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Rivaroxaban in ICH

David J Graham, Marsha E Reichman, Michael Wernecke, Ya-Hui Hsueh, Rima Izem, Mary Ross Southworth, Yuqin Wei, Jiemin Liao, Margie R Goulding, Katrina Mott, Yoganand Chillarige, Thomas E MaCurdy, Chris Worrall, Jeffrey A Kelman
Importance: Dabigatran and rivaroxaban are non-vitamin K oral anticoagulants approved for stroke prevention in patients with nonvalvular atrial fibrillation (AF). There are no randomized head-to-head comparisons of these drugs for stroke, bleeding, or mortality outcomes. Objective: To compare risks of thromboembolic stroke, intracranial hemorrhage (ICH), major extracranial bleeding including major gastrointestinal bleeding, and mortality in patients with nonvalvular AF who initiated dabigatran or rivaroxaban treatment for stroke prevention...
October 3, 2016: JAMA Internal Medicine
Craig I Coleman, Matthias Antz, Kevin Bowrin, Thomas Evers, Edgar P Simard, Hendrik Bonnemeier, Riccardo Cappato
BACKGROUND: Little data exists regarding the effectiveness and safety of rivaroxaban or apixaban versus warfarin in nonvalvular atrial fibrillation (NVAF) patients treated outside of clinical trials. METHODS: This was a retrospective study using MarketScan claims from January 2012 to October 2014. We included adults, newly initiated on rivaroxaban, apixaban or warfarin, with a baseline CHA2DS2-VASc score ≥2, ≥2 diagnosis codes for NVAF and ≥180 days of continuous medical and prescription benefits...
September 20, 2016: Current Medical Research and Opinion
Martin H Ellis, Tsipora Neuman, Haim Bitterman, Sari Greenberg Dotan, Ariel Hammerman, Erez Battat, John W Eikelboom, Jeffrey S Ginsberg, Jack Hirsh
BACKGOUND: Randomized controlled trials (RCTs) have shown that dabigatran, rivaroxaban and warfarin cause similar bleeding rates. METHODS: We performed a retrospective population-based cohort study to determine the incidence of bleeding in patients with atrial fibrillation (AF) beginning dabigatran, rivaroxaban or warfarin. Consecutive patients initiating anticoagulation for AF during a 3year period were identified using a computerized database. Patients who bled and required hospitalization underwent chart review...
September 2016: European Journal of Internal Medicine
Haruhiko Takahashi, Yasushi Jimbo, Hiroki Takano, Hiroshi Abe, Masahito Sato, Yukihiko Fujii, Yoshifusa Aizawa
The neuroradiological findings and its outcomes of intracerebral hemorrhage (ICH) were compared between the non-vitamin K antagonist oral anticoagulant (NOAC) therapy and warfarin therapy. In the latest 3 years, 13 cases of nonvalvular atrial fibrillation on NOAC therapy were admitted for ICH. For comparison, 65 age- and gender-comparable patients with ICH on warfarin therapy were recruited. Three NOACs had been prescribed: dabigatran (n = 4), rivaroxaban (n = 2), and apixaban (n = 7). The average ages were 76 ± 9 and 78 ± 8 years in the warfarin (n = 65) and NOAC groups (n = 13), respectively...
July 15, 2016: American Journal of Cardiology
Jamil R Dibu, Jonathan M Weimer, Christine Ahrens, Edward Manno, Jennifer A Frontera
BACKGROUND: Activated prothrombin complex concentrates factor eight inhibitor bypassing activity (FEIBA) has been recommended for reversing novel oral anticoagulants (NOAC) in the context of intracerebral hemorrhage (ICH), though few clinical studies report its use. METHODS: A prospective study of patients with spontaneous ICH was conducted from May 2013 to May 2015. Hospital complications including hemorrhage (gastrointestinal bleeding, anemia requiring transfusion, and surgical site bleeding) and thrombosis (pulmonary embolus, deep vein thrombosis, ischemic stroke, and myocardial infarction) were recorded...
June 2016: Neurocritical Care
Melanie Dittmeier, Peter Kraft, Michael K Schuhmann, Felix Fluri, Christoph Kleinschnitz
Stroke outcome is more favourable in patients receiving oral anticoagulants compared with non-anticoagulated patients. The reasons for this "stroke-attenuating" property of oral anticoagulants are largely unknown. This study examined whether prestroke anticoagulation with rivaroxaban, a novel direct factor Xa inhibitor, influences stroke severity, thrombin-mediated intracerebral thrombus formation and pro-inflammatory processes in a rat model of brain ischaemia/reperfusion injury. Male Wistar rats were anticoagulated with rivaroxaban and subjected to 90 minutes of transient middle cerebral artery occlusion...
