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Post-thrombotic syndrome in patients treated with rivaroxaban or enoxaparin/vitamin K antagonists for acute deep-vein thrombosis. A post-hoc analysis.
- Source :
-
Thrombosis and haemostasis [Thromb Haemost] 2016 Sep 27; Vol. 116 (4), pp. 733-8. Date of Electronic Publication: 2016 Sep 01. - Publication Year :
- 2016
-
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.
- Subjects :
- Adult
Aged
Female
Follow-Up Studies
Humans
Male
Middle Aged
Recurrence
Survival Analysis
Treatment Outcome
Vitamin K antagonists & inhibitors
Anticoagulants therapeutic use
Enoxaparin therapeutic use
Postthrombotic Syndrome epidemiology
Rivaroxaban therapeutic use
Venous Thrombosis drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 2567-689X
- Volume :
- 116
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Thrombosis and haemostasis
- Publication Type :
- Academic Journal
- Accession number :
- 27583311
- Full Text :
- https://doi.org/10.1160/TH16-01-0041