Revised SPC: Xarelto (rivaroxaban) film-coated tablets – all strengths

electronic Medicines compendium
SPC updated with license extension for the treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.


Early initiation of prophylactic anticoagulation for prevention of coronavirus disease 2019 mortality in patients admitted to hospital in the United States: cohort study

British Medical Journal
Study of patients admitted to hospital with Covid-19 (n=4297) found receipt of thromboprophylaxis within 24 hours of admission was associated with lower 30-day mortality (14.3% v 18.7% no anticoagulation; HR 0.73, 95% CI 0.66 to 0.81) with no increased risk of severe bleeding.



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DOAC Dipstick for detecting direct oral anticoagulants - Medtech innovation briefing [MIB248]

National Institute for Health and Care Excellence
This briefing describes the DOASENSE DOAC Dipstick, which is used for detecting direct oral anticoagulants (DOACs) in urine. A summary of the main relevant evidence is presented along with uncertainties in the evidence, the technology's potential place in therapy and its cost.


Rivaroxaban approved for use in EU (and UK) for treatment, and prevention of recurrence of venous thromboembolism

It will be licensed for treatment and prevention of venous thromboembolism recurrence in children from birth to below 18 years old, at least five days after initial parenteral anticoagulation treatment.


Management of Antithrombotic Therapy after Acute Coronary Syndromes

New England Journal of Medicine
This review article notes antithrombotic therapy is a central component of treatment after acute coronary syndromes; however, balancing the benefit with the bleeding risk is still controversial. Clinical research and recommended approaches to management are reviewed.



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Nebulised heparin for patients with or at risk of acute respiratory distress syndrome: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial

The Lancet Respiratory Medicine
Australian RCT (n=252) found no difference in Short Form 36 Health Survey Physical Function Score at day 60 in patients treated with nebulised heparin or placebo (mean 53.6 vs 48.7; difference 4.9; 95% CI −4.8 to 14.5]; p=0.32).


Thrombosis, Bleeding, and the Observational Effect of Early Therapeutic Anticoagulation on Survival in Critically Ill Patients With COVID-19

Annals of Internal Medicine
Study (n=3,239) found during median follow-up of 27 days, patients who received early therapeutic anticoagulation had similar risk for death as those who did not (hazard ratio, 1.12 [95% CI, 0.92 to 1.35]) and reports early therapeutic anticoagulation did not affect survival.


National Institute for Health Research Alert: Aspirin could reduce the risk of heart attack or stroke in people with pneumonia, research suggests

National Institute for Health Research
Expert commentary is provided for a cohort study which found the risk of cardiovascular events six months after pneumonia diagnosis was one-third lower among aspirin users. Although this is a promising finding, use of aspirin for pneumonia cannot be recommended at present.


Valvular atrial fibrillation and a CHA2DS2-VASc score of 1—a statement of the ESC working group on cardiovascular pharmacotherapy and ESC council on stroke

European Heart Journal
Consensus statement provides factors to consider when reviewing the risk/benefit decision for anticoagulation in patients with CHA2DS2-VASc score of 1. A decision tree is provided to support clinicians.


Antiplatelet therapy in patients with myocardial infarction without obstructive coronary artery disease

Patients with MI with non-obstructive coronary arteries, when compared to those with obstructive CAD, had lower overall and CV mortality, repeat MI and major bleeding; intensified clopidogrel offered no additional benefit (2.1% v 0.6% standard dose experienced primary outcome).


Atrial fibrillation

New England Journal of Medicine
This article on atrial fibrillation begins with a case vignette, then goes on to discuss diagnosis and evaluation, treatment (rate control; stroke prevention; maintenance of sinus rhythm), and guidelines, and concludes with the authors clinical recommendations.



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Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients with Atrial Fibrillation After Acute Coronary Syndrome or PCI: Insights from The AUGUSTUS Trial

Review of the AUGUSTUS trial (n=4,456, reporting apixaban caused less bleeding and fewer hospitalisations than vitamin K antagonists in AF after ACS or PCI) found the safety and efficacy of apixaban was consistent irrespective of kidney function, as compared with warfarin.


Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial

Journal of the American Medical Association
RCT in 234 patients with acute ischaemic stroke found endovascular treatment (EVT) alone was noninferior to i/v alteplase plus EVT (functional independence at 90 days was achieved in 54.3% vs 46.6% respectively, a difference that met the prespecified noninferiority margin of 10%).


Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke: The SKIP Randomized Clinical Trial

Journal of the American Medical Association
Trial in patients (n=204) with acute large vessel occlusion stroke failed to demonstrate non-inferiority (NI) of mechanical thrombectomy (MT) alone vs. combined i/v thrombolysis plus MT for favourable functional outcome (OR 1.09 [95% confidence limit below the NI margin of 0.74]).



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Residual risks of ischaemic stroke and systemic embolism among atrial fibrillation patients with anticoagulation: large-scale real-world data (F-CREATE project)

In this Japanese retrospective cohort study (n=11,848), there were 0.57 cases of ischaemic stroke and systemic embolism per 100 person-years during mean of 3 yrs; 30% (95% CI 16.1-41.6%) of risk was attributable to modifiable risk factors (hypertension, diabetes, dyslipidaemia).


Positive Phase III results for valoctocogene roxaparvovec in the treatment of severe haemophilia A

Biospace Inc.
In the GENEr8-1 study (n=134), a single dose of valoctocogene roxaparvovec reduced annualised bleeding rate from a mean of 4.8 episodes per year at baseline to 0.8 per year, after a mean follow-up of 71.6 weeks (p<0.0001).


Revised SPC: Lixiana (edoxaban) Film-Coated Tablets – all strengths

electronic Medicines compendium
SPC advises that for patients unable to swallow, tablets may be crushed and mixed with water/apple puree and immediately administered. Alternatively, tablets may be crushed and suspended in water and immediately delivered through a gastric tube followed by flushing with water.



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COVID-19, immunothrombosis and venous thromboembolism: biological mechanisms

Review explores the pathobiological mechanisms of immunothrombosis and VTE in COVID-19 focusing on COVID-19-associated coagulopathy, pathology, endothelial dysfunction and haemostasis, the immune system and thrombosis, genetic associations and additional thrombotic mechanisms.


SSRI/SNRI antidepressant medicines: small increased risk of postpartum haemorrhage when used in the month before delivery

Medicines and Healthcare products Regulatory Agency
Data from observational studies suggest use of SSRI/SNRI antidepressants during month before delivery may result in small increased risk of postpartum haemorrhage. Prescribers should consider this risk vs. benefits of antidepressants for patient's mental health during this time.


Compression stockings in addition to low-molecular-weight heparin to prevent venous thromboembolism in surgical inpatients requiring pharmacoprophylaxis: the GAPS non-inferiority RCT

National Institute for Health Research
RCT (n=1,858) found pharmaco-thromboprophylaxis alone was non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings in terms of venous thromboembolism up to 90 days after surgery (1.7% vs 1.4%, p<0.001 for non-inferiority).


Evolution of antithrombotic therapy in patients undergoing percutaneous coronary intervention: a 40-year journey

European Heart Journal
Article aims to provide an overview of the important milestones in antithrombotic pharmacology that have shaped clinical practice of today while also providing insights into knowledge gaps and future directions.



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Therapeutic Anticoagulation (Heparin) in the Management of Severe COVID-19 (SARS-CoV-2 Positive) Patients

Chief Medical Officer
Alert advises not to use therapeutic dose UFH or LMWH for patients with COVID-19, unless there is a standard indication (e.g. acute VTE), as the REMAP-CAP study has reported therapeutic dose of heparin does not improve clinical outcome in the critical care setting.


Pfizer-BioNTech COVID-19 Vaccine use in anticoagulation and bleeding disorders

Specialist Pharmacy Service
This page summarises and signposts Information on use of the vaccine in patients who are receiving anticoagulants or have a bleeding disorder.


Letter sent to Healthcare Professionals: Ondexxya (andexanet alfa)

Letter advises to avoid use of andexanet alfa before heparinisation (e.g. during surgery) because it causes unresponsiveness to anticoagulant effects of heparin and results of coagulation tests might be misleading when both given within a short time of one another.



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Discontinuation of oral anticoagulation in atrial fibrillation and risk of ischaemic stroke

Population-based cohort study with nested case–control analysis (76 882 UK;41526 Denmark) found pts who discontinued oral anticoagulation therapy had a two to threefold higher risk of ischaemic stroke vs current users (UK OR 2.99; 95% CI 2.31 to 3.86: Denmark 2.30; 1.79 to 2.95).


Bleeding with Apixaban and Dalteparin in Patients with Cancer-Associated Venous Thromboembolism: Results from the Caravaggio Study

Thrombosis and Haemostasis
Study reports no excess in GI bleeding in patients who received apixaban, including those with GI cancer; major bleeding occurred in 22 of 576 on apixaban (3.8%) and in 23 of 579 patients on dalteparin (4.0%). The sites of major bleeding were similar between the two groups.


