Editor's Choice - Hybrid vs. Open Surgical Reconstruction for Iliofemoral Occlusive Disease: A Prospective Randomised Trial
Vladimir Starodubtsev, Vacheslav Mitrofanov, Pavel Ignatenko, Alexander Gostev, Ryan Preece, Artem Rabtsun, Shoraan Saaya, Irina Popova, Andrey Karpenko, Vladimir Starodubtsev, Vacheslav Mitrofanov, Pavel Ignatenko, Alexander Gostev, Ryan Preece, Artem Rabtsun, Shoraan Saaya, Irina Popova, Andrey Karpenko
Abstract
Objective: The aim of this non-inferiority randomised trial was to compare the short and midterm safety and efficacy of hybrid repair (HR) and open reconstruction (OR) for patients with co-existing iliac and common femoral artery (CFA) occlusive disease.
Methods: The study was registered on the ClinicalTrials.gov register (identifier: NCT02580084). From 2015 to 2017, eligible patients presenting with combined iliac and CFA occlusive disease were randomised to either HR or OR. HR group patients underwent recanalisation and stenting of iliac arteries combined with CFA endarterectomy and patch angioplasty. The OR group underwent aortofemoral bypass with simultaneous CFA endarterectomy. Short (30 day) and midterm (36 month) outcomes including morbidity, mortality, and patency rates were compared between groups.
Results: Of 427 patients assessed, 202 were randomised (102 HR and 100 OR). The average hospital length of stay was shorter in the HR group (8.2 ± 4.2 days HR group vs. 15.7 ± 6.9 days OR group, p < .001); the 30 day peri-operative morbidity rate was 8.8% in the HR group vs. 21% in the OR group (p = .030). There was no significant difference in the 36 month mortality rate (p = .16). The cumulative primary patency rates were 93% (HR) vs. 93% (OR) at 12 months and 91% (HR) vs. 89% (OR) at 36 months (p = .38). The limb salvage rates were 99% (HR) vs. 99% (OR) at 12 months and 98% (HR) vs. 97% (OR) at 36 months (p = .49).
Conclusion: The results of this first non-inferiority randomised study support the safety and midterm efficacy of hybrid procedures for patients with iliofemoral peripheral arterial disease. HR patients had a shorter length of stay with reduced peri-operative morbidity and similar medium term patency rates.
Keywords: Aortofemoral; D lesions bypass; Hybrid surgery; Iliac occlusive disease; TASC II type C.
Copyright © 2022 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
Source: PubMed