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New oral anticoagulants bleeding

Arnaud Bisson, Alexandre Bodin, Nicolas Clementy, Anne Bernard, Dominique Babuty, Gregory Y H Lip, Laurent Fauchier
AIMS: We compared thromboembolic (TE) and bleeding risks in patients with atrial fibrillation (AF) according to the new 'Evaluated Heartvalves, Rheumatic or Artificial' (EHRA) valve classification. METHODS: Patients were divided into 3 categories: (i) EHRA type 1 corresponds to the previous 'valvular' AF patients, with either rheumatic mitral valve stenosis or mechanical prosthetic heart valves; (ii) EHRA type 2 includes AF patients with other valvular heart disease (VHD) and valve bioprosthesis or repair; and (iii) 'non-VHD controls' i...
March 7, 2018: International Journal of Cardiology
Flavia Mayer, Ursula Kirchmayer, Paola Coletta, Nera Agabiti, Valeria Belleudi, Giovanna Cappai, Mirko Di Martino, Sebastian Schneeweiss, Marina Davoli, Elisabetta Patorno
BACKGROUND: Real-time monitoring is used to the ends of postmarketing observational research on newly marketed drugs. We implemented a pilot near-real-time monitoring program on the test case of oral anticoagulants. Specifically, we evaluated the safety and effectiveness of direct oral anticoagulants compared to vitamin K antagonists in nonvalvular atrial fibrillation secondary prevention during 2013-2015 in the Lazio Region, Italy. METHODS AND RESULTS: A cohort study was conducted using a sequential propensity-score-matched new user parallel-cohort design...
March 10, 2018: Journal of the American Heart Association
Sakiko Miyazaki, Katsumi Miyauchi, Hidemori Hayashi, Ryota Tanaka, Shuko Nojiri, Tadashi Miyazaki, Masataka Sumiyoshi, Satoru Suwa, Yuji Nakazato, Takao Urabe, Nobutaka Hattori, Hiroyuki Daida
BACKGROUND: The management of atrial fibrillation (AF) has evolved with the development of direct oral anticoagulants (DOACs), but data on their clinical effectiveness and safety outside clinical trial settings are limited. METHOD: The RAFFINE registry is an observational, multicenter, prospective registry of Japanese patients with AF, designed to follow clinical events over 3 years. Patient enrollment was conducted from 2013 to 2015 at university hospitals, general hospitals, and private clinics to ensure inclusion of a broad spectrum of representative AF patients...
March 1, 2018: Journal of Cardiology
Francesco Marongiu, Doris Barcellona
Direct oral anticoagulants (DOACs) represent an innovation because they avoid periodic laboratory monitoring, and also reduce cerebral bleeding. An examination of the performance of DOACs versus warfarin in randomized clinical trials dedicated to atrial fibrillation would reveal the poor performance of warfarin because the percentage of major bleeding is always above 3%; however, the percentage of major bleeding is less than half of that when the management is done in anticoagulation clinics (ACs). Several years ago, a common opinion was that ACs would disappear as soon as DOACs enter the market...
March 2, 2018: Internal and Emergency Medicine
Maja Hellfritzsch, Lotte Rasmussen, Jesper Hallas, Anton Pottegård
INTRODUCTION: Knowledge on adverse effects (AEs) related to non-vitamin K antagonist oral anticoagulants (NOACs) in real-world populations is sparse. OBJECTIVE: Our objective was to identify signals of potential AEs in patients with atrial fibrillation (AF) initiating NOAC treatment using a hypothesis-free screening approach. METHODS: Using the nationwide Danish registries, we identified patients with AF initiating dabigatran, rivaroxaban, or apixaban between 2011 and 2015 (n = 50,627)...
March 1, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Xuefeng Hu, Ying Xiao, Chuan Yu, Yinglin Zuo, Wen Yang, Xinan Wang, Baohua Gu, Jing Li
Factor Xa (FXa) is a serine protease that plays key roles in linking the intrinsic and extrinsic coagulation pathways to the final common pathway. DJT06001 is an oral, highly specific and direct FXa inhibitor for the prevention and treatment of thromboembolic diseases. We characterized the compound in vitro and studied its in vivo activity in rat thrombosis models, as well as bleeding risk and Pharmacokinetics and Pharmacodynamics (PK/PD) relationship. DJT06001 inhibited free FXa with an inhibitory constant (Ki) of 0...
February 21, 2018: European Journal of Pharmacology
N M Vorobyeva
The article contains an outline of the 2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With Nonvalvular Atrial Fibrillation. This document considers in detail problems of necessity and safety of temporary interrupting of anticoagulation for the period of procedure, main principles of interruption and restarting anticoagulant therapy after procedure, indications to the transitional (bridging) therapy in the periprocedural period, as well as possible strategies of periprocedural management of patients in dependence of risk of bleeding and thromboembolic complications...
