Statins for venous event reduction in patients with venous thromboembolism: a multicentre randomized controlled pilot trial assessing feasibility.

Background Statins may reduce the risk for recurrent venous thromboembolism (VTE), however, no randomized trials have explored this hypothesis. We performed a pilot randomized trial to determine feasibility of recruitment for a larger trial of secondary VTE prevention with rosuvastatin. Material and methods Patients with a newly diagnosed symptomatic proximal deep vein thrombosis and/or pulmonary embolism, receiving standard anticoagulation, were randomly allocated to adjuvant rosuvastatin 20 mg once daily for 180 days or no rosuvastatin for 6 months. Results Between November 2016 and December 2019, 3391 patients were assessed for eligibility in 6 centres. Of these patients, 1347 (39.7%) were eligible and approached for participation in the trial and 312 (23.1%) were randomized. The mean rate of randomization was 8.2±4.3 patients per month. During follow-up, 5 recurrent VTE events were observed, 3 (1.9%) in the rosuvastatin group (2 pulmonary embolism, 1 deep vein thrombosis) and 2 (1.3%) in the control group (2 pulmonary embolism) (p=0.68). One major arterial event occurred in the rosuvastatin arm and none in the control arm (0.6% vs. 0%, p=0.50). Conclusion This pilot trial supports the feasibility of a larger scale randomized controlled trial to determine the efficacy of adjuvant rosuvastatin for the secondary prevention of VTE. NCT02679664.