比较 Venefit、射频热疗和腔内射频消融治疗功能不全大隐静脉的随机临床试验患者的 6 年延长研究。
Six Year Extension Study of Patients From a Randomised Clinical Trial Comparing Venefit, Radiofrequency Induced Thermal Therapy, and Endovenous Radiofrequency Ablation for Treatment of Incompetent Great Saphenous Veins.
机构信息
Department of Vascular Surgery, Worcestershire Royal Hospital, Worcester, UK.
Department of Vascular Surgery, Worcestershire Royal Hospital, Worcester, UK.
出版信息
Eur J Vasc Endovasc Surg. 2023 Jul;66(1):94-101. doi: 10.1016/j.ejvs.2023.03.021. Epub 2023 Mar 21.
OBJECTIVE
To compare long term outcomes after great saphenous vein (GSV) treatment with three radiofrequency (RF) thermal devices: Venefit (Closurefast), Radiofrequency Induced Thermal Therapy (RFITT), and Endovenous Radiofrequency (EVRF).
DESIGN
A 72 month follow up of patients who were treated in the randomised 3RF study.
METHODS
A total of 172 participants from the 3RF study were invited to take part in a single visit, long term, follow up study. Failure of GSV closure was assessed with duplex ultrasound (DUS) and constituted the primary outcome. Patients completed questionnaires for secondary outcomes: Aberdeen Varicose Vein Questionnaire (AVVQ), Euroqol 5D (EQ-5D), and patient reported varicose veins measured by counting vein occupying boxes in AVVQ question 1.
RESULTS
Twenty-two patients (12%) had already been re-treated. Of the remainder, 13 (7%) could not be contacted, 20 (11%) declined invitation, and one did not consent. Therefore, 116 (64%) and 95 (53%) participants completed questionnaires and DUS, respectively. Failure of GSV closure on 72 month DUS was 16%, 21%, and 37% for Venefit, RFITT, and EVRF, respectively (p = .14), whilst outcomes for all failures were 14%, 17%, and 44% (p < .001) (Venefit vs. EVRF: p < .001; RFITT vs. EVRF: p < .001; and Venefit vs. RFITT: p = .63). There were no between group differences in AVVQ or EQ-5D scores. Rates of patient reported presence of any varicose veins were high for all groups (97%, 92%, and 97% after Venefit, RFITT, and EVRF, respectively; p = .48). The EVRF treated participants reported more extensive recurrence than the Venefit and RFITT participants (p = .008).
CONCLUSION
Long term technical outcomes after RF ablation for GSV varicose veins were significantly better after Venefit and RFITT compared with EVRF treatment. However, quality of life scores showed no differences after 72 months. Rates of patient reporting any varicose veins were high for all treatments.
CLINICALTRIALS
gov Identifier: NCT04720027.
目的
比较三种射频（RF）热设备治疗大隐静脉（GSV）的长期结果：Venefit（Closurefast）、射频诱导热疗法（RFITT）和静脉内射频（EVRF）。
设计
3RF 研究中接受随机治疗的患者 72 个月随访。
方法
共有 172 名来自 3RF 研究的参与者被邀请参加单次就诊的长期随访研究。使用双功能超声（DUS）评估 GSV 闭合失败，这是主要结局。患者完成了次要结局的问卷调查：Aberdeen 静脉曲张问卷（AVVQ）、欧洲五维健康量表（EQ-5D）和 AVVQ 问题 1 中通过计算静脉占据框数报告的患者静脉曲张。
结果
22 名患者（12%）已经接受了再治疗。其余的，13 名（7%）无法联系，20 名（11%）拒绝邀请，1 名不同意。因此，116 名（64%）和 95 名（53%）参与者分别完成了问卷调查和 DUS。72 个月 DUS 显示，Venefit、RFITT 和 EVRF 的 GSV 闭合失败率分别为 16%、21%和 37%（p=0.14），而所有失败的结果分别为 14%、17%和 44%（p<0.001）（Venefit 与 EVRF：p<0.001；RFITT 与 EVRF：p<0.001；Venefit 与 RFITT：p=0.63）。AVVQ 和 EQ-5D 评分在组间无差异。所有组的患者报告存在任何静脉曲张的比例均较高（分别为 Venefit、RFITT 和 EVRF 后 97%、92%和 97%；p=0.48）。EVRF 治疗的参与者报告的复发程度明显高于 Venefit 和 RFITT 治疗的参与者（p=0.008）。
结论
射频消融治疗 GSV 静脉曲张的长期技术结果，Venefit 和 RFITT 明显优于 EVRF 治疗。然而，72 个月后生活质量评分无差异。所有治疗的患者报告有任何静脉曲张的比例均较高。
临床试验
gov 标识符：NCT04720027。
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