patients underwent recanalization and stenting of iliac arteries as in the EVT group but endarterectomy and patch angioplasty for the common femoral artery. Perioperative 1, 2, and 3-year outcomes were compared between both groups.
Totally 62 patients were randomized (31 EVT and 31 HR). The average hospital length of stay was shorter in EVT group (3.9 ± 1.2 days EVT group vs. 7.9 ± 2.7 days HR group, p = 0.001). There were no mortalities, no MACEs in either group within 30 days post-op. Thirty-day perioperative morbidity rate was 9.7% in EVT group versus 22.6% in HR group (p = 0.17). The primary patency rate at 12, 24 and 36 months was 81%, 60%, and 46% in the EVT group, 94%, 80%, and 73% in the HR group (p = 0.12, p = 0.09, and p = 0.03). The secondary patency rates at 36 months in EVT group was 83% versus 87% in HR group, respectively (p = 0.64). Survival and limb salvage rates did not differ between groups at 36 months of follow-up (93% vs. 93% p = 0.97% and 97% vs. 100% p = 0.31 respectively).
This study supports that the hybrid treatment has an advantage over EVT in terms of safety and primary patency in the mid-term follow-up period. However, a larger study is needed to confirm these findings and further investigate the long-term effects of the hybrid approach.
同时患有髂动脉和股总动脉病变的患者的治疗面临重大挑战。
一项初步随机试验（ClinicalTrials.gov）的目的是比较血管内治疗（EVT）和杂交修复（HR）手术使用编织镍钛诺支架治疗并存的髂动脉和股总动脉闭塞性疾病患者的短期和3年安全性及有效性。
在EVT组中，髂动脉和股总动脉再通及球囊血管成形术后的患者用编织镍钛诺支架治疗。在HR组中，患者如EVT组一样接受髂动脉再通和支架置入，但股总动脉行内膜切除术和补片血管成形术。比较两组围手术期1年、2年和3年的结果。
共62例患者被随机分组（31例EVT组和31例HR组）。EVT组平均住院时间较短（EVT组3.9±1.2天 vs. HR组7.9±2.7天，p = 0.001）。术后30天内两组均无死亡病例，无重大不良心血管事件。EVT组围手术期30天发病率为9.7%，HR组为22.6%（p = 0.17）。EVT组12个月、24个月和36个月的主要通畅率分别为81%、60%和46%，HR组分别为94%、80%和73%（p = 0.12、p = 0.09和p = 0.03）。EVT组36个月时的次要通畅率为83%，HR组为87%（p = 0.64）。随访36个月时两组的生存率和肢体挽救率无差异（分别为93% vs. 93%，p = 0.97%和97% vs. 100%，p = 0.31）。
本研究支持在中期随访期内，杂交治疗在安全性和主要通畅率方面优于EVT。然而，需要更大规模的研究来证实这些发现并进一步研究杂交治疗方法的长期效果。
