Department of Internal Medicine, Østfold Hospital, Kalnes, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Hematology, Akershus University Hospital, Lørenskog, Norway.
Thromb Res. 2018 Mar;163:6-11. doi: 10.1016/j.thromres.2018.01.013. Epub 2018 Jan 8.
Despite treatment of acute deep vein thrombosis (DVT) with low molecular weight heparin and warfarin, up to 50% of patients develop post-thrombotic syndrome (PTS). Our aims were to assess whether treatment of DVT with rivaroxaban would reduce the rate of subsequent PTS and improve health-related quality of life (HRQoL) as compared to conventional anticoagulation with low molecular weight heparin (LMWH)/warfarin.
Consecutive patients with an objectively confirmed DVT diagnosed between 2011 and 2014 and treated with either rivaroxaban or warfarin were included in this study 24 (±6) months after DVT. PTS was assessed using the Patient Reported Villalta scale. HRQoL was assessed using the EQ-5D-3L and VEINES-QOL/Sym questionnaires.
Total 309 patients were included, 161 (52%) treated with rivaroxaban and 148 (48%) with warfarin. Rivaroxaban-treated patients had a lower rate of PTS (45%: 95% confidence interval [CI] 37 to 52) compared to those treated with warfarin (59%: 95% CI 51 to 66, absolute risk difference 14%: 95% CI 3 to 25, odds ratio (OR) 0.6, P = .01). The adjusted OR for development of PTS was 0.5 (95% CI: 0.3 to 0.8, P = .01) in patients treated with rivaroxaban. HRQoL was significantly better in the rivaroxaban-treated patients. HRQoL measured by EQ-VAS (P = .002) and VEINES-QOL/Sym (P = .005/P = .003) remained significantly better after adjustment.
Patients treated with rivaroxaban had lower rate of PTS and better HRQoL after DVT compared to patients treated with warfarin. However, these results should be interpreted with caution due to the limitation imposed by study design.
尽管使用低分子肝素和华法林治疗急性深静脉血栓形成（DVT），仍有多达 50%的患者发生血栓后综合征（PTS）。我们的目的是评估与低分子肝素（LMWH）/华法林常规抗凝相比，使用利伐沙班治疗 DVT 是否会降低随后 PTS 的发生率并改善健康相关生活质量（HRQoL）。
本研究纳入了 2011 年至 2014 年间确诊的并接受利伐沙班或华法林治疗的连续患者，在 DVT 后 24（±6）个月评估 PTS。采用患者报告的 Villalta 量表评估 PTS。使用 EQ-5D-3L 和 VEINES-QOL/Sym 问卷评估 HRQoL。
共纳入 309 例患者，其中 161 例（52%）接受利伐沙班治疗，148 例（48%）接受华法林治疗。与华法林治疗组（59%：95%CI51-66）相比，利伐沙班组（45%：95%CI37-52）PTS 发生率较低，绝对风险差异为 14%：95%CI3-25，比值比（OR）为 0.6，P=0.01）。调整后的 OR 表明，利伐沙班治疗组 PTS 的发生率为 0.5（95%CI：0.3-0.8，P=0.01）。利伐沙班治疗患者的 HRQoL 显著改善。调整后，EQ-VAS（P=0.002）和 VEINES-QOL/Sym（P=0.005/P=0.003）的 HRQoL 仍显著改善。
与华法林治疗组相比，接受利伐沙班治疗的 DVT 患者 PTS 发生率较低，HRQoL 较好。然而，由于研究设计的限制，这些结果的解释应该谨慎。
