Ривароксабан: двухлетний опыт применения в терапии острого венозного тромбоза
Хирургия
Дата публикации: августа 5, 2015
Ключевые слова
венозный тромбоз
легочная эмболия
лечение
антикоагулянтная терапия
ривароксабан
venous thrombosis
pulmonary embolism
treatment
anticoagulant therapy
Rivaroxabanum
легочная эмболия
лечение
антикоагулянтная терапия
ривароксабан
venous thrombosis
pulmonary embolism
treatment
anticoagulant therapy
Rivaroxabanum
Как цитировать
Баринов В., Счастливцев И., Лобастов К., Цаплин С., Баринова И., Каленова И. Ривароксабан: двухлетний опыт применения в терапии острого венозного тромбоза // КРЕМЛЕВСКАЯ МЕДИЦИНА<br><i>клинический вестник</i>. 2015. Т. № 2.
Аннотация
Цель исследования: оценить эффективность и безопасность пролонгированной антикоагулянтной терапии ве-нозного тромбоза (ВТ) оральным антикоагулянтом Ривароксабан.Материалы и методы. Проведено проспективное обсервационное исследование с включением пациентов, го-спитализированных в отделение сосудистой хирургии «Клиническая больница №1» УД Президента РФ с инструмен-тально верифицированным острым ВТ. Всем пациентам после подтверждения диагноза проводилась инициальная те-рапия низкомолекулярными гепаринами в течение 24–48 ч с последующим переводом на оральный антикоагулянт Ри-вароксабан в дозе 15 мг 2 р/сут на протяжении 3 нед с дальнейшим переходом на однократный приемом дозы 20 мг.Длительность терапии зависела от локализации и характера тромбоза и составляла от 3 до 12 мес и более. Конечны-ми точками исследования были развитие инструментально верифицированного рецидива венозных тромбоэмболийили геморрагических осложнений.Всего в исследование включено 103 пациента в возрасте 25–91 года (средний возраст 61,3±15,8 года), из них 44мужчины, 59 женщин, имевших от 0 до 6 индивидуальных факторов риска (в среднем 2,5±1,7). В 36,9% случаев тром-боз был спровоцирован известными обратимыми факторами, а в 63,1% являлся «идиопатическим». Проксимальный ВТнаблюдали у 65 пациентов, дистальный – у 38.Результаты. Рецидив ВТ был выявлен у 1 пациента (0,97%, 95% ДИ: 0,17–5,29%). Кумулятивная частота раз-вития геморрагических осложнений составила 11,65% (95% ДИ 6,79–19,27%), из которых 7,77% (95% ДИ 3,99–14,59%) – малые осложнения, не потребовавшие обращения к врачу и отмены препарата, и 3,88% (95% ДИ 1,52–9,56%) – клинически значимые, потребовавшие внепланового визита к врачу, прекращения терапии или медицинско-го вмешательства. Больших кровотечений выявлено не было. При этом все геморрагические осложнения были зареги-стрированы в первые 6 мес терапии.Заключение. Проведенное исследование продемонстрировало эффективность и безопасность активного при-менения нового орального антикоагулянта Ривароксабан в лечении ВТ, в том числе при длительности терапии более12 мес.Materials and methods. A prospective observational study has been performed in the department of vascular surgeryin the Clinical Hospital No1 subordinate to the Affair Management Department of the President of Russian Federation.Patients hospitalized to this department with verified diagnosis of acute venous thrombosis were included into the study.After the diagnosis confirmation all patients had an initial therapy with low-molecular heparins during 24–48 hours and thenwith oral anticoagulator Rivaroxabanum. Initially, this drug was administered in the dosage 15 mg twice a day during 3weeks; then, it was administered in the dosage 20 mg once a day. The therapy duration depended on thrombus location andseverity and lasted from 3 up to 12 months. The end-points of the study were to define the development of instrumentallyverified recurrences of venous thromboembolism or hemorrhagic complications.103 patients aged 25–91 (average age 61.3±15.8) ( 44 men, 59 women) who had from 0 to 6 individual risk factors (average 2.5±1.7) were included into the study. In 36.9% of cases thrombosis was triggered by the known reversible factors,while in 63.1% it was "idiopathic". Proximal venous thrombosis (VT) was seen in 65 patients; distal VT - in 38.Results. Recurrence of venous thrombosis was detected in one patient (0.97%, 95% CI: 0,17–5.29%). The cumulativeincidence of hemorrhagic complications was 11.65% (95% CI: 6.79–19.27% ) : 7.77% (95% CI: 3.99–14.59%) outof them were minor complications which did not need any specialist consultation and drug withdrawal; 3.88% (95% CI:1.52–9.56%) were clinically significant which needed an unscheduled visit to the doctor, discontinuation of the prescribedtherapy or medical intervention. There were no any serious bleedings. Moreover, all bleeding complications were registeredwithin the first six months of therapy.Conclusion. This study has demonstrated the efficacy and safety of active administration of new oral anticoagulantRivaroxabanum in patients with venous thrombosis including long-term therapy, up to 12 months.Литература
1. Савельев В.С., Чазов Е.И., Гусев Е.И., Кириенко А.И.