February 2018: Kardiologiia
Megan K Phelps, Tracy E Wiczer, H Paige Erdeljac, Kelsey R Van Deusen, Kyle Porter, Gary Philips, Tzu-Fei Wang
Introduction Low-molecular-weight heparins are the standard treatment for cancer-associated thrombosis. Recently, direct oral anticoagulants are a new option for thrombosis treatment; however, data supporting the use of direct oral anticoagulants for cancer-associated thrombosis are limited. Objectives The primary objective of this study was to determine the rate of recurrent cancer-associated thrombosis and major bleeding within 6 months of starting either low-molecular-weight heparin or direct oral anticoagulant for treatment of cancer-associated thrombosis...
January 1, 2018: Journal of Oncology Pharmacy Practice
B Kováčová, J Červeňová
Direct oral anticoagulants (DOACs) became rapidly accepted as an alternative to warfarin in the prevention of stroke in atrial fibrillation and prophylaxis of thromboembolic events. Their safety and efficacy have been well documented in several studies, however, as with any new drug, use in real-world population often reveals risk factors that may affect treatment outcomes. The aim of the study was to determine the prescribing patterns and analyse patient characteristics to identify incidence of selected factors (age, weight, comorbidities and interacting medication) that may affect DOAC safety and efficacy...
September 1, 2017: Die Pharmazie
Luiz Cláudio Rodrigues Pereira da Silva, Valerio Todaro, Flávia Almada do Carmo, Flavia Serra Frattani, Valeria Pereira de Sousa, Carlos Rangel Rodrigues, Plínio Cunha Sathler, Lucio Mendes Cabral
Fucoidan-loaded nanoparticles emerge as great candidates to oral anticoagulant therapy, due to increasing of bioavailability and circulation time of this natural anticoagulant. Crosslink between chitosan chains are performed using glutaraldehyde to confer higher gastric pH resistance to nanoparticle matrices. In this work, chitosan-fucoidan nanoparticles, without (NpCF) and with glutaraldehyde crosslink (NpCF 1% and NpCF 2%), were prepared to evaluate their anticoagulant, antithrombotic and hemorrhagic profile...
February 9, 2018: Nanotechnology
H M H Spronk, T Padro, J E Siland, J H Prochaska, J Winters, A C van der Wal, J J Posthuma, G Lowe, E d'Alessandro, P Wenzel, D M Coenen, P H Reitsma, W Ruf, R H van Gorp, R R Koenen, T Vajen, N A Alshaikh, A S Wolberg, F L Macrae, N Asquith, J Heemskerk, A Heinzmann, M Moorlag, N Mackman, P van der Meijden, J C M Meijers, M Heestermans, T Renné, S Dólleman, W Chayouâ, R A S Ariëns, C C Baaten, M Nagy, A Kuliopulos, J J Posma, P Harrison, M J Vries, H J G M Crijns, E A M P Dudink, H R Buller, Y M C Henskens, A Själander, S Zwaveling, O Erküner, J W Eikelboom, A Gulpen, F E C M Peeters, J Douxfils, R H Olie, T Baglin, A Leader, U Schotten, B Scaf, H M M van Beusekom, L O Mosnier, L van der Vorm, P Declerck, M Visser, D W J Dippel, V J Strijbis, K Pertiwi, A J Ten Cate-Hoek, H Ten Cate
Atherothrombosis is a leading cause of cardiovascular mortality and long-term morbidity. Platelets and coagulation proteases, interacting with circulating cells and in different vascular beds, modify several complex pathologies including atherosclerosis. In the second Maastricht Consensus Conference on Thrombosis, this theme was addressed by diverse scientists from bench to bedside. All presentations were discussed with audience members and the results of these discussions were incorporated in the final document that presents a state-of-the-art reflection of expert opinions and consensus recommendations regarding the following five topics: 1...
February 2018: Thrombosis and Haemostasis
P F Kravtsov, S E Katorkin, M A Melnicov
The urgency of the problem. The incidence of various thromboembolic complications in patients with oncopathology reaches 5-12%. When treating VTE in patients with oncology it is necessary to choose between two generally recognized alternatives. The recommended two-component scheme of the initiating phase of anticoagulant therapy with subsequent long-term admission of VKA is fraught with the development of clinically significant bleeding during the initial selection of the dose of warfarin and an increased risk of recurrence of VTE...
2018: Khirurgiia
Finlay A McAlister, Scott Garrison, Leanne Kosowan, Justin A Ezekowitz, Alexander Singer
BACKGROUND: As questions have been raised about the appropriateness of direct oral anticoagulant (DOAC) dosing among outpatients with atrial fibrillation, we examined this issue in patients being managed by primary care providers. METHODS AND RESULTS: This was a retrospective cohort new-user study using electronic medical records from 744 Canadian primary care clinicians. Potentially inappropriate DOAC prescribing was defined as prescribing lower or higher doses than those recommended by guidelines for patients with nonvalvular atrial fibrillation...
