Background: Post-thrombotic syndrome (PTS) is one of the most frequent complication of venous thromboembolism (VTE). It has been postulated that rosuvastatin could prevent PTS via inhibiting expression of thrombus-associated mediators of inflammation.

Aims: To explore in a multicenter randomized controlled trial if generic 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 end of the trial, an independent observer who was blinded to study treatment performed a PTS assessment on each patient using the Villalta scale. The primary clinical outcomes were mean Villalta score and presence of PTS defined by Villalta score >4 at Day 180.  

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 was in 29.7% 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 (Villalta score ≥ 15) 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).

Conclusions: This randomized controlled trial did not demonstrate efficacy of short-term use of rosuvastatin to prevent PTS. Future studies with longer rosuvastatin treatment are needed to exclude any benefit in preventing PTS. (NCT02679664)

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/statins-for-venous-event-reduction-in-patients-with-venous-thromboembolism-a-multicenter-randomized-controlled-pilot-trial-with-a-focus-on-prevention-of-post-thrombotic-syndrome/