Post‐thrombotic syndrome in patients with venous thromboembolism treated with dabigatran or warfarin: A long‐term cross‐sectional follow‐up of RE‐COVER study patients

Abstract

BackgroundStudies suggest that the direct factor Xa inhibitor rivaroxaban compared to warfarin reduces the risk of post‐thrombotic syndrome (PTS) after deep vein thrombosis (DVT), but this has not been evaluated for oral direct thrombin inhibitors. ObjectivesTo compare the long‐term prevalence of PTS, recurrent venous thromboembolism (VTE), and health‐related quality of life (HRQoL) in patients with acute DVT and/or pulmonary embolism (PE), randomized to treatment with dabigatran or warfarin in the phase III RE‐COVER studies. MethodsWe conducted a cross‐sectional follow‐up study of patients randomized in Canada, Norway, and Sweden. PTS was assessed by the patient‐reported Villalta scale (PRV) and HRQoL by EQ‐5D and VEINES‐QOL/Sym. ResultsWe included 349 patients between December 2015 and November 2018; 166 were treated with dabigatran and 183 with warfarin. DVT (+/− PE) was index event in 255 patients, whereas 94 patients had PE only. Mean time from index event was 8.7 (standard deviation 1.4) years. PTS was diagnosed in 63% of patients with DVT and in 46% of patients with PE only, and did not differ between the treatment groups; the crude odds ratio (OR) for PTS in patients treated with dabigatran compared with warfarin was 1.1 (95% confidence interval [CI] 0.6–1.8) after DVT and 1.2 (95% CI 0.5–2.6) after PE only. The prevalence of recurrent VTE was 21% in both treatment groups. HRQoL scores did not differ between groups. ConclusionIn this long‐term cross‐sectional study, the prevalence of PTS, recurrent VTE, and HRQoL were similar in patients treated with dabigatran and warfarin.