[Short- and medium-term results of open and endovascular treatment of steno-occlusive lesions of the iliac segment (TASC II C, D) in a randomized clinical trial].

Background: Endovascular treatment of iliac occlusive lesions (TASC II C, D) is an alternative method of open surgical reconstruction which is the 'gold standard'. However, currently there are only few randomized trials comparing both treatment modalities, with a number of remaining issues especially concerning therapeutic policy depending on morphology of damage of target arteries.

Objective: The purpose of this randomized trial was to compare the short- and mid-term outcomes of endovascular and open surgical treatment in patients with lesions of the iliac segment (TASC II C, D) by criteria of safety and efficacy.

Patients and methods: This randomized trial was approved by the Local Ethics Committee of the 'National Medical Research Center named after Academician E.N. Meshalkin' of the Ministry of Health of the Russian Federation,and registered in the ClinicalTrials.gov register (identifier: NCT02209350). From June 2014 to March 2020, we treated a total of 202 patients with occlusive lesions of the iliac segment (TASC II C, D). Group 1 patients (n=101) underwent endovascular recanalization of iliac arteries and Group 2 patients (n=101) endured open reconstructions, i. e., aortofemoral bypass (AFB). All patients prior to surgery underwent duplex scanning of lower-limb arteries, ankle-brachial index (ABI) testing and multidetector computed tomographic angiography. The postoperative follow-up visits at 1, 6, 12 and 24 months consisted of physical examination, ABI measurement and duplex scanning or of the aortofemoral graft or stented iliac segment.

Results: The average hospital length of stay in the stenting group was 6.1±4.2 days vs 14.1±6.9 days in the AFB group (p<0.001). The technical success in the stenting group and ABI group patients amounted to 97% and 100%, respectively. The 30-day perioperative morbidity rate was 5% in the stenting group vs 17% in the AFB group (p=0.01). The cumulative primary patency rates at 24 months was 82% in the stenting group and 94% in the AFB group (p=0.01). Secondary and assisted primary patency rates at 24 months were 97% and 96% in the stenting group and 99% and 98% in the AFB group, respectively (p=0.32 and p=0.33). The limb salvage rate was 97% (stenting group) vs 98% (AFB group) at 24 months (p=0.64). The 2-year survival rate was 98% in the stenting group versus 94% in the AFB group (р=0.15).

Conclusion: Endovascular interventions in patients with stenotic-occlusive lesions of the iliac segment (TASC II C, D) were associated with a significantly lower rate of nosocomial systemic complications and significantly shorter hospital length of stay, however, by efficacy, endovascular revascularizations turned out to be significantly inferior to open surgery during the mentioned follow-up period.