A randomized clinical trial found that mechanochemical ablation (MOCA) and cyanoacrylate adhesive (CAE) injection techniques as first-line treatment for truncal venous reflux had similar pain and periprocedural outcomes. These findings were published in JAMA Surgery.
The Multicentre Randomized Clinical Trial II comparing mechanochemical ablation with cyanoacrylate adhesive for the treatment of primary truncal saphenous vein incompetence (ClinicalTrials.gov Identifier: NCT03392753) was conducted at 3 sites in the UK and Singapore between 2018 and 2020.
Patients (N=167) undergoing endovenous thermal ablation for truncal venous reflux were randomized to receive injections of MOCA (n=83) or CAE (n=84). Pain was assessed immediately after completion of the procedure using a 100 mm visual analogue scale (VAS) and a 10-point numerical rating scale (NRS). At discharge, all patients were instructed to wear class 2 compression stockings for 4 days. Patients recorded pain daily for 10 days and completed quality of life questionnaires at 2 weeks and 3, 6 and 12 months.
The cohorts of the MOCA and CAE studies included 63.9% and 54.8% of women, aged on average 57 years (standard deviation [SD]16) and 55 (SD, 15) years, BMI was 27.8 (SD, 7.0) and 27.0 (SD, 6.5) kg/m2median 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 the treated veins did not differ between the groups; however, the CAE group tended to have a larger great saphenous vein diameter (median, 6.0 vs. 5.0 mm; P =.06) and small diameter of the small saphenous vein (median, 17 vs. 28.7 mm; P =.06). Additionally, the CAE procedure took longer (median, 22.7 vs 17.0 min; P =.001).
Immediately after surgery, the median maximum VAS pain score was 23 (IQR, 10-44) mm and the NRS pain score was 3 (IQR, 2-5) mm. Stratified by procedure, no difference in the maximum (P =.30) or average (P =.26) pain measured by VAS or maximum (P =.18) or average (P = 0.66) pain measured by the NRS was observed.
No significant differences between the groups were found for the secondary endpoints. Overall, patients reported significant improvements in quality of life (χ²499.48; P <.001 vcss>4121.42; P <.001 and vds>479.28; P <.001 at months.>
Four minor complications of superficial thrombophlebitis (n=3) and thrombus extension (n=1) occurred in the CAE cohort.
This study was limited since 41% of patients were lost to follow-up due to the COVID-19 pandemic.
In this study, no significant differences in pain or other outcomes were observed in patients who underwent MOCA or CAE for the treatment of truncal venous reflux. Further study is needed to assess which strategy is more profitable.
These results “suggest that the primary determinant of which interventions to use would be surgeon and patent preference and the cost-effectiveness of each technique,” the study authors noted.
Disclosure: One author has declared industry affiliations. Please refer to the original article for a full list of disclosures.
Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Pain outcomes after mechanochemical ablation vs cyanoacrylate adhesive for the treatment of primary truncal saphenous vein incompetence: the Mocca randomized clinical trial. JAMA Surgery. 2022;e220298. doi:10.1001/jamasurg.2022.0298