Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial)

Abstract

Objective: Endothermal techniques have proved to be effective for treatment of incompetent truncal veins. The tumescentless mechanochemical ablation (MOCA) technique has become an alternative treatment modality, but its outcome with regard to endothermal techniques is still unclear.

Methods: A multicenter prospective randomized controlled trial was designed comparing MOCA with radiofrequency ablation (RFA) to treat great saphenous vein incompetence with the hypothesis that MOCA is associated with less postprocedural pain and a comparable anatomic and clinical success rate at 1-year follow-up. Disease-specific quality of life and general health-related quality of life (HRQoL) were measured using questionnaires. Inclusion was terminated prematurely because reimbursement was suspended.

Results: A total of 213 patients (46.3% of intended number of patients) were randomized, of whom 209 were treated (105 in the MOCA group and 104 in the RFA group). Overall median pain scores during the first 14 days were lower after MOCA (0.2 vs 0.5 after RFA; P = .010), although the absolute difference was small. At 30 days, similar complication numbers (MOCA, n = 62; RFA, n = 63) and HRQoL scores (Aberdeen Varicose Vein Questionnaire: MOCA, 8.9; RFA, 7.6; P = .233) were observed. Hyperpigmentation was reported in seven patients in the MOCA group and two patients in the RFA group (P = .038). In the MOCA group, there were four complete failures (3.8%) compared with none in the RFA group (P = .045), although in one patient at 1 year, the vein showed occlusion. Median 30-day Venous Clinical Severity Score (VCSS) was significantly lower at 30 days after MOCA (1.0 vs 2.0 in the RFA group; P = .001), whereas VCSS was comparable at baseline (MOCA, 4.0; RFA, 5.0; P = .155). The 1- and 2-year anatomic success rate was lower after MOCA (83.5% and 80.0%) compared with RFA (94.2% and 88.3%; P = .025 and .066), mainly driven by partial recanalizations. After 2 years of follow-up, no differences were observed in the number of complete failures. Similar clinical success rates at 1 year (MOCA, 88.7%; RFA, 93.2%; P = .315) and 2 years (MOCA, 93.0%; RFA, 90.4%; P = .699) and no differences in HRQoL scores on the Aberdeen Varicose Vein Questionnaire at 1 year (MOCA, 7.5; RFA, 7.0; P = .753) and 2 years (MOCA, 5.0%; RFA, 4.8%; P = .573) were observed. There were two cardiac serious adverse events, a ventricular fibrillation in the MOCA group (1 year) and an unstable angina in the RFA group (2 years). One deep venous thrombosis occurred in the RFA group on 1-year duplex ultrasound, without clinical sequelae.

Conclusions: Unilateral treatment with MOCA in the short term resulted in less postoperative pain but more hyperpigmentation compared with RFA and a faster improvement in VCSS. More anatomic failures were reported after MOCA, mostly driven by partial recanalizations, but both techniques were associated with similar clinical outcomes at 1 year and 2 years.

Trial registration: ClinicalTrials.gov NCT01936168.

Keywords: Great saphenous vein incompetence; Mechanochemical ablation; Quality of life; Radiofrequency ablation; Randomized controlled trial.