Association between prothrombin time and bleeding in hospitalized patients receiving rivaroxaban

Woodruff, Ashley E.; Wovkulich, Margaret; Mogle, Bryan T.; Hassan, Amany K.

doi:10.2146/ajhp180031

Cited by 11 publications

(14 citation statements)

References 15 publications

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“…Although based on small numbers, the work suggests that those at highest risk with low DOAC concentrations experience events. Woodruff et al (2018) investigated the association between prothrombin times and bleeding in hospitalised patients receiving rivaroxaban. In their single-centre retrospective cohort study, adult inpatients who had the prothrombin time (PT) measured within 24 h of rivaroxaban administration were identified and a multivariate logistic regression model was used to quantify the association between PT and bleeding events.…”

Section: What Can Be Learnt From the Clinical Trials Regarding Doac Cmentioning

confidence: 99%

“…In their single‐centre retrospective cohort study, adult inpatients who had the prothrombin time (PT) measured within 24 h of rivaroxaban administration were identified and a multivariate logistic regression model was used to quantify the association between PT and bleeding events. In total, 199 patients were identified, of which 41 experienced a bleeding event; patients with a PT ≥ 30 s were more likely to have experienced a bleeding event, than those with a PT < 30 s (Woodruff et al , ). This study however does not report the exact time after dose that the PTs were measured, so it is difficult to know if like is being compared to like (in terms of time after dose) and therefore, it is again difficult to draw any firm conclusions from this.…”

Section: What Evidence Has Been Reported From the Real‐world?mentioning

confidence: 99%

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Progress in the monitoring of direct oral anticoagulant therapy

et al. 2019

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Summary The availability of direct oral anticoagulants (DOACs) has led to a paradigm shift in the field of anticoagulation, with DOACs increasingly being prescribed for patients in preference to vitamin K antagonists and low molecular weight heparin. Despite good experience with the use of these agents at fixed doses, there are clinical scenarios where monitoring is recommended. Data from phase III studies of the DOACs and small real‐world studies suggest a relationship between DOAC concentration and clinical events. The DOACs have differing impacts on the common tests of haemostasis and it is important that clinicians are familiar with the sensitivity of the reagents used in their laboratory to individual DOACs. The specific DOAC drug concentrations can be assayed in the laboratory, when required, to guide appropriate clinical decision‐making. Studies from the real world with sufficient numbers evaluating the association of DOAC concentrations with outcomes should be a research priority in order to understand if we could do better through dose individualisation.

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Section: What Can Be Learnt From the Clinical Trials Regarding Doac Cmentioning

confidence: 99%

Section: What Evidence Has Been Reported From the Real‐world?mentioning

confidence: 99%

Progress in the monitoring of direct oral anticoagulant therapy

et al. 2019

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“…28 Woodruff et al compared PT levels measured within 24 hours of taking rivaroxaban in a retrospective study (n ¼ 199) and were able to conclude that patients with PT >30 seconds (twice the upper limit of the normal PT of the assay used in the study) had a threefold higher bleeding risk compared with those with PT <30 seconds (p ¼ 0.006). 29 In a recent study involving 94 patients, Sakaguchi et al showed that the rivaroxaban peak concentration was an independent predictive bleeding risk factor (p ¼ 0.012). Trough levels were not associated with bleeding in this study.…”

Section: Rivaroxabanmentioning

confidence: 98%

“…76 Finally, hypoalbuminemia, a frequent condition in the elderly, has also been associated with higher rates of bleeding in rivaroxaban-taking patients. 29 Elderly patients are a fragile population in which bleeding events could be more frequent for those taking DOACs. Severity and consequences of bleeding events are likely to be worse in older patients due to frailty and comorbidities.…”

Section: Elderly Patientsmentioning

confidence: 99%

“…88 In addition to DOAC accumulation due to liver failure, hypoalbuminemia, a common factor in cirrhosis, is associated with higher bleeding rates in rivaroxaban. 29 Therefore, specific care should be taken in cirrhotic patients receiving DOACs, especially since hepatic vein thrombosis is starting to be treated with DOACs off label. 89 Monitoring DOAC concentrations in this patient population could lead to better safety and efficacy but studies are needed to confirm the usefulness of it.…”