January 26, 2018: Journal of the American Heart Association
Martin Martinek, Marianne Gwechenberger, Daniel Scherr, Clemens Steinwender, Markus Stühlinger, Helmut Pürerfellner, Franz Xaver Roithinger, Lukas Fiedler
In summary, uninterrupted oral antikoagulation can be recommended, with different recommendation classes and levels of evidence, for both, VKA and NOAC therapy, in the framework of PVI. Even with low CHA2DS2 VASc scores, OAK is indicated 3-4 weeks before and 8 weeks after the procedure. Periinterventional bridging with heparins should be avoided due to increased bleeding events.The present Consensus provides recommendations on the current state of knowledge and has been prepared exclusively by members of the Rhythmology Working Group of the Austrian Cardiological Society who have great practical experience in catheter ablation and peri-interventional OAK in patients with atrial fibrillation...
January 25, 2018: Wiener Klinische Wochenschrift
Simone Y Loo, Janie Coulombe, Sophie Dell'Aniello, James M Brophy, Samy Suissa, Christel Renoux
OBJECTIVES: To evaluate the effectiveness and safety of novel oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) among patients with non-valvular atrial fibrillation (NVAF), particularly those with chronic kidney disease (CKD). DESIGN: Population-based matched cohort study. SETTING: Over 670 primary care practices in the UK, contributing to the Clinical Practice Research Datalink. PARTICIPANTS: Up to 6818 adult patients newly treated with NOACs between 2011 and 2016, matched 1:1 to new users of VKAs on age, sex and high-dimensional propensity score...
January 24, 2018: BMJ Open
Craig I Coleman, Tatsiana Vaitsiakhovich, Elaine Nguyen, Erin R Weeda, Nitesh A Sood, Thomas J Bunz, Bernhard Schaefer, Anna-Katharina Meinecke, Daniel Eriksson
BACKGROUND: Schemas to identify bleeding-related hospitalizations in claims data differ in billing codes used and coding positions allowed. We assessed agreement across bleeding-related hospitalization coding schemas for claims analyses of nonvalvular atrial fibrillation (NVAF) patients on oral anticoagulation (OAC). HYPOTHESIS: We hypothesized that prior coding schemas used to identify bleeding-related hospitalizations in claim database studies would provide varying levels of agreement in incidence rates...
January 23, 2018: Clinical Cardiology
Michela Giustozzi, Maria C Vedovati, Giancarlo Agnelli
: A high risk of venous thromboembolism (VTE) recurrence requires extended anticoagulation but limits the options to control heavy menstrual bleeding (HMB) in women of reproductive age. We report the management of HMB in a 48-year-old woman with a history of menometrorrhagia, recurrent VTE and multiple VTE risk factors. Due to the occurrence of HMB during extended rivaroxaban treatment, the presence of a uterine fibroid and the contraindication to interrupt anticoagulation for high risk of VTE recurrence, she received hormonal treatment first with a gonadotropin-releasing hormone agonist and then with progestin...
January 15, 2018: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
Scott G Garland, Christina E DeRemer, Steven M Smith, John G Gums
OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the factor Xa (FXa) inhibitor betrixaban for extended-duration prophylaxis of acute medically ill patients with venous thromboembolism (VTE) risk factors. DATA SOURCES: A MEDLINE/PubMed (January 1990 to October 2017) search was conducted using the following keywords: betrixaban, PRT054021, FXa inhibitor, novel oral anticoagulant, NOAC, direct oral anticoagulant, DOAC, and target specific oral anticoagulant, TSOAC...
January 1, 2018: Annals of Pharmacotherapy
Julieta Weirthein, Dennis Scolnik, Nili Yanai Milshtein, Tali Capua, Miguel Glatstein
Novel oral anticoagulants offer equivalent or improved therapeutic profiles compared with warfarin, with less risk of bleeding, no interactions with food, and no need for routine laboratory monitoring. Caution must be exercised in using these drugs in certain patient populations, for example, renal insufficiency, those receiving additional antithrombotic therapy, those with questionable compliance, children, and those with a high risk of gastrointestinal bleeding. One of the novel oral anticoagulants, rivaroxaban, is a direct Factor Xa inhibitor, used to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, deep vein thrombosis, and pulmonary embolism...
January 15, 2018: Pediatric Emergency Care
Pierre Fontana, Helia Robert-Ebadi, Françoise Boehlen, Marc Righini
New data support the fact that prophylactic anticoagulation with direct oral anticoagulants is effective and safe for the long-term prevention of venous thromboembolism. This type of treatment is dedicated for a subgroup of patients only, which is described in this article. With regard to major bleedings occurring with these anticoagulants, new data have been added to those already available for idarucizumab, a specific antagonist of dabigatran. Finally, we summarize the data regarding a breakthrough molecule, emicizumab, which could potentially open a new era in the management of people with haemophilia A...
January 10, 2018: Revue Médicale Suisse
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