Abstract
Background
In this article, we report the outcomes of patients with deep venous thrombosis in
the lower limbs treated with the oral anticoagulant rivaroxaban or warfarin, focusing
on the recanalization rate (measured with duplex ultrasound) and the incidence of
postthrombotic syndrome.
Methods
This was a prospective, consecutive, randomized, blind cohort study of patients admitted
with deep venous thrombosis to the Division of Vascular and Endovascular Surgery,
Hospital do Servidor Público Estadual, São Paulo, Brazil, between March 2016 and July
2018. The patients were randomized into 2 groups and treated with oral anticoagulation
for 6 months: either rivaroxaban (group 1) or warfarin (group 2). The study was registered
at clinicaltrials.gov under NCT 02704598.
Results
Eighty-eight patients with deep venous thrombosis were admitted to the Vascular Surgery
Department and randomized into the 2 groups. The follow-up time was 360 days. Analyses
were performed at 180 and 360 days. Four patients were excluded from the study during
follow-up because of a diagnosis of ovarian cancer (1 patient), head and neck cancer
(1 patient), lung cancer (1 patient), and stomach cancer (1 patient). Therefore, 84
patients were evaluated: 46 patients in group 1 and 38 in group 2. The incidence of
postthrombotic syndrome was 17.9% (15 cases) in the total cohort, but was significantly
higher in group 2 (11 cases, 28.9%) than in group 1 (4 cases, 8.7%; P < .001; odds ratio, 4.278). The rate of total venous recanalization at 360 days was 40.5%
(34 patients) in the total cohort, but was significantly higher in group 1 (35 patients,
76.1%) than in group 2 (5 patients, 13.2%; P < .001). The incidence of partial venous recanalization was 46.4% and was significantly
higher in group 2 (28 patients, 73.7%) than in group 1 (11 patients, 23.9%; P = .016). Five patients in the total cohort (6%) showed no venous recanalization, all
of them in group 2 (P = .016).
Conclusion
In this study, patients who received oral rivaroxaban displayed a lower incidence
of postthrombotic syndrome and a better total vein recanalization rate after 6 and
12 months than patients who received warfarin.
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Article info
Publication history
Published online: July 02, 2019
Accepted:
May 25,
2019
Identification
Copyright
© 2019 Elsevier Inc. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- On the questionable ethics of randomizing patients with acute DVT to receive rivaroxaban or warfarinSurgeryVol. 167Issue 2
- PreviewI read with interest the recently published article on the comparison between a novel direct oral anticoagulant (rivaroxaban) and a vitamin K antagonist (warfarin) for the treatment of patients with acute deep vein thrombosis (DVT) of the lower extremities.1 In spite of the relatively low number of recruited patients, it provides strong evidence in support of rivaroxaban over warfarin for the prevention of post-thrombotic syndrome in patients with acute DVT.
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