Rivaroxaban versus fondaparinux for thromboprophylaxis after endovenous laser ablation

Abstract

Objective: Endovenous heat-induced thrombosis (EHIT) and deep venous thrombosis (DVT) are well-known complications after superficial endovenous thermoablation. We investigated the efficacy of rivaroxaban in preventing EHIT and DVT after endovenous laser ablation (EVLA).

Methods: We retrospectively analyzed a consecutive series of patients presenting with truncal varicosis class C₂ to C₆ undergoing EVLA. After EVLA, all patients received oral rivaroxaban (10 mg) or subcutaneous fondaparinux (2.5 mg) once daily for 3 consecutive days. The primary end point was the composite of EHIT or DVT assessed by duplex ultrasound imaging after 1 and 4 weeks. EHIT class 1 was defined as the thrombus extending to the saphenofemoral junction. Extension into the deep venous system with a cross-sectional area obstruction <50% was considered EHIT class 2. EHIT class 3 was defined as >50% cross-sectional area obstruction. EHIT class 4 was total occlusion of the femoral vein. The secondary end points were minor or major bleeding, paresthesia, and skin burns.

Results: Between February 2009 and December 2015, 391 patients (473 limbs) were treated with EVLA of the truncal saphenous vein. The primary end point occurred in 13 of 166 (7.8%) and 14 of 225 (6.2%) after 1 week and in 13 of 166 (7.8%) and 15 of 225 (6.7%) after 4 weeks comparing the rivaroxaban and fondaparinux groups (P = .659). EHIT class 1 was observed in 20 patients (5.1%) and EHIT class 2 in five (1.3%). No patients had EHIT class 3 or 4. The incidence of DVT was one of 166 (0.6%) in the rivaroxaban group and two of 225 (0.9%) in the fondaparinux group (P = .750). Minor bleeding events occurred in 17 of 166 patients (10.2%) and in 20 of 225 patients (8.9%), respectively (P = .652). No major bleeding events were observed. Paresthesia was observed in 12.5% in the rivaroxaban group and in 17.8% in the fondaparinux group. No skin burns were observed.

Conclusions: Rivaroxaban offers an oral medication approach showing no difference in preventing EHIT and DVT compared with fondaparinux, without increased bleeding risk.