A randomized clinical trial found that mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE) techniques as the first-line treatment for truncal vein reflux had similar periprocedural pain and outcomes. These findings were published in JAMA Surgery.
The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs CyanoacrylateAdhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study (ClinicalTrials.gov Identifier: NCT03392753) was conducted at 3 sites in the United Kingdom and Singapore between 2018 and 2020.
Patients (N=167) undergoing endovenous thermal ablation for truncal vein reflux were randomized to receive MOCA (n=83) or CAE (n=84) injections. Pain was evaluated immediately after procedure completion using a 100 mm visual analog scale (VAS) and 10-point numerical rating scale (NRS). At discharge all patients were instructed to wear class 2 compression stockings for 4 days. Patients recorded pain every day for 10 days and filled out quality of life questionnaires at 2 weeks and 3, 6, and 12 months.
The MOCA and CAE study cohorts comprised 63.9% and 54.8% women, aged mean 57 (standard deviation [SD], 16) and 55 (SD, 15) years, BMI was 27.8 (SD, 7.0) and 27.0 (SD, 6.5) kg/m2, median venous clinical severity scores (VCSS) were 4 (interquartile range [IQR], 3-6) and 5 (IQR, 3-7) points, and venous disability scores (VDS) were 1 (IQR, 1-2) and 1 (IQR, 1-2) points, respectively.
During the procedures, the characteristics of treated veins did not differ between groups; however, the CAE group tended to have larger great saphenous vein diameter (median, 6.0 vs 5.0 mm; P =.06) and smaller small saphenous vein diameter (median, 17 vs 28.7 mm; P =.06). In addition, the CAE procedure lasted longer (median, 22.7 vs 17.0 min; P =.001).
Immediately after the procedure, median maximal VAS pain score was 23 (IQR, 10-44) mm and NRS pain score was 3 (IQR, 2-5) mm. Stratified by procedure, no differences in maximum (P =.30) or average (P =.26) pain measured by VAS or maximum (P =.18) or average (P =.66) pain measured by NRS were observed.
No significant group differences were found for any secondary endpoints. Overall, patients reported significant improvements to quality of life (χ²4, 99.48; P <.001), VCSS (χ²4, 121.42; P <.001), and VDS (χ²4, 79.28; P <.001) at 12 months.
Four minor complications of superficial thrombophlebitis (n=3) and thrombus extension (n=1) occurred in the CAE cohort.
This study was limited, as 41% of patients were lost to follow-up owing to the COVID-19 pandemic.
In this study, no significant differences in pain or other outcomes were observed among patients who underwent MOCA or CAE for the treatment of truncal vein reflux. Additional study is needed to evaluate which strategy is the most cost-effective.
These results “suggest that the main determinant as to which interventions to use would be surgeon and patent preference and the cost-effectiveness of each technique,” the study authors noted.
Disclosure: An author declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Pain outcomes following mechanochemical ablation vs cyanoacrylate adhesive for the treatment of primary truncal saphenous vein incompetence: the mocca randomized clinical trial. JAMA Surg. 2022;e220298. doi:10.1001/jamasurg.2022.0298