title: Post-thrombotic syndrome in patients treated with rivaroxaban or enoxaparin/vitamin K antagonists for acute deep-vein thrombosis. A post-hoc analysis.
abstract: Post-thrombotic syndrome (PTS) is a common complication of deep-vein thrombosis (DVT). Poor quality treatment with vitamin K antagonists (VKA) is a risk factor for PTS. We hypothesised that treatment with the direct oral anticoagulant (DOAC) rivaroxaban may lower PTS incidence as compared to enoxaparin/VKA, as DOACs have a more stable pharmacologic profile than VKA. We performed a post-hoc subgroup analysis of the Einstein DVT trial (n=3449). Kaplan-Meier survival analysis was performed to compare the cumulative incidence of PTS between the rivaroxaban and enoxaparin/VKA groups. Hazard ratios (HR) and 95 % confidence intervals (CI) were calculated using Cox proportional hazards models. We included 336 patients with a mean age of 58 ± 16 years and a median follow-up after index DVT of 57 months (interquartile range 48-64). Of these, 162 (48 %) had been treated with rivaroxaban and 174 (52 %) with enoxaparin/VKA. The cumulative PTS incidence at 60 months follow-up was 29 % in the rivaroxaban group and 40 % in the enoxaparin/VKA group. After adjusting for age, gender, body mass index, previous VTE, ipsilateral recurrent DVT, extent of DVT, idiopathic DVT, duration of anticoagulant treatment, compliance to assigned study medication, elastic compression stocking use and active malignancy, the HR of PTS development for rivaroxaban was 0.76 (95 % CI: 0.51-1.13). In conclusion, treatment of acute DVT with rivaroxaban was associated with a numerically lower but statistically non-significant risk of PTS compared to enoxaparin/VKA treatment. The potential effect on reducing PTS deserves evaluation in a large randomised trial.
authors: Y. W. Cheung, MD, Department of Vascular Medicine, F4-143, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands, Tel.: +31 20 5665976, Fax: +31 20 5669343, E-mail: y. w.cheung@amc.uva.nl.
authors: Y Whitney
authors: YW
authors: Cheung
authors: Saskia
authors: S
authors: Middeldorp
authors: Martin H
authors: MH
authors: Prins
authors: Akos F
authors: AF
authors: Pap
authors: Anthonie W A
authors: AW
authors: Lensing
authors: Arina J
authors: AJ
authors: Ten Cate-Hoek
authors: Sabina
authors: S
authors: Villalta
authors: Marta
authors: M
authors: Milan
authors: Jan
authors: J
authors: Beyer-Westendorf
authors: Peter
authors: P
authors: Verhamme
authors: Rupert M
authors: RM
authors: Bauersachs
authors: Paolo
authors: P
authors: Prandoni
mesh_terms: D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D017984:Enoxaparin / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D054070:Postthrombotic Syndrome / Q000453:epidemiology*; D012008:Recurrence; D000069552:Rivaroxaban / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy*; D014812:Vitamin K / Q000037:antagonists & inhibitors
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D014812:Vitamin K; D000069552:Rivaroxaban
keywords: Post-thrombotic syndrome; deep-vein thrombosis; rivaroxaban; vitamin K antagonists