Vascular Surgery, Manchester University NHS Foundation Trust, Manchester, UK; Vascular Surgery, Bolton Hospitals NHS Foundation Trust, Bolton, UK.
Vascular Surgery, Manchester University NHS Foundation Trust, Manchester, UK.
Eur J Vasc Endovasc Surg. 2020 Jul;60(1):108-117. doi: 10.1016/j.ejvs.2020.03.014. Epub 2020 Apr 8.
Post-procedure limb compression, hitherto routine following open varicose vein surgery, has been extended to endovenous procedures. However, no robust evidence exists to support this practice. Most of the previous studies have focused on the ideal duration of compression. This study evaluates the clinical and patient reported outcomes with and without post-procedure leg compression following radiofrequency ablation (RFA).
This single centre, prospective, non-inferiority randomised controlled trial recruited adult patients, into two groups (A: RFA with compression stocking for two weeks, B: RFA alone). The primary outcome was ultrasound determined target vein obliteration at 12 weeks. Secondary outcome measures included a Quality of Life (QoL) score [Aberdeen Varicose Vein Severity Score (AVSS) and Revised Venous Clinical Severity Score (RVCSS)], patient satisfaction, pain score, and complications.
In total, 100 consecutive patients were recruited (A: 51; B: 49) classified as clinical class C2-C6 of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification. At 12 weeks the occlusion rate of the target vein was similar in both groups at 98% (n = 47) and 98% (n = 45), respectively (p = 1.0). There was no statistically significant difference in mean AVSS 6 vs. 5.0 (mean difference -1, 95% CI -2 - 3, p = .57) and mean RVCSS 3 vs. 4 (mean difference 1, 95% CI -1 - 2, p = .46) scores at 12 weeks. Comparable patient satisfaction scores were observed (p = .72) and pain score 2.0 vs. 2.0 (p = .92) were achieved in both groups. Two patients in each group developed deep vein thrombosis at two weeks follow up (p = 1.0 for above the knee and p = 1.0 for below the knee).
The clinical and patient reported outcomes following RFA without compression are no worse than with compression. This trial supports the conclusion that the widely practised use of compression after RFA adds no clinical benefit for the patients. However, a much larger study, preferably a multicentre trial, may be required to confirm this conclusion.
在开放静脉手术之后，肢体加压已成为静脉内手术的常规程序。然而，目前尚无确凿证据支持这一做法。大多数先前的研究都集中在加压的理想持续时间上。本研究评估了射频消融（RFA）后使用和不使用腿部术后加压的临床和患者报告的结果。
这项单中心前瞻性非劣效性随机对照试验招募了成年患者，分为两组（A：使用压缩袜进行 RFA 治疗两周，B：单独进行 RFA）。主要结局是在 12 周时通过超声确定目标静脉闭塞。次要结局指标包括生活质量评分（阿伯丁静脉疾病严重程度评分[AVSS]和修订静脉临床严重程度评分[RVCSS]）、患者满意度、疼痛评分和并发症。
共招募了 100 例连续患者（A：51 例；B：49 例），按临床-病因-解剖-病理生理（CEAP）分类的 C2-C6 临床分类。在 12 周时，两组的目标静脉闭塞率分别为 98%（n=47）和 98%（n=45），差异无统计学意义（p=1.0）。12 周时，AVSS 平均值从 6 分变为 5.0 分（平均差值-1，95%CI-2 至 3，p=0.57），RVCSS 平均值从 3 分变为 4 分（平均差值 1，95%CI-1 至 2，p=0.46），差异均无统计学意义。两组患者满意度评分相似（p=0.72），疼痛评分均为 2.0 分（p=0.92）。两组各有 2 例患者在两周随访时发生深静脉血栓形成（膝上 p=1.0，膝下 p=1.0）。
RFA 后不使用加压的临床和患者报告的结果并不比使用加压差。本试验支持这样的结论，即在 RFA 后广泛使用加压对患者没有临床益处。然而，可能需要进行一项更大的研究，最好是一项多中心试验，以证实这一结论。
