Efficacy and safety of oral anticoagulant Rivaroxaban in patients after implantation of a cava filter

Schastlivtsev I.V.^1,2, Lobastov K.V.^1,2, Barinov V.E.^1,2, Boyarintsev V.V.¹

1) Clinical Hospital No 1 (Volynskaya) of the Administration of the RF President’s Affairs,
2) Chair of General Surgery of the Therapeutic Department, Russian National Research Medical University named after N.I. Pirogov, Moscow, Russia

Objective: preliminary assessment of efficacy and safety of prolonged anticoagulant therapy with Rivaroxaban in patients after implantation of a cava filter.

Materials and methods. This prospective clinical study included a total of 30 patients presenting with thrombosis of deep veins of lower limbs of proximal localization with signs of flotation of the thrombus and free apex more than 4 cm in length. The patients received a temporal cava filter later on not removed for various reasons. After implantation of the cava filter the patients were given therapeutic doses of low molecular weight heparins during 48 hours followed by switching to standard therapy with vitamin K antagonists or to an alternative regimen of treatment with new anticoagulant Rivaroxiban (15 mg twice daily for the first three weeks, then 20 mg once daily during the whole period of follow up). Rivaroxoban (Study Group) was given to 15 patients (8 men and 7 women aged from 35 to 87 years, mean age 65.5±16.2) having from one to six (averagely 2.9±1.4) individual risk factors for the development of venous thrombosis. Each of them had a matching patient included in the control group, receiving conventional therapy with vitamin K antagonists and corresponding by age (±5 years), gender, and the total number of individual risk factors (± 1). The maximal duration of follow up amounted to 1 year.

Results. The cava filter according to the findings of ultrasound duplex scanning was patent during the whole follow-up period in 100% of patients in the both groups. No relapses of venous thromboembolic complications were registered in any patient. The cumulative frequency of the development of haemorrhagic complications amounted to 13% for the Study Group patients and to 20% for the Controls, with the differences being statistically significant. In the control group haemorrhagic complications were of more severe forms: one intracranial haemorrhage and two intracutaneous haemorrhages (in the Study group – one intracutaneous haemorrhage and one gingival haemorrhage.

Conclusion. The study showed possibilities and safely of using new oral anticoagulant Rivaroxaban in patients with the implanted cava filter. The obtained pilot findings require further confirmation in randomized clinical studies.

KEY WORDS: venous thrombosis, thromboembolic complications, pulmonary artery thromboembolism, cava filter, anticoagulant therapy, rivaroxaban, vitamin K antagonists.

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