Mohamed AH, Leung C, Wallace T, Smith G, Carradice D, Chetter I, et al.
Annals of surgery. Date of publication 2021 Jun 1;volume 273(6):e188-e195.
1. Ann Surg. 2021 Jun 1;273(6):e188-e195. doi: 10.1097/SLA.0000000000003749.
A Randomized Controlled Trial of Endovenous Laser Ablation Versus
Mechanochemical Ablation With ClariVein in the Management of Superficial Venous
Incompetence (LAMA Trial).
Mohamed AH(1), Leung C, Wallace T, Smith G, Carradice D, Chetter I.
Author information:
(1)Academic Vascular Surgical Unit, Hull York Medical School, Hull, HU3 2JZ, UK.
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.
Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.
DOI: 10.1097/SLA.0000000000003749
PMID: 31977509 [Indexed for MEDLINE]
Conflict of interest statement: The authors report no conflicts of interest.
