Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Department of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, Ontario, Canada.
Semin Thromb Hemost. 2020 Nov;46(8):977-985. doi: 10.1055/s-0040-1718891. Epub 2020 Dec 23.
The role of rivaroxaban in the treatment of leg superficial venous thrombosis (SVT) is uncertain. This article aims to determine if rivaroxaban is an effective and safe treatment for leg SVT. Patients with symptomatic leg SVT of at least 5 cm length were randomized to 45 days of rivaroxaban 10 mg daily or to placebo, and followed for a total of 90 days. Treatment failure (required a nonstudy anticoagulant; had proximal deep vein thrombosis or pulmonary embolism; or had surgery for SVT) at 90 days was the primary efficacy outcome. Secondary efficacy outcomes included leg pain severity, and venous disease-specific and general health-related quality of life over 90 days. Major bleeding at 90 days was the primary safety outcome. Poor enrollment led to the trial being stopped after 85 of the planned 600 patients were randomized to rivaroxaban ( = 43) or placebo ( = 42). One rivaroxaban and five placebo patients had a treatment failure by 90 days (absolute risk reduction = 9.0%, 95% confidence interval: -22 to 5.9%). Leg pain improvement did not differ at 7 ( = 0.16) or 45 days ( = 0.89), but was greater with rivaroxaban at 90 days ( = 0.011). There was no difference in venous disease-specific ( = 0.99) or general health-related ( = 0.37) quality of life over 45 days. There were no major bleeds or deaths in either group. There were no identifiable differences in efficacy or safety between rivaroxaban and placebo in patients with symptomatic SVT but comparisons were undermined by a much smaller than planned sample size (NCT1499953).
利伐沙班治疗下肢浅静脉血栓（SVT）的作用尚不确定。本文旨在确定利伐沙班是否是治疗下肢 SVT 的有效且安全的方法。患有至少 5cm 长症状性下肢 SVT 的患者被随机分为 45 天利伐沙班 10mg 每日一次或安慰剂组，并随访总计 90 天。90 天时的治疗失败（需要非研究抗凝药物；出现近端深静脉血栓或肺栓塞；或因 SVT 进行手术）是主要疗效终点。次要疗效终点包括 90 天内腿部疼痛严重程度以及静脉疾病特异性和一般健康相关生活质量。90 天时的主要安全性终点为大出血。由于入组人数不佳，该试验在计划入组的 600 例患者中随机分为利伐沙班组（ = 43）或安慰剂组（ = 42）后 85 例时停止。90 天时，1 名利伐沙班组和 5 名利伐沙班组患者治疗失败（绝对风险降低率 = 9.0%，95%置信区间：-22 至 5.9%）。7 天时（ = 0.16）和 45 天时（ = 0.89）腿部疼痛改善无差异，但利伐沙班组 90 天时（ = 0.011）更大。45 天时，静脉疾病特异性（ = 0.99）和一般健康相关（ = 0.37）生活质量无差异。两组均无重大出血或死亡。在有症状性 SVT 的患者中，利伐沙班与安慰剂相比，疗效和安全性无明显差异，但由于计划样本量明显小于预期，比较结果受到影响（NCT0149993）。
