Background: Statins may reduce the risk for recurrent venous thromboembolism (VTE), however, no randomized trials have explored this hypothesis.
Aims: To determine feasibility of recruitment of a larger trial of secondary VTE prevention with rosuvastatin.
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). Efficacy and safety clinical outcomes are summarized in Table 1.
|Thrombotic events, n (%)|
|Recurrent major VTE (total)||3 (1.9)||2 (1.3)||0.68|
|Recurrent DVT||1 (0.6)||0||0.50|
|Recurrent PE||2 (1.3)||2 (1.3)||1|
|Recurrent non-major VTE||1 (0.6)||0||0.50|
|Arterial events (total)||1 (0.6)||0||0.50|
|Acute limb ischemia||0||0||1|
|Death from any cause, n (%)||0||1 (0.6)||1|
|Major bleed, n (%)||0||1 (0.6)||1|
|Clinically relevant nonmajor bleeding, n (%)||2 (1.3)||1 (0.6)||1|
|Major muscle toxicity (CK>10ULN), n (%)||1 (0.6)||0||1|
|Muscle-related adverse events, n (%)||11 (7.1)||1 (0.6)||0.01|
Conclusions: In conclusion, this pilot trial established feasibility of a larger scale randomized controlled trial to determine the efficacy of adjuvant rosuvastatin for secondary prevention of VTE. (NCT02679664).
To cite this abstract in AMA style:Delluc A, Ghanima W, Kovacs M, Shivakumar S, Kahn S, Sandset PM, Kearon C, Rodger M. Statins for Venous Event Reduction in Patients with Venous Thromboembolism: A Randomized Controlled Pilot Trial Assessing Feasibility [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/statins-for-venous-event-reduction-in-patients-with-venous-thromboembolism-a-randomized-controlled-pilot-trial-assessing-feasibility/. Accessed November 29, 2023.
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