Essentials The role of
statins in hemostasis and
venous thromboembolism (VTE) prophylaxis is not clear. This trial assessed whether
rosuvastatin use affects
thrombin generation in patients with VTE. Endogenous
thrombin potential and peak were decreased by 10% and 5% with
rosuvastatin therapy. These results provide basis for trials on the efficacy of
statins in reducing recurrent VTE risk. SUMMARY: Background
Statin therapy could form an alternative prophylactic treatment for
venous thromboembolism (VTE) if
statins are proven to downregulate hemostasis and prevent recurrent VTE, without increasing
bleeding risk. Objectives The
STAtins Reduce
Thrombophilia (START) trial investigated whether
statin affects coagulation in patients with prior VTE. Patients/methods After anticoagulation withdrawal, patients were randomized to
rosuvastatin 20 mg day-1 for 4 weeks or no intervention. Plasma samples taken at baseline and at the end of the study were analyzed employing
thrombin generation assay. Results and conclusions The study comprised 126
rosuvastatin users and 119 non-users. Mean age was 58 years, 61% were men, 49% had unprovoked VTE and 75% had cardiovascular (CV) risk factors. Endogenous
thrombin potential (ETP) increased from baseline to end of study in non-
statin users (mean 97.22 nm*min; 95% CI, 40.92-153.53) and decreased in
rosuvastatin users (mean -24.94 nm*min; 95% CI, -71.81 to 21.93). The mean difference in ETP change between treatments was -120.24 nm*min (95% CI, -192.97 to -47.51), yielding a 10.4% ETP reduction by
rosuvastatin. The
thrombin peak increased in both non-
statin (mean 20.69 nm; 95% CI, 9.80-31.58) and
rosuvastatin users (mean 8.41 nm; 95% CI -0.86 to 17.69). The mean difference in peak change between treatments was -11.88 nm (95% CI, -26.11 to 2.35), yielding a 5% peak reduction by
rosuvastatin. Other
thrombin generation parameters did not change substantially. The reduction in ETP and peak by
rosuvastatin was more pronounced in the subgroups of participants with CV risk factors and with unprovoked VTE. We conclude that
rosuvastatin reduces
thrombin generation potential in patients who had VTE.