意大利英苏布里亚大学Walter Ageno团队比较了利伐沙班对有症状的孤立性远端深静脉血栓患者治疗6周和3个月的效果。相关论文于2022年11月23日发表在《英国医学杂志》上。

为了比较利伐沙班对有症状的孤立性远端深静脉血栓形成（DVT）患者的两种不同治疗时间的效果，研究组在28个专门治疗静脉血栓栓塞症的门诊诊所进行了一项随机、双盲、安慰剂对照临床试验。共招募了402名有症状的孤立性远端DVT成年患者（≥18岁）。在接受标准剂量的利伐沙班六周后，参与者被随机分配，分别接受20 mg的利伐沙班或安慰剂治疗，每天一次，持续六周。从纳入研究开始随访24个月。

主要疗效结局是随机分组后随访期间复发性静脉血栓栓塞，定义为孤立性远端DVT、复发性孤立性远端DVT、近端DVT和症状性肺栓塞或致命性肺栓塞的综合进展。主要安全性结局是随机化后大出血，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评定。

200名成年患者随机接受了额外的利伐沙班治疗，202名接受了安慰剂治疗。分别有81例（40%）和86例（43%）患者发生无诱因的孤立性远端DVT。利伐沙班组中有23例（11%）患者发生主要疗效结局，安慰剂组中有39例（19%），相对风险为0.59，组间差异显著。

利伐沙班组中有16例（8%）患者出现复发性孤立性远端DVT，安慰剂组中有31例（15%），组间差异显著。利伐沙班组中有7名（3%）患者发生近端DVT或肺栓塞，安慰剂组中有8名（4%），组间差异不显著。未发生重大出血事件。

研究结果表明，在为期6周的治疗过程中，对孤立性远端DVT患者再给予6周的利伐沙班，在2年的随访中减少了复发性DVT的风险，主要是复发性孤立性远端DVT，且不会增加出血的风险。

附：英文原文

Title: Rivaroxaban treatment for six weeks versus three months in patients with symptomatic isolated distal deep vein thrombosis: randomised controlled trial

Author: Walter Ageno, Lorenza Bertù, Eugenio Bucherini, Giuseppe Camporese, Francesco Dentali, Matteo Iotti, Gianfranco Lessiani, Roberto Parisi, Paolo Prandoni, Michelangelo Sartori, Adriana Visonà, Elisabetta Bigagli, Gualtiero Palareti

Issue&Volume: 2022/11/23

Abstract:

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.

DOI: 10.1136/bmj-2022-072623

Source: https://www.bmj.com/content/379/bmj-2022-072623