MARADONA 2019.

Study characteristics
Methods	Study design: multicentre randomised control trial (single‐blinded) Country: the Netherlands Setting/Location: Department of surgery, Rijinstate Arnhem; Department of surgery, OLVG; Department of surgery, BovenIJ Hospital Amsterdam; Department of vascular surgery, St Antonius Hospital Nieuwegein; and the division of vascular surgery, UMCG, Groningen Source of funding: ‘investigator‐initiated study supported by Vascular Insights Ltd’ Intention‐to‐treat analysis: yes
Participants	No of participants randomised: n = 213 (using an online randomisation module with block randomisation per site); MOCA n = 107; RFA n =106 No of participants analysed: MOCA 1 yr analysed ITT n = 101 PP n = 99, 2 yr ITT n = 95, PP n = 93 RFA = 1 yr analysed ITT n = 99, PP n = 99, 2 yr ITT n = 97, PP n = 97 Exclusions post‐randomisation: MOCA n = 5, RFA n = 3 Losses to follow‐up: MOCA 1 yr n = 20, 2 yr n = 19; RFA 1 yr n = 32. 2 yr n = 16 Age ‐ median years (IQR): MOCA 54.9 (16.3 ‐ 81.2); RFA 53.4 (22.6 – 77.9) Sex percent female: MOCA 62.4; RFA 59.3 Inclusion criteria: GSV incompetence (> 3 mm and < 12 mm) with CEAP C2 to C5 Exclusion criteria: active ulcer, previous surgery or treatment of ipsilateral GSV, use of oral anticoagulants, pregnancy or lactation, previous DVT, immobilisation, contraindication or known allergy to sclerosant, coagulation disorders or increased risk of thromboembolism, severe renal or liver insufficiency and severe peripheral artery disease.
Interventions	Treatment(s): MOCA USS guidance, Clarivein tip placed 5 mm below orifice of superficial epigastric vein or 2 cm below the SFJ. Wire activated for 10 sec, device withdrawn at speed of 7 s/cm while liquid sclerosant continuously injected using 2 mL of 3% polidocanol for first 10 cm ‐ 15 cm and 1.5% for remainder. Control: RFA, Closure fast device positioned as above, TA (500 mL of NaCl including 20 mL of 8.4% sodium bicarbonate and 50 mL of lidocaine 1% with epinephrine 1:200,000 injected along entire segment) every 20 sec 7 cm segment of GSV treated after pullback. Most proximal segment treated twice. Both groups had compression stockings continuously for first 24 hr then daily for first 2 weeks Duration: 30 days (± 7 days), 1 yr (± 1 month), 2 yrs (± 2 months)
Outcomes	Primary outcomes: post‐procedural pain evaluated using 100‐point visual analogue scale two weeks post procedure. Anatomic success at one year. Secondary outcomes: anatomic success, clinical success using VCSS, 30‐day morbidity, disease‐specific quality of life (AVVQ), general health‐related (HR) QoL (SF‐36), time to return to daily activities/work, re‐intervention rate and additional varicose vein treatment during 2‐year follow‐up. Recurrence definition: recanalisation (failure of treatment) which could be complete or partial (> 10 cm) Success definitions: initial success of the procedure (i.e. catheter placed at defined location and GSV treated without technical problems). Anatomic success was occlusion of the treated GSV segment, objective by DUS. Failure of treatment is recanalisation which could be complete or partial (> 10 cm). Clinical success was defined as improvement in the VCSS of > 1 point. Duration: two years
Notes	Phlebectomies: ‘No concomitant phlebectomy or sclerotherapy was scheduled to be performed unless indicated by the treating physician’. In the MOCA group. 1 participant had phlebectomies, none did in the RFA arm Notes: Only managed to randomise 46.3% of intended. Reimbursement of MOCA was suspended and enrolment was stopped at the end of 2014; this was not reinstated for over a year. Trial was therefore advised by the ethics committee to terminate the study. In both groups, 6 participants had adjunctive therapies; however, these were reported and sub‐analysis done (median pain score similar).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation performed using online randomisation module with block randomisation per site
Allocation concealment (selection bias)	High risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	DUS was performed by vascular technicians who were blinded for treatment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Dropouts recorded, no reasons provided; reported as ‘unknown why’
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Unclear risk	Sample size calculation to assess anatomical and clinical success rate at one year showed the need for 230 participants in each arm (accounting for a 10% dropout rate). Study only managed to recruit 46% of this number.