瑞舒伐他汀预防血栓形成后综合征：一项多中心随机对照试验（SAVER）。

Prevention of post-thrombotic syndrome with rosuvastatin: A multicenter randomized controlled pilot trial (SAVER).

作者信息

Delluc Aurélien, Ghanima Waleed, Kovacs Michael J, Shivakumar Sudeep, Kahn Susan R, Sandset Per Morten, Kearon Clive, Mallick Ranjeeta, Rodger Marc A

机构信息

Department of Medicine (Division of Hematology) and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada.

Department of Research, Ostfold Hospital Trust, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

出版信息

Thromb Res. 2022 May;213:119-124. doi: 10.1016/j.thromres.2022.03.014. Epub 2022 Mar 19.

DOI:10.1016/j.thromres.2022.03.014

PMID:35344784

Abstract

BACKGROUND

Post-thrombotic syndrome (PTS) is one of the most frequent complications of venous thromboembolism (VTE) leading to considerable morbidity and cost. Apart from appropriate anticoagulation, there is no drug or medical intervention that helps to prevent PTS. We conducted a multicenter randomized controlled trial to determine whether rosuvastatin can prevent PTS.

METHODS

312 patients receiving standard anticoagulation for a newly diagnosed VTE were randomly allocated to adjuvant rosuvastatin 20 mg once daily for 180 days (n = 155) or no rosuvastatin (n = 157). At the last study visit (Day 180 ± 21), an independent observer who was blinded to study treatment performed a PTS assessment using the Villalta scale. The primary clinical outcome of the trial was mean Villalta score at Day 180. We also explored the presence of PTS as defined by Villalta score > 4 at Day 180. Patients mean age was 46.7 ± 10.8 years, 55.8% were female.

RESULTS

At Day 180, the Villalta score was 3.5 ± 0.3 in the rosuvastatin arm vs. 3.3 ± 0.3 in the control arm (p = 0.59), and presence of PTS (Villalta >4) was 29.7% in the rosuvastatin arm vs. 25.5% in the control arm (p = 0.41). Secondary analyses showed no difference between trial arms for presence of severe PTS at Day 180 (2.0% vs. 2.7%, p = 1) and for changes in Villalta score between baseline and Day 180 (-3.7 ± 4.4 vs. -4.0 ± 5.0, p = 0.59).

CONCLUSION

This randomized controlled pilot trial did not demonstrate efficacy of rosuvastatin to reduce Villalta score. Further studies with longer duration of exposure to rosuvastatin are needed.

TRIAL REGISTRATION

ClinicalTrials.gov, number NCT02679664.

摘要

背景

血栓形成后综合征（PTS）是静脉血栓栓塞症（VTE）最常见的并发症之一，会导致相当高的发病率和成本。除了适当的抗凝治疗外，没有药物或医疗干预措施有助于预防PTS。我们进行了一项多中心随机对照试验，以确定瑞舒伐他汀是否能预防PTS。

方法

312例新诊断为VTE并接受标准抗凝治疗的患者被随机分配，一组每天一次服用20mg瑞舒伐他汀辅助治疗180天（n = 155），另一组不服用瑞舒伐他汀（n = 157）。在最后一次研究访视时（第180±21天），一位对研究治疗不知情的独立观察者使用Villalta量表进行PTS评估。该试验的主要临床结局是第180天的平均Villalta评分。我们还探讨了第180天Villalta评分>4所定义的PTS的存在情况。患者的平均年龄为46.7±10.8岁，55.8%为女性。

结果

在第180天，瑞舒伐他汀组的Villalta评分为3.5±0.3，而对照组为3.3±0.3（p = 0.59）；瑞舒伐他汀组PTS（Villalta>4）的发生率为29.7%，对照组为25.5%（p = 0.41）。二次分析显示，试验组在第180天严重PTS的存在情况（2.0%对2.7%，p = 1）以及基线至第180天Villalta评分的变化（-3.7±4.4对-4.0±5.0，p = 0.59）方面没有差异。