Российские клинические рекомендации по диагностике, лече-
нию и профилактике венозных тромбоэмболических осложне-
ний. Флебология. 2010; 1 (2): 5–6.
2. Chiquette E., Amato M.G., Bussey H.I. Comparison of an
anticoagulation clinic with usual medical care. Arch. Int. Med.
1998; 158: 1641–1647.
3. Cushman M., Tsai A.W., White R.H. et al. Deep vein
thrombosis and pulmonary embolism in two cohorts: the longitudinal
investigation of thromboembolism etiology. Am. J. Med. 2004; 117
(1): 19–25.
4. EINSTEIN Investigators. Oral rivaroxaban for symptoma
tic venous thrombo-embolism. N. Engl. J. Med. 2010; 363 (26):
2499–2510.
5. Guyatt G.H., Akl E.A., Crowther M. et al. American College
of Chest Physicians Antithrombotic Therapy and Prevention of
Thrombosis Panel. Executive summary: Antithrombotic Therapy
and Prevention of Thrombosis, 9th ed: American College of Chest
Physicians Evidence-Based Clinical Practice Guidelines. Chest.
2012; 141 (2, Suppl.): 7S–47S.
6. Hippisley-Cox J., Coupland C. Development and validation
of risk prediction algorithm (QThrombosis) to estimate future risk
ofvenous thromboembolism: prospective cohort study. Br. Med. 2011;
343: d4656.
7. Hutten B.A., Prins M.H. Duration of treatment with vitamin
K antagonists in symptomatic venous thromboembolism. Cochrane
Database Syst. Rev. 2000; (3): CD001367.
8. Middeldorp S., Prins M.H., Hutten B.A. Duration of
treatment with vitamin K antagonists in symptomatic venous
thromboembolism. Cochrane Database Syst. Rev. 2014; 8:
CD001367. doi: 10.1002/14651858.CD001367.pub3.
9. Naess I.A., Christiansen S.C., Romundstad P. et al. Incidence
and mortality of venous thrombosis: a population-based study. J.
Thromb. Haemost. 2007; 5 (4): 692–699.
10. Poli D., Antonucci E., Testa S. et al. Bleeding risk in very
old patients on Vitamin K antagonist treatment. Circulation. 2011;
124: 824–829.
11. Prandoni P., Noventa F., Ghirarduzzi A. et al. The
risk of recurrent venous thromboembolism after discontinuing
anticoagulation in patients with acute proximal deep vein thrombosis
or pulmonary embolism. A prospective cohort study in 1,626 patients.
Haematologica. 2007; 92 (2): 199–205.
12. Søgaard, K.K., Schmidt M., Pedersen L. et al. 30-year
mortality following venous thromboembolism: a population-based
cohort study. Circulation. 2014. CIRCULATIONAHA-114.
http://circ.ahajournals.org/content/early/2014/06/26/
CIRCULATIONAHA.114.009107.
13. Spencer F.A., Emery C., Lessard D. et al. The Worcester
Venous Thromboembolism study: a population-based study of the
clinical epidemiology of venous thromboembolism. J. Gen. Intern.
