AI Article Synopsis
- Post-thrombotic syndrome (PTS) is a common complication after venous thromboembolism (VTE) that lacks effective preventive treatments aside from anticoagulation, prompting a study to test if rosuvastatin could be helpful.
- In a randomized controlled trial with 312 patients, participants received either 20 mg of rosuvastatin daily or no treatment while on standard anticoagulation for 180 days, with their PTS evaluated using the Villalta scale.
- The results showed no significant difference in PTS between the rosuvastatin group and the control group, indicating that rosuvastatin does not effectively reduce PTS, and further research is needed for potential long-term effects.
Article 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.
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Source |
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| http://dx.doi.org/10.1016/j.thromres.2022.03.014 | DOI Listing |
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