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Abstract

Objective: To compare the efficacy of a China-branded novel vein radiofrequency closure treatment system with an US-branded system in the treatment of primary lower extremity varicose veins.

Methods: This study was a single-center, prospective, non-inferiority randomized controlled trial. Patients with primary lower extremity varicose veins admitted to the Department of Vascular Surgery, the Fourth Affiliated Hospital of Zhejiang University School of Medicine, from January 2021 to January 2022, who met the inclusion and exclusion criteria, were included. Patients were randomly assigned in a 1:1 ratio to receive treatment with either the China-branded novel vein radiofrequency closure treatment system or the US-branded system. The technical success rate, system operability, incidence of adverse events and serious adverse events (SAEs) within 6 months postoperatively, and the target vein closure rate at 6 months postoperatively were compared between the two groups. Quantitative data were compared using the Mann-Whitney U test, and categorical data were compared using the χ2 test, Fisher's exact probability method, or non-inferiority test.

Results: A total of 80 patients were included in the study, with 41 patients in the experimental group with the China-branded system and 39 patients in the control group with the US-branded system. Among them, there were 27 males and 53 females, with an age of [M (IQR)] 55 (23) years (range 40 to 78 years old). There were 48 cases of left lower limb and 32 cases of right lower limb. The technical success rate and system control performance between the groups were 100%.T he incidence of adverse events (58.5% (24/41) vs. 61.5% (24/39), χ 2=0.075, P=0.784), and the incidence of SAE (7.3% (3/41) vs. 5.1% (2/39), χ 2=0.163, P=0.686) within 6 months after surgery in experimental group and control group had no statistical significance. There was one device-related adverse event in each of the two groups. In the experimental group, one patient developed endovenous heat-induced thrombosis after surgery and recovered after taking rivaroxaban tablets. One patient in the control group had pain in the upper right thigh for more than 1 day after operation, which was cured after using analgesic cream. No device-related SAE occurred. The venous closure rate of the experimental group was 100% (38/38) at 6 months after surgery, and that of the control group was 97.4% (37/38). The difference between the two groups was 2.63% (95% CI:-3.19 to 8.45, Z=4.865, P<0.01), and the 95% CI lower limit of the difference in target venous closure rate between two groups was greater than the non-inferiority threshold of -10.00%.

Conclusion: The early application efficacy of the China-branded novel vein radiofrequency closure treatment system in patients with primary lower extremity varicose veins is not inferior to that of the US-branded system.

Content link:   国产新型静脉射频闭合治疗系统与进口系统应用效果的随机对照研究 - 中华外科杂志 (yiigle.com)