Russian Federation: Study on Hybrid Operations for Iliofemoral Peripheral Arterial Disease

The findings of a new study conducted by Vladimir Starodubtsev and the team suggest the long-term safety and effectiveness of hybrid operations for individuals with iliofemoral peripheral arterial disease. The complete data of this study were published in the European Journal of Vascular and Endovascular Surgery.

Vascular surgeons face a dilemma when treating patients with combined iliac as well as common femoral artery (CFA) occlusive disease. Open surgical reconstruction (OR) or hybrid repair (HR) combining iliac stenting and femoral endarterectomy are the current recommendations. As a result, the goal of this randomized controlled study was to examine the short and midterm safety and effectiveness of hybrid repair and Open surgical reconstruction procedures for individuals with the co-existing iliac and common femoral occlusive disease.

The study was entered into the ClinicalTrials.gov database. Between 2015 and 2017, eligible patients with combined iliac and CFA occlusive disease were randomly assigned to either HR or OR. HR group patients had iliac artery recanalization and stenting, as well as CFA endarterectomy and patch angioplasty. The OR group received aortofemoral bypass surgery with concurrent CFA endarterectomy. Short-term (30-day) and mid-term (36-month) outcomes were compared across groups, including mortality, morbidity, and patency rates.

Key Findings

• 202 of the 427 patients evaluated were randomly assigned.
• The HR group had a shorter average hospital stay; the 30-day perioperative morbidity rate was 8.8% vs. 21% in the OR group.
• The 36-month death rate did not change significantly.
• At 12 months, the cumulative primary patency rate was 93% (HR) vs. 93% (OR), and at 36 months, the cumulative primary patency rate was 91% (HR) vs. 89% (OR).
• At 12 months, the limb salvage rate was 99% (HR) vs. 99% (OR), and at 36 months, the rate was 98% (HR) vs. 97% (OR).

In conclusion, the findings of this first non-inferiority randomized research back up the safety and long-term effectiveness of hybrid operations for patients with iliofemoral peripheral artery disease. HR patients had lower perioperative morbidity and equivalent long-term patency rates.

Reference

Starodubtsev, V., Mitrofanov, V., Ignatenko, P., Gostev, A., Preece, R., Rabtsun, A., Saaya, S., Popova, I., & Karpenko, A. (2022). Editor's Choice – Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial. In European Journal of Vascular and Endovascular Surgery (Vol. 63, Issue 4, pp. 557–565). Elsevier BV. https://doi.org/10.1016/j.ejvs.2022.02.002