Objective To compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT). Design Randomised, double blind, placebo controlled clinical trial. Setting 28 outpatient clinics specialising in venous thromboembolism. Participants 402 adults (≥18 years) with symptomatic isolated distal DVT. Interventions After receiving standard dose rivaroxaban for six weeks, participants were randomly assigned to receive rivaroxaban 20 mg or placebo once daily for an additional six weeks. Follow-up was for 24 months from study inclusion. Main outcomes measures The primary efficacy outcome was recurrent venous thromboembolism during follow-up after randomisation, defined as the composite of progression of isolated distal DVT, recurrent isolated distal DVT, proximal DVT, symptomatic pulmonary embolism, or fatal pulmonary embolism. The primary safety outcome was major bleeding after randomisation until two days from the last dose of rivaroxaban or placebo. An independent committee adjudicated the outcomes. Results 200 adults were randomised to receive additional rivaroxaban treatment and 202 to receive placebo. Isolated distal DVT was unprovoked in 81 (40%) and 86 (43%) patients, respectively. The primary efficacy outcome occurred in 23 (11%) patients in the rivaroxaban arm and 39 (19%) in the placebo arm (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03, number needed to treat 13, 95% confidence interval 7 to 126). Recurrent isolated distal DVT occurred in 16 (8%) patients in the rivaroxaban arm and 31 (15%) in the placebo arm (P=0.02). Proximal DVT or pulmonary embolism occurred in seven (3%) patients in the rivaroxaban arm and eight (4%) in the placebo arm (P=0.80). No major bleeding events occurred. Conclusions Rivaroxaban administered for six additional weeks in patients with isolated distal DVT who had an uneventful six week treatment course reduces the risk of recurrent venous thromboembolism, mainly recurrent isolated distal DVT, over a two year follow-up without increasing the risk of haemorrhage. Trial registration EudraCT 2016-000958-36; ClinicalTrials.gov [NCT02722447][1]. Deidentified patient level data and the full dataset with low risk of identification are available on reasonable request from the corresponding author after approval by the trial steering committee and the ethics committee of the coordinating centre. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02722447&atom=%2Fbmj%2F379%2Fbmj-2022-072623.atom

中文翻译：

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有症状的孤立性远端深静脉血栓形成患者接受利伐沙班治疗 6 周对比 3 个月：随机对照试验

目的比较利伐沙班两种不同疗程对症状性孤立性远端深静脉血栓形成（DVT）患者的疗效。设计随机、双盲、安慰剂对照的临床试验。设置 28 个静脉血栓栓塞症门诊。参与者 402 名患有症状性孤立性远端 DVT 的成人（≥18 岁）。干预 在接受标准剂量利伐沙班六周后，参与者被随机分配接受利伐沙班 20 毫克或安慰剂，每天一次，持续六周。随访时间为研究纳入后 24 个月。主要结局指标 主要疗效结局是随机化后随访期间的复发性静脉血栓栓塞，定义为孤立性远端 DVT 进展、复发性孤立性远端 DVT、近端 DVT、症状性肺栓塞、或致命的肺栓塞。主要安全性结果是随机化后大出血，直到最后一次服用利伐沙班或安慰剂后两天。一个独立委员会对结果进行了裁决。结果 200 名成人随机接受额外的利伐沙班治疗，202 名成人接受安慰剂。分别有 81 名 (40%) 和 86 名 (43%) 患者无诱因地发生孤立性远端 DVT。利伐沙班组 23 名 (11%) 患者和安慰剂组 39 名 (19%) 患者发生了主要疗效结果（相对风险 0.59，95% 置信区间 0.36 至 0.95；P=0.03，需要治疗的人数 13、95 % 置信区间 7 至 126)。利伐沙班组 16 例 (8%) 患者和安慰剂组 31 例 (15%) 患者发生复发性孤立性远端 DVT (P=0.02)。利伐沙班组 7 名 (3%) 患者和安慰剂组 8 名 (4%) 患者发生近端 DVT 或肺栓塞 (P=0.80)。没有发生大出血事件。结论 6 周治疗过程平安无事的孤立性远端 DVT 患者再服用利伐沙班 6 周可降低复发性静脉血栓栓塞的风险，主要是复发性孤立性远端 DVT，两年随访期间不会增加出血风险。试用注册EudraCT 2016-000958-36；ClinicalTrials.gov [NCT02722447][1]。在试验指导委员会和协调中心伦理委员会批准后，根据相应作者的合理要求，可以提供去识别化的患者水平数据和具有低识别风险的完整数据集。[1]: