Statins could provide a safe, efficacious prophylaxis alternative for venous thromboembolism (VTE), according to results from a study published in the Journal of Thrombosis and Haemostasis.
Anticoagulant therapy is typically used in VTE prophylaxis, but it carries bleeding risks and concerns. Alternative therapies such as statins could provide efficacious prophylaxis while minimizing bleeding risks.
In the prospective, open label, randomized Statins Reduce Thrombophilia (START) trial (ClinicalTrials.gov identifier: NCT01613794), patients were withdrawn from anticoagulants and randomly assigned to receive rosuvastatin (126 patients) at 20 mg per day for 4 weeks or no intervention (119 patients) between December 2012 and December 2016.
Mean age of the patients was 58 years, and 61% were men. The researchers found that unprovoked VTE had occurred in 49% of the patients and 75% had cardiovascular risk factors.
Assessment of plasma samples taken at baseline and the end of the study using a thrombin generation assay showed that endogenous thrombin potential decreased in the rosuvastatin arm (mean, -24.94 nM*min; 95% confidence interval [CI], -71.81 to 21.93) and increased from baseline in the nonintervention arm (mean, 97.22 nM*min; 95% CI, 40.92 to 153.53). The average difference in endogenous thrombin potential between arms was -120.24 nM*min (95% CI, -192.97 to -47.51), which represented a 10.4% decrease in endogenous thrombin potential by rosuvastatin.
Thrombin peak increased in both the rosuvastatin group (mean 8.41 nM; 95% CI, -0.86 to 17.69) and the nonintervention group (mean 20.69 nM; 95% CI, 9.80 to 31.58). The average difference in peak change between treatment groups was -11.88 nM (95% CI, -26.11 to 2.35), which represented a 5% decrease in peak reduction by rosuvastatin.
Other parameters of thrombin generation did not change significantly. The decrease in endogenous thrombin potential and peak in the rosuvastatin arm was particularly pronounced in subgroups with cardiovascular risk factors and with unprovoked VTE.
“These results of the START trial suggest that statin therapy might be beneficial in patients at risk of recurrent VTE and provide a clinical rationale for the conduction of a randomized controlled trial to evaluate the effectiveness of rosuvastatin in decreasing the risk of recurrent VTE,” concluded the authors.
1. Orsi FA, Biedermann JS, Kruip MJ, et al. Rosuvastatin use reduces thrombin generation potential in patients with venous thromboembolism: a randomized controlled trial [published online December 19, 2018]. J Thromb Haemost. doi: 10.1111/jth.14364