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Rivaroxaban in ICH

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https://www.readbyqxmd.com/read/29723935/a-systematic-review-and-bayesian-network-meta-analysis-of-risk-of-intracranial-hemorrhage-with-direct-oral-anticoagulants
#1
Zachary Wolfe, Safi U Khan, Fahad Nasir, Charumathi Raghu Subramanian, Bradley Lash
BACKGROUND: The comparative risk of intracranial hemorrhage (ICH) among direct oral anticoagulants (DOACs) (dabigatran, rivaroxaban, apixaban, and edoxaban) remains unclear. OBJECTIVE: To determine the difference in risk of ICH between DOACs. METHODS: 17 randomized controlled trials (RCTs) were selected using PubMed/MEDLINE, EMBASE, CENTRAL (Inception - 31 December 2017). Estimates were reported as odds ratio (OR) with 95% credible interval (CR...
May 3, 2018: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29509959/factor-xa-inhibitors-versus-vitamin-k-antagonists-for-preventing-cerebral-or-systemic-embolism-in-patients-with-atrial-fibrillation
#2
REVIEW
Karsten Mh Bruins Slot, Eivind Berge
BACKGROUND: Factor Xa inhibitors and vitamin K antagonists (VKAs) are now recommended in treatment guidelines for preventing stroke and systemic embolic events in people with atrial fibrillation (AF). This is an update of a Cochrane review previously published in 2013. OBJECTIVES: To assess the effectiveness and safety of treatment with factor Xa inhibitors versus VKAs for preventing cerebral or systemic embolic events in people with AF. SEARCH METHODS: We searched the trials registers of the Cochrane Stroke Group and the Cochrane Heart Group (September 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (August 2017), MEDLINE (1950 to April 2017), and Embase (1980 to April 2017)...
March 6, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29397310/characteristics-of-symptomatic-intracerebral-hemorrhage-in-patient-receiving-direct-oral-anticoagulants-comparison-with-warfarin
#3
Masahito Kawabori, Yoshimasa Niiya, Motoyuki Iwasaki, Shoji Mabuchi, Hiroyuki Ozaki, Koji Matsubara, Kiyohiro Houkin
BACKGROUND: Direct oral coagulants (DOAC) have been shown to decrease the frequency of intracerebral hemorrhage (ICH) compared with warfarin. However, the precise characteristics, such as the size and locations of the hemorrhage, and outcome and onset time of ICH in patient taking DOAC are not fully elucidated. METHODS: We retrospectively analyzed the characteristics of symptomatic patients with ICH taking either DOAC or warfarin between January 2012 and December 2015...
May 2018: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
https://www.readbyqxmd.com/read/29394504/rivaroxaban-plasma-levels-in-acute-ischemic-stroke-and-intracerebral-hemorrhage
#4
David J Seiffge, Georg Kägi, Patrik Michel, Urs Fischer, Yannick Béjot, Susanne Wegener, Marialuisa Zedde, Guillaume Turc, Charlotte Cordonnier, Peter S Sandor, Gilles Rodier, Andrea Zini, Manuel Cappellari, Sabine Schädelin, Alexandros A Polymeris, David Werring, Sebastian Thilemann, Ilaria Maestrini, Eivind Berge, Christopher Traenka, Jochen Vehoff, Gian Marco De Marchis, Monika Kapauer, Nils Peters, Gaia Sirimarco, Leo H Bonati, Marcel Arnold, Philippe A Lyrer, Emmanuel De Maistre, Andreas Luft, Dimtrios A Tsakiris, Stefan T Engelter
OBJECTIVE: Information about rivaroxaban plasma level (RivLev) may guide treatment decisions in patients with acute ischemic stroke (AIS) and intracerebral hemorrhage (ICH) taking rivaroxaban. METHODS: In a multicenter registry-based study (Novel Oral Anticoagulants in Stroke Patients collaboration; ClinicalTrials.gov: NCT02353585) of patients with stroke while taking rivaroxaban, we compared RivLev in patients with AIS and ICH. We determined how many AIS patients had RivLev ≤ 100ng/ml, indicating possible eligibility for thrombolysis, and how many ICH patients had RivLev ≥ 75ng/ml, making them possibly eligible for the use of specific reversal agents...
