A Randomized Controlled Trial Of Endovenous Laser Ablation Versus Mechanochemical Ablation With Clarivein In The Management Of Superficial Venous Incompetence (Lama Trial)

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.