Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.
Br J Surg. 2018 Dec;105(13):1759-1767. doi: 10.1002/bjs.10961. Epub 2018 Aug 22.
Clinical guidelines recommend endovenous laser ablation (EVLA) over surgery based on short-term evidence, yet there are few studies reporting mid- to long-term outcomes. The aim of this study was to report the 5-year outcomes from an RCT of surgery versus EVLA for treatment of symptomatic great saphenous varicose veins.
Patients with symptomatic varicose veins due to great saphenous vein (GSV) incompetence were followed up 5 years after enrolment in a randomized trial of either surgery (saphenofemoral junction ligation, GSV strip to the knee and multiple avulsions of varicosities) or EVLA plus multiple avulsions. Outcomes included: clinical recurrence, defined as new varicose veins greater than 3 mm in diameter; Venous Clinical Severity Score (VCSS); quality of life measured by means of Short Form 36, EuroQol Five Dimensions (EQ-5D™) and Aberdeen Varicose Vein Questionnaire (AVVQ); patient satisfaction; and duplex ultrasound examination (DUS) findings.
Some 218 of the 276 patients enrolled in the trial (79·0 per cent) were available for follow-up. Clinical recurrence was more frequent following surgery than EVLA at 5 years (34·3 versus 20·9 per cent; P = 0·010). Both groups demonstrated sustained significant improvements at 5 years over baseline in VCSS (surgery: median (i.q.r.) 1 (0-2) from 4 (3-5), P < 0·001; EVLA: 0 (0-1) from 4 (3-5), P < 0·001), AVVQ (surgery: 4·59 (0·56-9·78) from 13·69 (9·81-18·11), P < 0·001; EVLA: 3·35 (0·17 to 6·55) from 12·73 (9·41-17·32), P < 0·001) and EQ-5D™ (surgery: 1·000 (0·796-1·000) from 0·859 (0·796-1·000), P = 0·002; EVLA: 1·000 (0·796-1·000) from 0·808 (0·796-1·000), P = 0·002). VCSS was better for EVLA than surgery at 5 years (P = 0·031). Technical success assessed by DUS remained high at 5 years (85·4 per cent for surgery and 93·2 per cent for EVLA; P = 0·074). DUS-detected anatomical patterns of recurrence differed between the groups.
EVLA was more effective than surgery in preventing clinical recurrence 5 years after treatment of great saphenous varicose veins. Patient-reported outcome measures were similar. Registration number: NCT00759434 (http://www.clinicaltrials.gov).
临床指南基于短期证据推荐静脉内激光消融术（EVLA）优于手术，但很少有研究报告中期至长期结果。本研究旨在报告一项针对大隐静脉曲张治疗的手术与 EVLA 随机对照试验（RCT）的 5 年结果。
患有大隐静脉（GSV）功能不全引起的症状性静脉曲张的患者在入组一项随机试验 5 年后接受随访，该试验比较了手术（股隐交界处结扎、GSV 至膝部剥脱和多处曲张静脉撕脱）与 EVLA 加多处撕脱的治疗效果。结果包括：临床复发，定义为新出现的直径大于 3 毫米的静脉曲张；静脉临床严重程度评分（VCSS）；通过简短 36 项健康调查（SF-36）、欧洲五维健康量表（EQ-5D™）和爱丁堡静脉曲张问卷（AVVQ）测量的生活质量；患者满意度；以及双功能超声检查（DUS）结果。
在这项试验中，276 名入组患者中有 218 名（79.0%）可进行随访。5 年后，手术组的临床复发率高于 EVLA 组（34.3%比 20.9%；P=0.010）。两组在 5 年时均持续显著优于基线时的 VCSS（手术：中位数（IQR）从 4（3-5）改善至 0（0-1），P<0.001；EVLA：从 4（3-5）改善至 0（0-1），P<0.001）、AVVQ（手术：从 13.69（9.81-18.11）改善至 4.59（0.56-9.78），P<0.001；EVLA：从 12.73（9.41-17.32）改善至 3.35（0.17-6.55），P<0.001）和 EQ-5D™（手术：从 0.859（0.796-1.000）改善至 1.000（1.000-1.000），P=0.002；EVLA：从 0.808（0.796-1.000）改善至 1.000（1.000-1.000），P=0.002）。5 年后，EVLA 的 VCSS 优于手术（P=0.031）。5 年后 DUS 评估的技术成功率仍然很高（手术为 85.4%，EVLA 为 93.2%；P=0.074）。DUS 检测到的复发解剖模式在两组之间存在差异。
与手术相比，EVLA 在治疗大隐静脉曲张 5 年后更有效地预防临床复发。患者报告的结果测量指标相似。注册号：NCT00759434（http://www.clinicaltrials.gov）。
