National Medical Research Centre, Ministry for Public Health Care of Russian Federation, Novosibirsk, Russian Federation.
National Medical Research Centre, Ministry for Public Health Care of Russian Federation, Novosibirsk, Russian Federation.
Eur J Vasc Endovasc Surg. 2022 Apr;63(4):557-565. doi: 10.1016/j.ejvs.2022.02.002. Epub 2022 Feb 9.
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.
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.
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).
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.
本非劣效随机试验旨在比较杂交修复（HR）和开放重建（OR）治疗合并髂股动脉（CFA）闭塞性疾病患者的短期和中期安全性和疗效。
该研究在 ClinicalTrials.gov 注册（标识符：NCT02580084）。2015 年至 2017 年，符合条件的合并髂股动脉闭塞性疾病的患者被随机分配至 HR 或 OR 组。HR 组患者接受髂动脉再通和支架置入术联合 CFA 内膜切除术和补片血管成形术。OR 组接受腹主动脉-股动脉旁路移植术，同时行 CFA 内膜切除术。比较两组患者的短期（30 天）和中期（36 个月）结局，包括发病率、死亡率和通畅率。
在 427 例评估患者中，202 例患者被随机分配（HR 组 102 例，OR 组 100 例）。HR 组患者的平均住院时间较短（8.2±4.2 天 HR 组 vs. 15.7±6.9 天 OR 组，p<.001）；HR 组患者 30 天围手术期发病率为 8.8%，OR 组为 21%（p=.030）。两组患者 36 个月死亡率无显著差异（p=.16）。12 个月时累积原发性通畅率分别为 HR 组 93%（HR）和 OR 组 93%（OR），36 个月时分别为 HR 组 91%（HR）和 OR 组 89%（OR）（p=.38）。12 个月时，肢体挽救率分别为 HR 组 99%（HR）和 OR 组 99%（OR），36 个月时分别为 HR 组 98%（HR）和 OR 组 97%（OR）（p=.49）。
这是第一项非劣效性随机研究的结果，支持杂交手术治疗髂股周围动脉疾病患者的安全性和中期疗效。HR 组患者的住院时间更短，围手术期发病率更低，中期通畅率相似。