April 2016: Thrombosis and Haemostasis
Satu Mustanoja, Tiina M Metso, Jukka Putaala, Noora Heikkinen, Elena Haapaniemi, Oili Salonen, Turgut Tatlisumak
BACKGROUND: Cervical artery dissection (CeAD) patients with or without stroke are frequently treated with either antiplatelet agents or vitamin K antagonists (VKAs), but few data are reported on the use of nonvitamin K oral anticoagulants (NOACs). METHODS: Between November 2011 and January 2014, we recorded data from patients with a stroke due to vertebral (VAD) or internal carotid artery dissection (ICAD). Patients using oral anticoagulants were included in the study and were divided into two treatment groups: patients using NOACs and those using VKAs...
August 2015: Brain and Behavior
Ramesh Grandhi, W Christopher Newman, Xiaoran Zhang, Gillian Harrison, Colleen Moran, David O Okonkwo, Andrew F Ducruet
OBJECTIVE: Direct factor Xa inhibitors rivaroxaban and apixaban are efficacious alternatives to warfarin and confer a lower risk of spontaneous intracranial hemorrhage (ICH); however, they lack a validated reversal strategy. We evaluated the efficacy and safety of 4-factor prothrombin complex concentrate (PCC) administration on rivaroxaban- and apixaban-mediated coagulopathy in patients with traumatic and spontaneous ICH. METHODS: Retrospective review of patients presenting with traumatic and spontaneous ICH and concurrent use of rivaroxaban or apixaban...
December 2015: World Neurosurgery
Boris Arbit, Jonathan C Hsu
Atrial fibrillation (AF) is the most common cardiac arrhythmia and predisposes patients to an increased risk of embolic stroke. After nearly 60 years, warfarin is no longer the only effective therapeutic option for patients with AF. Large randomized trials have consistently shown that non-vitamin K oral anticoagulants (NOACs) including dabigatran, rivaroxaban, apixaban, and edoxaban significantly reduce from the risk of intracranial hemorrhage (ICH) compared with warfarin. We provide a focused review regarding the NOACs and ICH in AF patients by summarizing findings of these large clinical trials, mechanisms of lower ICH, reversal strategies with specific agents, and monitoring strategies...
November 2015: Clinical Cardiology
Hisanao Akiyama, Kenji Uchino, Yasuhiro Hasegawa
OBJECTIVES: The first non-vitamin K antagonist oral anticoagulant (NOAC) introduced to the market in Japan was dabigatran in March 2011, and three more NOACs, rivaroxaban, apixaban, and edoxaban, have since become available. Randomized controlled trials of NOACs have revealed that intracranial hemorrhage (ICH) occurs less frequently with NOACs compared with warfarin. However, the absolute incidence of ICH associated with NOACs has increased with greater use of these anticoagulants, and we wanted to explore the incidence, clinical characteristics, and treatment course of patients with NOACs-associated ICH...
2015: PloS One
Rebbeca Grysiewicz, Philip B Gorelick
Warfarin, a vitamin K epoxide reductase inhibitor, is the oral anticoagulant most commonly used to reduce the risk of stroke in patients with atrial fibrillation (AF). Warfarin has proved to be efficacious for this purpose in multiple clinical trials. However, warfarin use is laborious and associated with an increased risk of intracranial hemorrhage (ICH). Various factors increase the risk of warfarin-related ICH, including older age, intensity of anticoagulation, hypertension, and history of cerebrovascular disease...
November 2014: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Joji Hagii, Hirofumi Tomita, Norifumi Metoki, Shin Saito, Hiroshi Shiroto, Hiroyasu Hitomi, Takaatsu Kamada, Satoshi Seino, Koki Takahashi, Yoshiko Baba, Satoko Sasaki, Takamitsu Uchizawa, Manabu Iwata, Shigeo Matsumoto, Tomohiro Osanai, Minoru Yasujima, Ken Okumura
BACKGROUND AND PURPOSE: Neuroradiological characteristics and functional outcomes of patients with intracerebral hemorrhage (ICH) during novel oral anticoagulant treatment were not well defined. We examined these in comparison with those during warfarin treatment. METHODS: The consecutive 585 patients with ICH admitted from April 2011 through October 2013 were retrospectively studied. Of all, 5 patients (1%) had ICH during rivaroxaban treatment, 56 (10%) during warfarin, and the other 524 (89%) during no anticoagulants...
September 2014: Stroke; a Journal of Cerebral Circulation
Manish K Kasliwal, Nicholas G Panos, Lorenzo F Munoz, Roham Moftakhar, Demetrius K Lopes, Richard W Byrne
The emergence of dabigatran, rivaroxaban and apixaban has changed the approach to anticoagulation for patients worldwide. Continued approval of novel oral anticoagulants (NOAC) for non-valvular atrial fibrillation and venous thromboembolism will result in increasing use of these medications over warfarin. Morbidity and mortality of anticoagulant related intracranial hemorrhage (ICH) is relatively high and there is concern that outcomes may be worse with NOAC as there is a lack of specific antidotes for these agents with a greater risk for hematoma expansion...
