Dabigatran and rivaroxaban in the patients with atrial fibrillation and venous thrombembolism: our first clinical experience
Abstract
ABSTRACT
Background: The new oral anticoagulant drugs (NOAC) have shown promising results in the randomized trials in patients with atrial fibrillation (AF) and venous thromboembolism (VTE). The aim of this study was to assess the efficacy and safety of NOAK in the clinical practice.
Methods: We included 1.215 patients, 914 with AF and 301 with VTE, who started NOAC. Data on the management and complications were obtained from the computer program Trombo.
Results: Patients with AF were treated with either dabigatran 2x110 mg or 2x150 mg or rivaroxaban 1x15 or 1x20 mg and followed for approximately 6 months. Patients with VTE were treated with rivaroxaban and followed for approximately 4 months. Regarding the NOAC prescribed, there was 21–26% of minor bleeding, 1,2–1,9% of major bleeding and 0,4–0,9% of thromboembolic events in patients with AF. In patients with VTE, 13% of minor and 1% of major bleeding, and 0,3% recurrent VTE were observed. There was 154 periprocedural management of patients with AF on NOACs, 3 patients suffered bleeding (all after polypectomy) and 1 patient suffered thromboembolic event postoperatively. NOAC discontinuation due to adverse events or complication was as expected in treatment with rivaroxaban and higher than expected in treatment with dabigatran.
Conclusions: Our first analysis of NOAC use in clinical practice showed acceptable safety and efficacy. Additional measures and cautions will be needed for treatment interruption during surgical procedures and complications.
Downloads
References
LITERATURA
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al; the RE-LY Steering Committee and Investigators. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009; 361: 1139–51.
Hohnloser SH, Oldgren J, Yang S, Wallentin L, Ezekowitz M, Reilly P, et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation 2012; 125: 669–76.
Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med 2012; 172: 397–402.
Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, et al. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 2011;123: 2363–72.
Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883–91.
Fox KA, Piccini JP, Wojdyla D, Becker RC, Halperin JL, Nessel CC, et al. Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J 2011; 32: 2387–94.
EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499–510.
EINSTEIN–PE Investigators, Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287–97.
Mavri A (ur.). Priročnik za uporabo novih peroralnih antikoagulacijskih zdravil v klinični praksi. 1. izd. Ljubljana: Slovensko zdravniško društvo, Sekcija za antikoagulacijsko zdravljenje in preprečevanje trombemboličnih bolezni pri Združenju za žilne bolezni, 2012.
Mavri A. Antikoagulacijsko zdravljenje, navodila bolniku. Ljubljana: Sekcija za antikoagulacijsko zdravljenje in preventivo trombemboličnih bolezni, Slovensko zdravniško društvo; 2012.
Kramarič A, Mavri A. Pomen nove oblike pisnega navodila za bolnike z antikoagulacijskim zdravljenjem. Zdrav Vestn 2009; 78: 445–50.
Banović S, Plut S, Mavri A, Štabuc B. Priporočila za endoskopske gastroenterološke posege in ukrepanje ob krvavitvah pri bolnikih, ki prejemajo nova peroralna antikoagulacijska zdravila. V: Fras Z, Poredoš P (ur.). Zbornik prispevkov 55. Tavčarjevi dnevi, Porotorož, 7. –9. november 2013. Zbornik prispevkov. Ljubljana: Medicinska fakulteta, Katedra za interno medicino, 2013, 51–6.
The Author transfers to the Publisher (Zdravniški vestnik/Slovenian Medical Journal) all economic copyrights following form Article 22 of the Slovene Copyright and Related Rights Act (ZASP), including the right of reproduction, the right of distribution, the rental right, the right of public performance, the right of public transmission, the right of public communication by means of phonograms and videograms, the right of public presentation, the right of broadcasting, the right of rebroadcasting, the right of secondary broadcasting, the right of communication to the public, the right of transformation, the right of audiovisual adaptation and all other rights of the author according to ZASP.
The aforementioned rights are transferred non-exclusively, for an unlimited number of editions, for the term of the statutory
The Author can make use of his work himself or transfer subjective rights to others only after 3 months from date of first publishing in the journal Zdravniški vestnik/Slovenian Medical Journal.
The Publisher (Zdravniški vestnik/Slovenian Medical Journal) has the right to transfer the rights, acquired parties without explicit consent of the Author.
The Author consents that the Article be published under the Creative Commons BY-NC 4.0 (attribution-non-commercial) or comparable licence.