March 2018: Annals of Neurology
https://www.readbyqxmd.com/read/29344007/four-factor-prothrombin-complex-concentrate-improves-thrombin-generation-and-prothrombin-time-in-patients-with-bleeding-complications-related-to-rivaroxaban-a-single-center-pilot-trial
#5
Bettina Schenk, Stephanie Goerke, Ronny Beer, Raimund Helbok, Dietmar Fries, Mirjam Bachler
Background: Direct oral anticoagulants (DOACs) pose a great challenge for physicians in life-threatening bleeding events. The aim of this study was to test the efficacy of reversing the DOAC rivaroxaban using four-factor PCC (prothrombin complex concentrate), a non-specific reversing agent. Methods: Patients with life-threatening bleeding events during rivaroxaban treatment were included and administered 25 U kg-1 of PCC. Blood samples were collected immediately prior to as well as after PCC treatment at predefined time intervals...
2018: Thrombosis Journal
https://www.readbyqxmd.com/read/29318683/prospective-surveillance-pilot-of-rivaroxaban-safety-within-the-us-food-and-drug-administration-sentinel-system
#6
Elizabeth A Chrischilles, Joshua J Gagne, Bruce Fireman, Jennifer Nelson, Sengwee Toh, Azadeh Shoaibi, Marsha E Reichman, Shirley Wang, Michael Nguyen, Rongmei Zhang, Rima Izem, Margie R Goulding, Mary Ross Southworth, David J Graham, Candace Fuller, Hannah Katcoff, Tiffany Woodworth, Catherine Rogers, Ryan Saliga, Nancy D Lin, Cheryl N McMahill-Walraven, Vinit P Nair, Kevin Haynes, Ryan M Carnahan
PURPOSE: The US Food and Drug Administration's Sentinel system developed tools for sequential surveillance. METHODS: In patients with non-valvular atrial fibrillation, we sequentially compared outcomes for new users of rivaroxaban versus warfarin, employing propensity score matching and Cox regression. A total of 36 173 rivaroxaban and 79 520 warfarin initiators were variable-ratio matched within 2 monitoring periods. RESULTS: Statistically significant signals were observed for ischemic stroke (IS) (first period) and intracranial hemorrhage (ICH) (second period) favoring rivaroxaban, and gastrointestinal bleeding (GIB) (second period) favoring warfarin...
March 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28974629/effectiveness-and-safety-of-non-vitamin-k-antagonist-oral-anticoagulants-in-asian-patients-with-atrial-fibrillation
#7
MULTICENTER STUDY
Myung-Jin Cha, Eue-Keun Choi, Kyung-Do Han, So-Ryoung Lee, Woo-Hyun Lim, Seil Oh, Gregory Y H Lip
BACKGROUND AND PURPOSE: There are limited real-world data comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) and warfarin in Asians with nonvalvular atrial fibrillation. We aimed to compare the effectiveness and safety between NOACs and warfarin users in the Korean atrial fibrillation population, with particular focus on high-risk patients. METHODS: Using the Korean National Health Insurance Service database, we analyzed the risk of ischemic stroke, intracranial hemorrhage (ICH) events, and all-cause death in NOAC users (n=11 611 total, n=5681 taking rivaroxaban, n=3741 taking dabigatran, and n=2189 taking apixaban) compared with propensity score-matched warfarin users (n=23 222) among patients with high-risk atrial fibrillation (CHA2 DS2 -VASc score ≥2) between 2014 and 2015...
November 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28862479/cost-effectiveness-analysis-of-dabigatran-versus-rivaroxaban-for-stroke-prevention-in-patients-with-non-valvular-atrial-fibrillation-using-real-world-evidence-in-elderly-us-medicare-beneficiaries
#8
Siyang Peng, Kristen A Deger, Anastasia Ustyugova, Pranav Gandhi, Nan Qiao, Cheng Wang, Anuraag R Kansal
OBJECTIVE: Dabigatran and rivaroxaban have been approved by the US FDA to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients. Newly published real-world evidence based on the US population found that elderly Medicare patients with NVAF treated with rivaroxaban experienced statistically significant increases in intracranial hemorrhage (ICH) and major extracranial bleeding, and statistically nonsignificant decreases in thromboembolic stroke and acute myocardial infarction (AMI) compared with dabigatran...
January 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28835439/management-of-rivaroxaban-or-apixaban-associated-major-bleeding-with-prothrombin-complex-concentrates-a-cohort-study
#9
Ammar Majeed, Anna Ågren, Margareta Holmström, Maria Bruzelius, Roza Chaireti, Jacob Odeberg, Eva-Lotta Hempel, Maria Magnusson, Tony Frisk, Sam Schulman
There is uncertainty regarding the effectiveness and occurrence of thromboembolic events in patients treated with prothrombin complex concentrates (PCCs) for the management of major bleeding events (MBEs) on rivaroxaban or apixaban. We investigated the effectiveness of PCCs given for the management of MBEs in patients on rivaroxaban or apixaban. Between 1 January 2014 and 1 October 2016, we prospectively included patients on rivaroxaban or apixaban treated with PCCs for the management of MBEs. The effectiveness of PCCs was assessed by using the International Society of Thrombosis and Hemostasis Scientific and Standardization Subcommittee criteria for the assessment of the effectiveness of major bleeding management...