Med. 2006; 21: 722–727.
14. Wilson S.J., Wells P.S., Kovacs M.J. et al. Comparing the
quality of oral anticoagu- lant management by anticoagulation clinicsand
by family physicians: a randomized controlled trial. CMAJ.
2003; 169: 293–298.
15. Witt D.M., Sadler M.A., Shanahan R.L. et al. Effect of a
central- ized clinical pharmacology anticoagula- tion service on the
outcomes of anticoagulation therapy. Chest. 2005; 127: 1515–1522.
Российские клинические рекомендации по диагностике, лече-
нию и профилактике венозных тромбоэмболических осложне-
ний. Флебология. 2010; 1 (2): 5–6.
2. Chiquette E., Amato M.G., Bussey H.I. Comparison of an
anticoagulation clinic with usual medical care. Arch. Int. Med.
1998; 158: 1641–1647.
3. Cushman M., Tsai A.W., White R.H. et al. Deep vein
thrombosis and pulmonary embolism in two cohorts: the longitudinal
investigation of thromboembolism etiology. Am. J. Med. 2004; 117
(1): 19–25.
4. EINSTEIN Investigators. Oral rivaroxaban for symptoma
tic venous thrombo-embolism. N. Engl. J. Med. 2010; 363 (26):
2499–2510.
5. Guyatt G.H., Akl E.A., Crowther M. et al. American College
of Chest Physicians Antithrombotic Therapy and Prevention of
Thrombosis Panel. Executive summary: Antithrombotic Therapy
and Prevention of Thrombosis, 9th ed: American College of Chest
Physicians Evidence-Based Clinical Practice Guidelines. Chest.
2012; 141 (2, Suppl.): 7S–47S.
6. Hippisley-Cox J., Coupland C. Development and validation
of risk prediction algorithm (QThrombosis) to estimate future risk
ofvenous thromboembolism: prospective cohort study. Br. Med. 2011;
343: d4656.
7. Hutten B.A., Prins M.H. Duration of treatment with vitamin
K antagonists in symptomatic venous thromboembolism. Cochrane
Database Syst. Rev. 2000; (3): CD001367.
8. Middeldorp S., Prins M.H., Hutten B.A. Duration of
treatment with vitamin K antagonists in symptomatic venous
thromboembolism. Cochrane Database Syst. Rev. 2014; 8:
CD001367. doi: 10.1002/14651858.CD001367.pub3.
9. Naess I.A., Christiansen S.C., Romundstad P. et al. Incidence
and mortality of venous thrombosis: a population-based study. J.
Thromb. Haemost. 2007; 5 (4): 692–699.
10. Poli D., Antonucci E., Testa S. et al. Bleeding risk in very
old patients on Vitamin K antagonist treatment. Circulation. 2011;
124: 824–829.
11. Prandoni P., Noventa F., Ghirarduzzi A. et al. The
risk of recurrent venous thromboembolism after discontinuing
anticoagulation in patients with acute proximal deep vein thrombosis
or pulmonary embolism. A prospective cohort study in 1,626 patients.
Haematologica. 2007; 92 (2): 199–205.
12. Søgaard, K.K., Schmidt M., Pedersen L. et al. 30-year
mortality following venous thromboembolism: a population-based
cohort study. Circulation. 2014. CIRCULATIONAHA-114.
http://circ.ahajournals.org/content/early/2014/06/26/
CIRCULATIONAHA.114.009107.
13. Spencer F.A., Emery C., Lessard D. et al. The Worcester
Venous Thromboembolism study: a population-based study of the
clinical epidemiology of venous thromboembolism. J. Gen. Intern.
Med. 2006; 21: 722–727.
14. Wilson S.J., Wells P.S., Kovacs M.J. et al. Comparing the
quality of oral anticoagu- lant management by anticoagulation clinicsand
by family physicians: a randomized controlled trial. CMAJ.
2003; 169: 293–298.
15. Witt D.M., Sadler M.A., Shanahan R.L. et al. Effect of a
central- ized clinical pharmacology anticoagula- tion service on the
outcomes of anticoagulation therapy. Chest. 2005; 127: 1515–1522.