A Randomized Controlled Trial of Endovenous Laser Ablation Versus Mechanochemical Ablation With ClariVein in the Management of Superficial Venous Incompetence (LAMA Trial)
A Randomized Controlled Trial of Endovenous Laser Ablation Versus Mechanochemical Ablation With ClariVein in the Management of Superficial Venous Incompetence (LAMA Trial)
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DOI：
10.1097/sla.0000000000003749
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发表时间：
2021-06-01
影响因子：
9
通讯作者：
Chetter, Ian
中科院分区：
文献类型：
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作者：
Mohamed, Abduraheem Hussein;Leung, Clement;Chetter, Ian
目的：本RCT比较了EVLA和莫卡术后的临床、技术和生活质量结局。背景资料概要：热消融是目前SVI的主要治疗方法。不需要使用肿胀麻醉的较新的非热疗方法已经开发出来。这些新方法的潜在优势应该在随机对照试验中进行测试，以确定它们在未来SVI治疗中的作用。方法：该单中心RCT入组了症状性、单侧、单轴SVI患者。合格的患者被同等随机分配至EVLA或莫卡组，必要时均伴随静脉切除术。关节主要结局为术中轴向消融疼痛评分和1年时的解剖学闭塞。次要结局包括术后疼痛、静脉临床严重程度评分（VCSS）、生活质量（Aberdeen静脉曲张问卷和EuroQol 5域效用指数）、患者满意度和并发症发生率。结果：150例患者在两种干预措施之间平均随机分配。两组报告的术中疼痛评分均较低;在100 mm视觉模拟量表上，轴向EVLA期间的疼痛评分为22分（9-44分），而莫卡期间为15分（9-29分）; P = 0.210。1年时，EVLA后双功衍生的解剖学闭塞率为63/69（91%），而莫卡组为53/69（77%）; P = 0.020。两组治疗后VCSS和AVVQ均显著改善，组间无显著差异。中位VCSS从6（5-8）改善至1年时的0（0-1）; P < 0.001。中位AVVQ从13.8（10.0-17.7）改善至2.0（0.0-4.9）; P < 0.001。莫卡组1例患者发生DVT。结论：EVLA和莫卡治疗SVI均高度有效;患者在疾病严重程度、症状和QoL方面均显著改善。两者均导致手术疼痛较低，恢复时间较短。EVLA后轴向闭塞率较高。需要长期随访以评估再通对临床复发率的影响。
Objective: This RCT compares the clinical, technical and quality of life outcomes after EVLA and MOCA. Summary of Background Data: Thermal ablation is the current mainstay treatment for SVI. Newer nonthermal methods of treatment have been developed which do not require the use of tumescent anesthesia. The potential advantages of these newer methods should be tested in RCTs to ascertain their role in the future treatments of SVI. Methods: This single-center RCT enrolled patients with symptomatic, unilateral, single-axis SVI. Eligible patients were equally randomized to either EVLA or MOCA, both with concomitant phlebectomy when necessary. The joint primary outcomes were intraprocedural axial ablation pain scores and anatomical occlusion at 1 year. Secondary outcomes included postprocedural pain, venous clinical severity score (VCSS), quality of life (Aberdeen varicose veins questionnaire and EuroQol 5-domain utility index), patient satisfaction and complication rates. Results: One hundred fifty patients were randomized equally between the 2 interventions. Both groups reported low intraprocedural pain scores; on a 100 mm visual analog scale, pain during axial EVLA was 22 (9-44) compared to 15 (9-29) during MOCA; P = 0.210. At 1 year, duplex derived anatomical occlusion rates after EVLA were 63/69 (91%) compared to 53/69 (77%) in the MOCA group; P = 0.020. Both groups experienced significant improvement in VCSS and AVVQ after treatment, without a significant difference between groups. Median VCSS improved from 6 (5-8) to 0 (0-1) at one year; P < 0.001. Median AVVQ improved from 13.8 (10.0-17.7) to 2.0 (0.0-4.9); P < 0.001. One patient in the MOCA group experienced DVT. Conclusions: Both EVLA and MOCA were highly efficacious in treating SVI; patients improved significantly in terms of disease severity, symptoms, and QoL. Both resulted in low procedural pain with a short recovery time. Axial occlusion rates were higher after EVLA. Long term follow-up is warranted to assess the effect of recanalization on the rate of clinical recurrence.