Observational studyClinical cardiology2015
Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27 467 patients taking rivaroxaban.
Observational study in Clinical cardiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04315974 (Italian Registry In the Setting of AF Ablation With Rivaroxaban), which is not on this map. Cited by 47 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Italian Registry In the Setting of AF Ablation With Rivaroxaban
Who cites it
47 citing papers in PubMed.
- Impact of Switching From a Vitamin K Antagonist to Rivaroxaban on Satisfaction With Anticoagulation Therapy: The XANTUS-ACTS Substudy.Clinical cardiology · 2016Trial
- Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban.Heart (British Cardiac Society) · 2016Trial
- Engineering and evaluation of FXa bypassing agents that restore hemostasis following Apixaban associated bleeding.Nature communications · 2024Article
- Nomogram for predicting bleeding events in nonvalvular atrial fibrillation patients receiving rivaroxaban: A retrospective study.Health science reports · 2024Article
- Lower mortality with andexanet alfa vs 4-factor prothrombin complex concentrate for factor Xa inhibitor-related major bleeding in a U.S. hospital-based observational study.Research and practice in thrombosis and haemostasis · 2023Article
- Identification of International Society on Thrombosis and Haemostasis major and clinically relevant non-major bleed events from electronic health records: a novel algorithm to enhance data utilisation from real-world sources.International journal of population data science · 2023Article
- Five Years of Direct Oral Anticoagulants Use in Italy: Adverse Drug Reactions from the Italian National Pharmacovigilance Network.Journal of clinical medicine · 2022Article
- Elderly people are inherently sensitive to the pharmacological activity of rivaroxaban: implications for DOAC prescribing.Journal of thrombosis and thrombolysis · 2021Article
- Impact of Modifiable Bleeding Risk Factors on Major Bleeding in Patients With Atrial Fibrillation Anticoagulated With Rivaroxaban.Journal of the American Heart Association · 2020Observational
- Effectiveness and safety of direct oral anticoagulants compared to warfarin in treatment naïve non-valvular atrial fibrillation patients in the US Department of defense population.BMC cardiovascular disorders · 2019Observational
- Hospital admissions for bleeding events associated with treatment with apixaban, dabigatran and rivaroxaban.European journal of hospital pharmacy : science and practice · 2019Article
- Real-World Comparative Effectiveness, Safety, and Health Care Costs of Oral Anticoagulants in Nonvalvular Atrial Fibrillation Patients in the U.S. Department of Defense Population.Journal of managed care & specialty pharmacy · 2018Article
- Pharmacogenetic studies with oral anticoagulants. Genome-wide association studies in vitamin K antagonist and direct oral anticoagulants.Oncotarget · 2018Review
- Characteristics, Management, and Outcomes of Patients with Atrial Fibrillation Experiencing a Major Bleeding Event While on Rivaroxaban.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2018Article
- Incidence and characteristics of major bleeding among rivaroxaban users with renal disease and nonvalvular atrial fibrillation.Clinical and experimental emergency medicine · 2018Article
- Agreement between coding schemas used to identify bleeding-related hospitalizations in claims analyses of nonvalvular atrial fibrillation patients.Clinical cardiology · 2018Article
- Reversal Strategies for Intracranial Hemorrhage Related to Direct Oral Anticoagulant Medications.Critical care research and practice · 2018Review
- A Cross-Study Analysis Evaluating the Effects of Food on the Pharmacokinetics of Rivaroxaban in Clinical Studies.Journal of clinical pharmacology · 2017Article
- Management and outcome of gastrointestinal bleeding in patients taking oral anticoagulants or antiplatelet drugs.Journal of gastroenterology · 2017Article
- Comparative effectiveness of rivaroxaban in the treatment of nonvalvular atrial fibrillation.Journal of comparative effectiveness research · 2017Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn nonvalvular atrial fibrillation (NVAF), rivaroxaban is used to prevent stroke and systemic embolism.
objectiveTo evaluate major bleeding (MB) in NVAF patients treated with rivaroxaban in a real-world clinical setting.
methodsFrom January 1, 2013, to March 31, 2014, US Department of Defense electronic health care records were queried to describe MB rates and demographics. Major bleeding was identified using a validated algorithm.
resultsOf 27 467 patients receiving rivaroxaban, 496 MB events occurred in 478 patients, an incidence of 2.86 per 100 person-years (95% confidence interval: 2.61-3.13). The MB patients were older, mean (SD) age of 78.4 (7.7) vs 75.7 (9.7) years, compared with non-MB patients. Patients with MB had higher rates of hypertension (95.6% vs 75.8%), coronary artery disease (64.2% vs 36.7%), heart failure (48.5% vs 23.7%), and renal disease (38.7% vs 16.7%). Of MB patients, 63.2% were taking 20 mg, 32.2% 15 mg, and 4.6% 10 mg of rivaroxaban. Four percent of MB patients took warfarin within the prior 30 days. Major bleeding was most commonly gastrointestinal (88.5%) or intracranial (7.5%). Although 46.7% of MB patients received a transfusion, none had sufficient evidence of receiving any type of clotting factor. Fourteen died during their MB hospitalization, yielding a fatal bleeding incidence rate of 0.08 per 100 person-years (95% confidence interval: 0.05-0.14). Mean age at death was 82.4 years.
conclusionsIn this large observational study, the MB rate was generally consistent with the registration trial results, and fatal bleeds were rare.
Indexed as
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.