Stroke Prevention in Atrial Fibrillation: Looking Forward

Review summarises the major advances in stroke prevention for patients with atrial fibrillation during the past 30 years and focuses on novel diagnostic and treatment approaches currently under investigation in ongoing clinical trials.


Erythromycin: caution required due to cardiac risks (QT interval prolongation); drug interaction with rivaroxaban

Medicines and Healthcare products Regulatory Agency
Erythromycin should not be given to patients with a history of QT interval prolongation or ventricular cardiac arrhythmia. A potential drug interaction between rivaroxaban and erythromycin resulting in increased risk of bleeding has also been identified.



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Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial

The Lancet Haematology
RCT (n=328) found age/weight adjusted dabigatran non-inferior to standard of care (LMWH/unfractionated heparin/vit K antagonists/fondaparinux) for the composite efficacy endpoint of thrombus resolution, & no recurrent VTE or VTE-death: 42%vs 46%; p<0.0001).


Short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy vs. prolonged dual antiplatelet therapy after percutaneous coronary intervention with second-generation drug-eluting stents: a systematic review and meta-analysis of randomized clinical trials

European Heart Journal
Review (5 RCTs, n=32,145) reports 1–3 months of dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor single antiplatelet therapy is associated with lower major bleeding and similar stent thrombosis, all-cause death, myocardial infarction & stroke vs. prolonged DAPT.


Association Between Prehospital Tranexamic Acid Administration and Outcomes of Severe Traumatic Brain Injury

JAMA Neurology
Prospective study (n=1,827) found prehospital tranexamic acid increased mortality in patients with isolated severe traumatic brain injury (OR 4.49; 95% CI, 1.57-12.87; p=0.005), highlighting need for judicious use of the drug when there is no evidence for extracranial haemorrhage.


Meta-Analysis of Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin According to Time in Therapeutic Range in Atrial Fibrillation

American Journal of Cardiology
Review of RCTs investigating time in therapeutic range (TTR) found, across all TTR levels, DOACs had lower risk of stroke or systemic embolism vs warfarin (HR 0.73, 95%CI 0.61-0.88). There was a lower risk of major bleeding for DOACs vs warfarin in medium or low TTR only.


Risk factors for emergency department revisit in elderly patients with gastrointestinal bleeding secondary to anticoagulant therapy

European Journal of Hospital Pharmacy
Study in 80 patients on oral anticoagulants who visited the emergency department (ED) for gastrointestinal bleeding found 13.7% revisited the ED for bleeding episodes 30 days after hospital discharge, with no particular differences between the types of anticoagulant prescribed.


Retinal vascular occlusions

The Lancet
This review article looks at management of retinal vascular occlusions, which are common causes of visual impairment. Acute management of retinal artery occlusions involves a multidisciplinary approach, whereas treatment of retinal vein occlusions is provided by ophthalmologists.


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Implementing point-of-care D-dimer tests for deep vein thrombosis (DVT)

City Health Care Partnership CIC

NG158 recommends considering the use of POC D-dimer tests as an alternative to laboratory D-dimer tests. Since implementing the tests, the main advantage has been the reduction in time from the person presenting, to diagnosis and receiving treatment.

Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation

Prospective cohort study (n=1,903) found major bleeding was significantly lower with rivaroxaban as compared to use of vitamin K antagonists (7.4 vs 14.6 per 100 patient years, HR 0.66, 95% CI 0.43-0.99). This was largely driven by lower risk of intracerebral bleeding.


Inappropriate Prescriptions of Direct Oral Anticoagulants among Patients with Atrial Fibrillation in General Practice: a Cross-sectional Analysis of the French CACAO Cohort Study

British Journal of General Practice
In this analysis (n=438), 39.4% received at least one inappropriate DOAC prescription – mainly under-dosing (31.3%). Factors independently associated with under-dosing were older age, those with kidney failure, a higher risk for ischemic stroke and/or a higher risk for bleeding.


Differences in risk factors for anticoagulant‐related nephropathy between warfarin and direct oral anticoagulants: analysis of the Japanese Adverse Drug Event Report database

British Journal of Clinical Pharmacology
This short report describes research suggesting the risk factors for kidney injury in people using warfarin (male sex and age ≥80 years) were different to those in people using DOACs (weight ≥80 kg and use of dabigatran); these factors may be associated with bleeding risk.



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