January 2015: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
Takeshi Okada, Taizen Nakase, Masahiro Sasaki, Tatsuya Ishikawa
BACKGROUND: It is controversial whether taking antiplatelet agents (APs) or anticoagulant agents (ACs) could influence clinical outcome after intracerebral hemorrhage (ICH). METHODS: We retrospectively investigated 557 ICH patients between September 2008 and August 2013. We reviewed patients' characteristics, hematoma volume, deterioration (hematoma expansion, surgical hematoma evacuation, or death), and clinical outcome in modified Rankin Scale. RESULTS: A total of 397 were classified as neither AP nor AC ("Nothing"), 81 as single AP (44 as aspirin [ASA], 22 as clopidogrel or ticlopidine [CLP/TIC], 7 as cilostazol, 8 as dual antiplatelet therapy), 43 as single AC (40 as warfarin, 2 as rivaroxaban, 1 as dabigatran), and 36 as both AP and AC (AP + AC)...
August 2014: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Graeme J Hankey, Susanna R Stevens, Jonathan P Piccini, Yuliya Lokhnygina, Kenneth W Mahaffey, Jonathan L Halperin, Manesh R Patel, Günter Breithardt, Daniel E Singer, Richard C Becker, Scott D Berkowitz, John F Paolini, Christopher C Nessel, Werner Hacke, Keith A A Fox, Robert M Califf
BACKGROUND AND PURPOSE: Intracranial hemorrhage (ICH) is a life-threatening complication of anticoagulation. METHODS: We investigated the rate, outcomes, and predictors of ICH in 14 264 patients with atrial fibrillation from Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Cox proportional hazards modeling was used. RESULTS: During 1...
May 2014: Stroke; a Journal of Cerebral Circulation
François Laliberté, Michel Cloutier, Winnie W Nelson, Craig I Coleman, Dominic Pilon, William H Olson, C V Damaraju, Jeffrey R Schein, Patrick Lefebvre
BACKGROUND: Rivaroxaban was shown to be effective in reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF) in a randomized controlled trial setting. OBJECTIVE: To assess real-world safety, effectiveness, and persistence associated with rivaroxaban and warfarin in nonvalvular AF patients. METHODS: Healthcare claims from Symphony Health Solutions' Patient Transactional Datasets from May 2011 to July 2012 were analyzed...
July 2014: Current Medical Research and Opinion
Shinya Goto, Aiko Tomita
Patients with acute coronary syndrome (ACS) usually receive acetylsalicylic acid plus an adenosine diphosphate (ADP) receptor inhibitor to reduce the long-term risk of recurrent events. However, patients receiving standard antiplatelet prophylaxis still face a substantial risk of recurrent events. Strategies involving 3 antithrombotic agents with different modes of action have now been tested. In Thrombin Receptor Antagonists for Clinical Event Reduction (TRA-CER), compared with standard care alone, bleeding complications including intracranial hemorrhage (ICH) were increased with the addition of vorapaxar, without efficacy benefit...
March 2014: Clinical Cardiology
Shinichiro Uchiyama, Masatsugu Hori, Masayasu Matsumoto, Norio Tanahashi, Shin-Ichi Momomura, Shinya Goto, Tohru Izumi, Yukihiro Koretsune, Mariko Kajikawa, Masaharu Kato, Hitoshi Ueda, Kazuma Iekushi, Satoshi Yamanaka, Masahiro Tajiri
BACKGROUND: The risk factors that have been identified for bleeding events with rivaroxaban are predominantly the same as those predicting thromboembolic ones in patients with atrial fibrillation (AF). Our aim was to determine the net clinical benefit (NCB) from the results of the J-ROCKET AF trial, in which rivaroxaban was compared with warfarin in Japanese patients with AF. METHODS: Two strategies were adopted to quantify the NCB. First, the NCB was calculated as the number of ischemic strokes avoided with anticoagulation minus the number of excess intracranial hemorrhage (ICH) with a weight of 1...
May 2014: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Saurav Chatterjee, Partha Sardar, Giuseppe Biondi-Zoccai, Dharam J Kumbhani
IMPORTANCE: Randomized studies have shown a decreased risk of intracranial hemorrhage (ICH) with use of novel oral anticoagulants (NOACs). However, it is unclear whether the magnitude of benefit is similar for all NOACs currently available. OBJECTIVE: To perform a systematic review and meta-analysis to quantitatively assess the rates of ICH within the framework of both conventional and Bayesian statistics. DATA SOURCES: The MEDLINE, CENTRAL, CINAHL, and EBSCO databases, supplemented with conference abstracts, were searched up to December 1, 2012, with no language restriction...
December 2013: JAMA Neurology
Claus Z Simonsen, Thorsten Steiner, Anna Tietze, Dorte Damgaard
Warfarin-related intracerebral hemorrhage carries a particularly high risk of neurologic deterioration and death because of a high rate of hematoma expansion of about 50%. Novel oral anticoagulants (NOACs)--apixaban, dabigatran, and rivaroxaban--have a significantly smaller risk of intracerebral hemorrhage (ICH). However, two facts make this situation complicated: First, the risk of hematoma expansion is unknown for NOACs. Second, there is no specific antidote for neither of the NOACs. We present a case that suggests that hematoma expansion may occur after NOAC-related ICH...
February 2014: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
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