Risk Factors for Major Bleeding in Rivaroxaban Users With Atrial Fibrillation

Tamayo, Sally; Simeone, Jason C; Nordstrom, Beth L.; Patel, Manesh R.; Yuan, Zuyi; Sicignano, Nicholas; Peacock, W. Frank

doi:10.1016/j.jacc.2016.06.028

Cited by 6 publications

(7 citation statements)

References 5 publications

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“…The higher proportion of patients with falling tendency, ischemic heart disease or with a history of a recent fracture or brain injury in the group of patients with Hb-relevant bleeding may put this population at increased risk of complications following TDA. Although it was suggested that anemia might contribute to the major bleeding under rivaroxaban therapy [18], our study showed a lower proportion of anemia in patients with Hb-relevant bleeding. However, the risk of bleeding may also be affected by other contributing factors.…”

Section: Has-bled Score Of the Patient Populationcontrasting

confidence: 75%

“…In addition to the components of the HAS-BLED score, other clinical parameters predisposing the AK-receiving patients to bleed such as the history of congestive heart failure, cerebrovascular disease, and anemia have also been taken into account. Tamaya et al in a case-control study of 3252 patients with atrial fibrillation under rivaroxaban-therapy showed that the mentioned parameters, which have been ignored by HAS-BLED score, are the strongest predictive factors for bleeding complications [18]. Consistently, more than 20% of patients with TDA had a positive history of stroke or TIA.…”

Section: Discussionmentioning

confidence: 97%

“…Despite having a similar accuracy, the HAS-BLED score has the best predictive performance [35,36]. These scores have been mainly validated for VKA therapy in patients with atrial fibrillation and, therefore, modified HAS-BLED scores have been proposed to assess the risk of bleeding in other circumstances such as anticoagulation with DOACs [18,37]. Except for one patient who has been found to concomitantly receive VKA, LMWH, and heparin and one other who received the combination of LMWH and heparin, all other TDA patients have been anticoagulated by DOACs.…”

Section: Discussionmentioning

confidence: 99%

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Therapeutic duplication of anticoagulants: a retrospective study of frequency and consequences in a tertiary referral hospital

et al. 2020

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Background: Anticoagulants are commonly prescribed in medical practices and could be of significant harm in the case of medication errors. We conducted a retrospective observational study to determine the frequency and consequences of the therapeutic duplication of anticoagulants (TDA). As a secondary objective, we aimed to determine the characteristics of the population in which TDA occurs. Methods: We conducted a retrospective observational study among admitted patients who concomitantly received at least two anticoagulants from August 2017 to August 2018. Results: A total of 107 patients with TDA are included in the research. The patients with TDA have a mean age of 73. The TDA population has a high rate of associated comorbidities with 69% of patients having arterial hypertonia, 40% with chronic kidney disease, 26% with a history of malignancy, and 20.5% with a history of stroke. More than 65% of patients were under anticoagulation before admission, mostly due to atrial fibrillation. The TDA occurred in more than 95% of cases in the first week or the last week of hospitalization. Patients had a high risk of bleeding prior to the TDA-event with about 62.5% of TDA patients having a HAS-BLED score at least 3. A total of 8 patients showed a significant Hemoglobin (Hb)-drop of at least 10 g/L within 24 h after TDA-event. Two patients had a new or worsened hematuria following TDA-event. Conclusion: TDA occurred in 0.8% of patients who were under anticoagulation and in 6.7% of patients who received direct oral anticoagulants (DOACs). TDA led in about 7.4% of cases to hemoglobin-relevant bleeding. The old patients with significant comorbidities and a high HAS-BLED score were mainly affected. The female gender and presence of anemia independently predicted the occurrence of bleeding following TDA.

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Section: Has-bled Score Of the Patient Populationcontrasting

confidence: 75%

Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

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Therapeutic duplication of anticoagulants: a retrospective study of frequency and consequences in a tertiary referral hospital

et al. 2020

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“…Continuing investigations from PMSS will focus on the more detailed characterisations of real-world bleeding rates with rivaroxaban and associated risk factors. The strongest risk factors identified to date include increased age, anaemia, prior GI bleeding, heart failure, and vascular disease (nested case-control study; p<0.0001 for all) (54).…”

Section: Pmss: Safety Profile Of Rivaroxaban In Patients With Non-valmentioning

confidence: 99%

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice

Beyer‐Westendorf¹,

Camm²,

Coleman³

et al. 2016

Thromb Haemost

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Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

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“… 11 29 34 Because of these limitations, the results of case–control studies are most appropriately used for hypothesis generation, 11 34 35 and have primarily been used to assess whether NOAC treatment is a risk factor for rare outcomes or safety outcomes in specific patient populations. 34–36 …”

Section: Non-interventional Studiesmentioning

confidence: 99%

Strengths and weaknesses of ‘real-world’ studies involving non-vitamin K antagonist oral anticoagulants

2018

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Randomised controlled trials (RCTs) provide the reference standard for comparing the efficacy of one therapy or intervention with another. However, RCTs have restrictive inclusion and exclusion criteria; thus, they are not fully representative of an unselected real-world population. Real-world evidence (RWE) studies encompass a wide range of research methodologies and data sources and can be broadly categorised as non-interventional studies, patient registries, claims database studies, patient surveys and electronic health record studies. If appropriately designed, RWE studies include a patient population that is far more representative of unselected patient populations than those of RCTs, but they do not provide a robust basis for comparing treatment strategies. RWE studies can have very large sample sizes, can provide information on treatments in patient groups that are usually excluded from RCTs, are generally less expensive and quicker than RCTs, and can assess a broad range of outcomes. Limitations of RWE studies can include low internal validity, lack of quality control surrounding data collection and susceptibility to multiple sources of bias for comparing outcomes. RWE studies can complement the findings from RCTs by providing valuable information on treatment practices and patient characteristics among unselected patients. This information is necessary to guide treatment decisions and for reimbursement and payment decisions. RWE studies have been extensively applied in the postmarketing approval assessment of non-vitamin K antagonist oral anticoagulants since 2010. However, the benefits, costs, limitations and methodological challenges associated with the different types of RWE must be considered carefully when interpreting the findings.

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Risk Factors for Major Bleeding in Rivaroxaban Users With Atrial Fibrillation

Cited by 6 publications

References 5 publications

Therapeutic duplication of anticoagulants: a retrospective study of frequency and consequences in a tertiary referral hospital

Therapeutic duplication of anticoagulants: a retrospective study of frequency and consequences in a tertiary referral hospital

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice

Strengths and weaknesses of ‘real-world’ studies involving non-vitamin K antagonist oral anticoagulants

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