Rivaroxaban versus fondaparinux for thromboprophylaxis after endovenous laser ablation
Rivaroxaban versus fondaparinux for thromboprophylaxis after endovenous laser ablation
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DOI：
10.1016/j.jvsv.2017.04.017
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发表时间：
2017-11-01
影响因子：
3.2
通讯作者：
Staub, Daniel
中科院分区：
文献类型：
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作者：
Keo, Hong H.;Baumann, Frederic;Staub, Daniel
目的：静脉腔内热诱导血栓形成（EHIT）和深静脉血栓形成（DVT）是浅表静脉腔内热消融术后的常见并发症。我们调查了利伐沙班在预防静脉腔内激光消融术（EVLA）后EH IT和DVT的疗效。方法：我们回顾性分析了一系列连续的接受EVLA治疗的C-2至C-6级下肢静脉曲张患者。EVLA后，所有患者均接受口服利伐沙班（10 mg）或皮下注射磺达肝癸钠（2.5 mg），每日一次，连续3天。主要终点是1周和4周后通过多普勒超声成像评估的EHIT或DVT的复合终点。EHIT 1级定义为血栓延伸至隐股交界处。延伸至深静脉系统，横截面积阻塞> 50%。EHIT 4级为股静脉完全闭塞。次要终点为轻微或严重出血、感觉异常和皮肤灼伤。结果：2009年2月至2015年12月，391例患者（473条肢体）接受了干隐静脉EVLA治疗。比较利伐沙班组和磺达肝癸钠组，1周后166例患者中有13例（7.8%）和225例患者中有14例（6.2%）发生主要终点，4周后166例患者中有13例（7.8%）和225例患者中有15例（6.7%）发生主要终点（P = .659）。EHIT 1级20例（5.1%），EH IT 2级5例（1.3%）。没有患者患有EHIT 3级或4级。利伐沙班组DVT的发生率为1/166（0.6%），磺达肝癸钠组为2/225（0.9%）（P= 0.750）。166例患者中的17例（10.2%）和225例患者中的20例（8.9%）分别发生轻微出血事件（P = 0.652）。未观察到大出血事件。利伐沙班组和磺达肝癸钠组分别有12.5%和17.8%的患者出现感觉异常。结论：利伐沙班提供了一种口服药物治疗方法，与磺达肝癸钠相比，在预防EHIT和DVT方面没有差异，且不增加出血风险。
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 EH IT and DVT after endovenous laser ablation (EVLA).Methods: We retrospectively analyzed a consecutive series of patients presenting with truncal varicosis class C-2 to C-6 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% 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 EH IT 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.