October 12, 2017: Blood
https://www.readbyqxmd.com/read/28668628/effectiveness-and-safety-of-non-vitamin-k-antagonist-oral-anticoagulants-for-atrial-fibrillation-and-venous-thromboembolism-a-systematic-review-and-meta-analyses
#10
REVIEW
Abdulaali R Almutairi, Lili Zhou, Walid F Gellad, Jeannie K Lee, Marion K Slack, Jennifer R Martin, Wei-Hsuan Lo-Ciganic
PURPOSE: The findings from the observational studies comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) for atrial fibrillation (AF) and venous thromboembolism (VTE) are inconsistent. We conducted separate meta-analyses examining the efficacy/effectiveness and safety of NOACs versus VKAs by disease (AF vs VTE), study design (randomized controlled trials [RCTs] vs observational studies), and NOAC (dabigatran, rivaroxaban, apixaban, and edoxaban)...
July 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28655814/effectiveness-and-safety-of-apixaban-dabigatran-and-rivaroxaban-versus-warfarin-in-patients-with-nonvalvular-atrial-fibrillation-and-previous-stroke-or-transient-ischemic-attack
#11
COMPARATIVE STUDY
Craig I Coleman, W Frank Peacock, Thomas J Bunz, Mark J Alberts
BACKGROUND AND PURPOSE: Limited real-world data exist comparing each non-vitamin K antagonist oral anticoagulant (NOAC) to warfarin in patients with nonvalvular atrial fibrillation who have had a previous ischemic stroke or transient ischemic attack. METHODS: Using MarketScan claims from January 2012 to June 2015, we identified adults newly initiated on oral anticoagulation, with ≥2 diagnosis codes for nonvalvular atrial fibrillation, a history of previous ischemic stroke/transient ischemic attack, and ≥180 days of continuous medical and prescription benefits before anticoagulation initiation...
August 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28640322/effectiveness-and-safety-of-rivaroxaban-versus-warfarin-for-treatment-and-prevention-of-recurrence-of-venous-thromboembolism
#12
Craig I Coleman, Thomas J Bunz, Alexander G G Turpie
The efficacy and safety or rivaroxaban versus enoxaparin/vitamin K antagonist for treatment and prevention recurrence of venous thromboembolism (VTE) was demonstrated in the randomised EINSTEIN trials. We assessed the effectiveness and safety of rivaroxaban versus warfarin in VTE patients managed in routine practice. Using US MarketScan claims from 1/2012-6/2015, we included adults with a primary diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE) during a hospitalisation/emergency department visit, newly-initiated on rivaroxaban or warfarin within 30-days after the VTE and with ≥180-days of continuous medical/prescription benefits prior to the VTE (baseline)...
October 5, 2017: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/28431413/novel-oral-anticoagulants-and-trauma-the-results-of-a-prospective-american-association-for-the-surgery-of-trauma-multi-institutional-trial
#13
MULTICENTER STUDY
Leslie Kobayashi, Galinos Barmparas, Patrick Bosarge, Carlos V Brown, Marko Bukur, Matthew M Carrick, Richard D Catalano, Jan Holly-Nicolas, Kenji Inaba, Stephen Kaminski, Amanda L Klein, Tammy Kopelman, Eric J Ley, Ericca M Martinez, Forrest O Moore, Jason Murry, Raminder Nirula, Douglas Paul, Jacob Quick, Omar Rivera, Martin Schreiber, Raul Coimbra
BACKGROUND: The number of anticoagulated trauma patients is increasing. Trauma patients on warfarin have been found to have poor outcomes, particularly after intracranial hemorrhage (ICH). However, the effect of novel oral anticoagulants (NOAs) on trauma outcomes is unknown. We hypothesized that patients on NOAs would have higher rates of ICH, ICH progression, and death compared with patients on traditional anticoagulant and antiplatelet agents. METHODS: This was a prospective observational trial across 16 trauma centers...
