Items filtered by date: December 2013

Antiplatelet and direct oral anticoagulation management after coronary artery bypass graft surgery: the Cinderella of current cardiovascular trials, please show me (some) evidence

European Heart Journal
This commentary discusses dual pathway inhibition therapy (DPI; aspirin + low dose direct oral anticoagulant) post coronary artery bypass graft surgery. The authors summarise available data, noting limited data in this specific patient cohort and call for further research.

 

Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy

Cochrane Database of Systematic Reviews
This review of 34 studies (n=1960) found the available evidence does not support the superiority of any anticoagulant to another. Further studies are needed to identify patient populations in which CRRT should commence with no pharmacological anticoagulation or with citrate.

 

Arterial and venous thromboembolism in COVID-19: a study-level meta-analysis

Thorax
This meta-analysis of 102 studies (n=64503) found patients admitted to the ICU for severe COVID-19 had a high risk of VTE. Further studies are needed to determine the specific effects of COVID-19 on the risk of thrombosis in less severe forms of the disease.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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Revised SPC: Plavix (clopidogrel) 300 mg film-coated tablets

electronic Medicines compendium
SPC have been updated with licence extension for use in combination with aspirin in adult patients with moderate to high-risk transient ischaemic attack (ABCD2-[1] score ≥4) or minor ischaemic stroke (NIHSS-[2] ≤3) within 24 hours of an event.

 

Comparative effectiveness of oral anticoagulants in everyday practice

Heart
Registry study (n=25,551) found DOACs were associated with a lower risk of all-cause mortality vs VKAs (3.6 vs 4.8 per 100 patient years, HR 0.79, 95%CI 0.70-0.89) and major bleeding (1.0 vs 1.4, 0.77, 0.61-0.98) with similar risk of non-haemorrhagic stroke or systemic embolism.

 

Comparison of the Efficacy and Safety Outcomes of Edoxaban in 8040 Women Versus 13 065 Men With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial

Circulation
Review of this study found that although pretreatment endogenous factor Xa activity was significantly higher in women than in men, treatment with edoxaban resulted in eventual similar endogenous factor Xa activity, and the efficacy profile was similar between sexes.

 

Prediction models for recurrence and bleeding in patients with venous thromboembolism: A systematic review and critical appraisal

Thombosis Research
Review (18 studies) findings do not support use of prediction models to weigh risks for recurrence and bleeding when deciding to anticoagulated patients after initial treatment of VTE. Important methodological limitations and insufficient predictive accuracy were found.

 

Direct oral anticoagulants in treatment of cerebral venous thrombosis: a systematic review

BMJ Open
Review of 33 studies (1 RCT, 5 observational cohorts and 27 case series, total n=594) concludes that the evidence for DOACs in cerebral venous thrombosis is limited, but suggests sufficient safety and efficacy vs standard therapy. Further rigorous trials are needed.

 

Prophylactic anticoagulation for patients in hospital with covid-19

British Medical Journal
This editorial discusses research to date on thromboprophylaxis in patients admitted to hospital with Covid-19 including the interim results from three separate RCTs (anticoagulation arm of REMAP-CAP, ATTACC, and ACTIV4a), widely available before peer-review.

 

Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy

Cochrane Database of Systematic Reviews
This updated review (32 RCTs [6 new]; n=15,678) found LMWH reduce, and direct factor Xa inhibitors may reduce, incidence of symptomatic VTE; both likely increase risk of major bleeding. Evidence for use of thromboprophylaxis with other anticoagulants is limited.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

 

 

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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.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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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

PharmaTimes
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.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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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

Heart
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.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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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

Circulation
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]).

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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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)

Heart
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.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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COVID-19, immunothrombosis and venous thromboembolism: biological mechanisms

Thorax
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.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

 

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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)

Portola
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.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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

Heart
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

Circulation
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.

 

 

The above records have been identified by UKMi and feature in the NICE Medicines Awareness Service. Further details on this service can be found at:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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