Section: Liver Insufficiencymentioning

confidence: 99%

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Does One Dose Really Fit All? On the Monitoring of Direct Oral Anticoagulants: A Review of the Literature

2020

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Background There is an increasing amount of literature on direct oral anticoagulant (DOAC) laboratory monitoring. The aims of the present review were to evaluate published data on monitoring DOACs, to provide clinical guidance on how to interpret results, and to summarize why, when, and how to monitor DOACs. Methods The publications screened for this review were obtained through a PubMed search for articles published in English or French before April 2019 that had the following as their main themes: DOAC monitoring, DOAC exposure–effect relationship, DOAC drug interactions, and pharmacokinetics and pharmacodynamics of DOACs. Results DOACs show important inter- and intrapersonal concentration variability and a significant exposure–effect relationship. Concentrations out of the expected range have been shown to lead to an increased adverse event rate and a lower efficacy. No definitive therapeutic range exists for DOACs except for dabigatran for which trough levels of 40 to 200 ng/mL seem to be the consensus. Indications to monitor include suspected drug accumulation in special patient populations, suspected drug failure, and acute situations such as hemorrhagic or thrombotic events. Conclusion There is a likely benefit to monitor DOACs in order to improve their safety and efficacy but randomized controlled trials are required to determine the therapeutic range of these drugs and evaluate whether DOAC monitoring can improve outcomes in a clinical setting.

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Nomogram for predicting bleeding events in nonvalvular atrial fibrillation patients receiving rivaroxaban: A retrospective study

Cao,

Xu,

Jiang

et al. 2024

Health Science Reports

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Background and AimsTo construct a bleeding events prediction model of nonvalvular atrial fibrillation (NVAF) patients receiving rivaroxaban.MethodsWe conducted a retrospective cohort study in patients with NVAF who received rivaroxaban from June 2017 to March 2019. Demographic information and clinical characteristics were obtained from the electronic medical system. Univariate analysis was used to find the primary predictive factors of bleeding events in patients receiving rivaroxaban. Multiple analysis was conducted to screen the primary independent predictive factors selected from the univariate analysis. Finally, the independent influencing factors were applied to build a prediction model by using R software; then, a nomogram was established according to the selected variables visually, and the sensitivity and specificity of the model was evaluated.ResultsTwelve primary predictive factors were selected by univariate analysis from 46 variables, and multivariate analysis showed that older age, higher prothrombin time (PT) values, history of heart failure and stroke were independent risk factors of bleeding events. The area under curve (AUC) for this novel nomogram model was 0.828 (95% CI: 0.763–0.894). The mean AUC over 10‐fold stratified cross‐validation was 0.787, and subgroup analysis validation also showed a satisfied AUC. In addition, the decision curve analysis showed that the PT in combination with CHA2DS2‐VASc and HASBLED was more practical and accurate for predicting bleeding events than using CHA2DS2‐VASc and HASBLED alone.ConclusionsPT in combination with CHA2DS2‐VASc and HASBLED could be considered as a more practical and accurate method for predicting bleeding events in patients taking rivaroxaban.

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Association between prothrombin time and bleeding in hospitalized patients receiving rivaroxaban

Abstract: In hospitalized patients receiving rivaroxaban who had coagulation tests performed, a PT of ≥30 seconds was associated with a higher risk of bleeding. Hypoalbuminemia was also associated with bleeding in this population.

Cited by 11 publications

References 15 publications

Progress in the monitoring of direct oral anticoagulant therapy

Progress in the monitoring of direct oral anticoagulant therapy

Does One Dose Really Fit All? On the Monitoring of Direct Oral Anticoagulants: A Review of the Literature

Nomogram for predicting bleeding events in nonvalvular atrial fibrillation patients receiving rivaroxaban: A retrospective study

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