The Effects of 3-Month Rosuvastatin Adjuvant Therapy on Post Thrombotic Syndrome following Deep Vein Thrombosis; a Randomized Clinical Trial.

INTRODUCTION: Statins are known to have anticoagulation and anti-inflammatory effects. This study aimed to investigate the effect of Rosuvastatin in reduction of post thrombotic syndrome (PTS) following deep vein thrombosis (DVT).

METHODS: In this randomized clinical trial, patients who were diagnosed with DVT of lower extremity were randomly assigned to 4 treatment groups: group 1: Warfarin, group 2: Warfarin + Rosuvastatin, group 3: Rivaroxaban, and group 4: Rivaroxaban + Rosuvastatin. The treatments were followed for 3 months and prevalence of PTS (as primary outcome), as well as the changes in serum levels of D-dimer and C reactive protein (CRP), and the extent of thrombosis before and after the intervention (as secondary outcomes) were compared between groups.

RESULTS: 182 patients with the mean age of 55.22 ± 4.1 years finished the trial period (51.64% male). There was no significant difference between the groups regarding the baseline characteristics. Based on the Brandjes score, 31 (17.03%) patients had PTS at the end of the study. The occurrence of PTS was significantly lower in the groups taking statins (p<0.0001). Although the change in the mean difference of legs circumference before and after intervention, were significant in all groups (p < 0.05), the differences was more prominent in groups 2 and 4 (p < 0.0001). After 3 months of taking medication, decrease of CRP was more prominent in the statin groups (p = 0.001), and most cases with normal CRP were in statin groups. Among the patients with the serum D-dimer level above 10000 ng/mL, patients in the statin groups experienced significantly more reduction in D-dimer levels than the other groups (p<0.001).

CONCLUSION: Rosuvastatin administration in combination with rivaroxaban or warfarin significantly reduces the level of inflammatory factors including CRP and D-dimer, compared to patients receiving anticoagulants alone. Rosuvastatin administration can significantly reduce the incidence of PTS and cause a difference in the size of the lower limbs within 3 months.