May 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28035779/reduction-of-intracerebral-hemorrhage-by-rivaroxaban-after-tpa-thrombolysis-is-associated-with-downregulation-of-par-1-and-par-2
#14
Ryuta Morihara, Toru Yamashita, Syoichiro Kono, Jingwei Shang, Yumiko Nakano, Kota Sato, Nozomi Hishikawa, Yasuyuki Ohta, Stefan Heitmeier, Elisabeth Perzborn, Koji Abe
This study aimed to assess the risk of intracerebral hemorrhage (ICH) after tissue-type plasminogen activator (tPA) treatment in rivaroxaban compared with warfarin-pretreated male Wistar rat brain after ischemia in relation to activation profiles of protease-activated receptor-1, -2, -3, and -4 (PAR-1, -2, -3, and -4). After pretreatment with warfarin (0.2 mg/kg/day), low-dose rivaroxaban (60 mg/kg/day), high-dose rivaroxaban (120 mg/kg/day), or vehicle for 14 days, transient middle cerebral artery occlusion was induced for 90 min, followed by reperfusion with tPA (10 mg/kg/10 ml)...
September 2017: Journal of Neuroscience Research
https://www.readbyqxmd.com/read/28000559/in-models-of-intracerebral-hemorrhage-rivaroxaban-is-superior-to-warfarin-to-limit-blood-brain-barrier-disruption-and-hematoma-expansion
#15
Shigenobu Sawada, Yoko Ono, Yusuke Egashira, Toshinori Takagi, Kazuhiro Tsuruma, Masamitsu Shimazawa, Toru Iwama, Hideaki Hara
Intracerebral hemorrhage (ICH) during oral anticoagulation therapy with an oral vitamin K epoxidase reductase such as warfarin is a life-threatening complication. However, whether direct oral anticoagulants (DOACs) are associated with larger hematoma volume and higher mortality rates remains controversial. We evaluated the hematoma volume and pathophysiology of ICH during anticoagulation with warfarin or rivaroxaban, an orally active direct factor Xa inhibitor. Mice were orally pretreated with rivaroxaban (10 or 30 mg/kg), warfarin (4 mg/kg), or vehicle...
December 16, 2016: Current Neurovascular Research
https://www.readbyqxmd.com/read/27993122/in-models-of-intracerebral-hemorrhage-rivaroxaban-is-superior-to-warfarin-to-limit-blood-brain-barrier-disruption-and-hematoma-expansion
#16
Shigenobu Sawada, Yoko Ono, Yusuke Egashira, Toshinori Takagi, Kazuhiro Tsuruma, Masamitsu Shimazawa, Toru Iwama, Hideaki Hara
BACKGROUND: Intracerebral hemorrhage (ICH) during oral anticoagulation therapy with an oral vitamin K epoxidase reductase such as warfarin is a life-threatening complication. However, whether direct oral anticoagulants (DOACs) are associated with larger hematoma volume and higher mortality rates remains controversial. We evaluated the hematoma volume and pathophysiology of ICH during anticoagulation with warfarin or rivaroxaban, an orally active direct factor Xa inhibitor. METHOD: Mice were orally pretreated with rivaroxaban (10 or 30 mg/kg), warfarin (4 mg/kg), or vehicle...
2017: Current Neurovascular Research
https://www.readbyqxmd.com/read/27893153/efficacy-and-safety-of-dabigatran-rivaroxaban-and-warfarin-for-stroke-prevention-in-chinese-patients-with-atrial-fibrillation-the-hong-kong-atrial-fibrillation-project
#17
Wen-Hua Li, Duo Huang, Chern-En Chiang, Chu-Pak Lau, Hung-Fat Tse, Esther W Chan, Ian C K Wong, Gregory Y H Lip, Pak-Hei Chan, Chung-Wah Siu
BACKGROUND: Little is known about the comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOAC) compared to warfarin in Chinese atrial fibrillation (AF) patients. Our aim was to compare the ischemic stroke risk reduction and incidence of intracranial hemorrhage (ICH) of warfarin in relation to quality of anticoagulation control (as reflected by time in therapeutic range [TTR]), and to dabigatran and rivaroxaban in a real-world cohort of Chinese AF patients...
April 2017: Clinical Cardiology
https://www.readbyqxmd.com/read/27695821/stroke-bleeding-and-mortality-risks-in-elderly-medicare-beneficiaries-treated-with-dabigatran-or-rivaroxaban-for-nonvalvular-atrial-fibrillation
#18
COMPARATIVE STUDY
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...
November 1, 2016: JAMA Internal Medicine
https://www.readbyqxmd.com/read/27633045/real-world-evidence-of-stroke-prevention-in-patients-with-nonvalvular-atrial-fibrillation-in-the-united-states-the-revisit-us-study
#19
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...
December 2016: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/27296588/bleeding-in-patients-with-atrial-fibrillation-treated-with-dabigatran-rivaroxaban-or-warfarin-a-retrospective-population-based-cohort-study
#20
COMPARATIVE STUDY
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
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