Items filtered by date: December 2015

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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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.

 

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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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

Heart
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.

 

 

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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The Use of Therapeutic-Dose Anticoagulation and Its Effect on Mortality in Patients With COVID-19: A Systematic Review

Clinical and Applied Thrombosis/Hemostasis
Of 8 studies in review, 3 retrospective cohort studies reported reduction in mortality rate, while 5 other studies showed no mortality benefits in this population. There was slight tendency toward reduction in mortality rate among mechanically-ventilated patients with COVID-19.

 

Safety of direct oral anticoagulant exposure during pregnancy: a retrospective cohort study

The Lancet Haematology
Study (n=1,193 reports of exposure, mean duration 5.3 weeks) finds that although reports are missing important details & predominantly describe rivaroxaban exposures, available data do not suggest direct oral anticoagulant exposure in pregnancy carries a high risk of embryopathy.

 

Diagnosis, Management, and Pathophysiology of Arterial and Venous Thrombosis in COVID-19

Journal of the American Medical Association
Review summarises pathophysiology underlying thrombotic diathesis characteristic of acute covid-19 infection and recommendations for prevention, diagnosis & management of complications e.g. acute myocardial infarction, ischaemic stroke, and venous thromboembolism.

 

Pharmacist-led atrial fibrillation case finding programme prevents an estimated 90 strokes

Pharmaceutical Journal
Following the pharmacist-led programme, Quality Outcomes Framework results for 2019–2020 across 23 CCGs showed an encouraging increase in the rate of anticoagulation of 3.45% in those with a record of a CHA2DS2-VASc score of ≥ 2 vs. 1.38% for all other CCGs across England.

 

Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3‐year period population‐based prospective cohort study

British Journal of Clinical Pharmacology
Study (n=47,469) found high and low‐dose DOACs linked to reduced risk of intracranial haemorrhage (aHR 0.55, 95% CI 0.37–0.82 & 0.54, 0.26–1.12 respectively), and reduced risk of other major bleeding events, irrespective of duration and indication, vs. vitamin K antagonists.

 

Direct oral anticoagulants: evidence and unresolved issues

The Lancet
In this Therapeutics paper, the authors review pharmacology, the evidence that led to approval and incorporation into treatment guidelines, key unresolved issues, and future perspectives for the development of oral anticoagulants.

 

 

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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European CHMP recommends paediatric license extension and new strength of rivaroxaban (Xarelto)

European Medicines Agency
The license extension, treatment of VTE and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged < 18 years after at least 5 days of initial parenteral anticoagulation treatment, is supported by a new 1 mg/ml oral suspension.

 

European CHMP recommends paediatric license extension and paediatric formulations of dabigatran etexilate (Pradaxa)

European Medicines Agency
Paediatric license extension, treatment of VTE and prevention of recurrent VTE from birth to <18 years of age, is supported by a new pharmaceutical form and strength – coated granules (20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg) and oral solution (6.25 mg/ml).

 

Beyond the clot: perfusion imaging of the pulmonary vasculature after COVID-19

The Lancet Respiratory Medicine
In this Personal View, a proactive follow-up strategy to evaluate residual clot burden, small vessel injury, and potential haemodynamic sequelae is proposed, as well as a nuanced approach looking beyond the clot, and at the state of perfusion of lung tissue.

 

Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve

New England Journal of Medicine
RCT (n=1,005) reports rivaroxaban was non-inferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months; 347.5 vs 340.1 days, respectively (difference 7.4 days; 95% CI −1.4 to 16.3; P<0.001).

 

COVID-19 rapid guideline: reducing the risk of venous thromboembolism in over 16s with COVID-19 – guidance (NG186)

National Institute for Health and Care Excellence
This guideline covers pharmacological VTE prophylaxis for patients being treated for COVID-19 pneumonia. It includes patients receiving treatment in hospital or in a community setting such as a 'hospital at home' service or COVID-19 'virtual ward'.

 

Draft updated venous thromboembolic diseases quality standard out for consultation

National Institute for Health and Care Excellence
This DRAFT quality standard update covers reducing the risk of VTE in people aged ≥16 who are in hospital, and diagnosing and treating VTE in all people aged ≥18. It describes high-quality care in priority areas for improvement.

 

 

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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Antiplatelet and anticoagulant agents for secondary prevention of stroke and other thromboembolic events in people with antiphospholipid syndrome

Cochrane Database of Systematic Reviews
Review (8 RCTs; n=811; moderate‐certainty evidence) concludes that DOACs probably increase risk of stroke but may not alter risk of any thromboembolic events, major bleeding, mortality or clinically‐relevant non‐major bleeding vs standard‐dose warfarin.

 

Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data

The Lancet
Review (4 RCTs; n=843) found intravenous alteplase resulted in better functional outcome (score of 0–1 on modified Rankin Scale) at 90 days vs placebo/standard care (47% vs 39%; adjusted OR 1.49; 95% CI 1.10–2.03) but with higher risk of intracranial haemorrhage (11% vs <2%).

 

Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial

JAMA Neurology
In THALES RCT (n=11 016 with non-cardioembolic, non-severe ischaemic stroke or high-risk TIA), ticagrelor + aspirin significantly reduced 30-day risk of disabling stroke or death vs aspirin alone (4.0% vs 4.7%; P = 0.04) and showed 23% reduction of total disability burden.

 

The assessment of venous thromboembolism risks associated with pregnancy

Healthcare Safety Investigation Branch
Following an investigation into the death of a mother who suffered a pulmonary embolism 5 weeks after the birth of her third child, this investigation will look at the assessment and communication of the risk of venous thromboembolism in pregnant and postnatal women.

 

Heparin-Induced Thrombocytopenia in Severe COVID-19

Circulation
Case study (n=7, France) reports critical COVID-19 patients develop life-threatening coagulopathy & complications that justify aggressive anticoagulation; but warn occurrence of Heparin-Induced Thrombocytopenia increases and may alter risk–benefit balance of anticoagulation.

 

Venous thromboembolism risk with JAK inhibitors: A Meta‐analysis

Arthritis and Musculoskeletal Alliance
Review of 42 studies found no increased risk, with incidence rates for VTE, PE & DVT with JAK inhibitor use of 0.68 (95%CI 0.36-1.29), 0.44 (0.28-0.70) and 0.59 (0.31-1.15) respectively. Authors state data do not support current warnings around VTE risk for JAK inhibitors.

 

Sanofi Genzyme pauses haemophilia clinical development program for fitusiran

Biospace Inc.
Program for this once-once monthly, subcutaneously dosed non-factor-replacement therapy that leverages small interfering RNA to target and decrease antithrombin has been paused to allow investigation of reports of non-fatal thrombotic events in patients in the trials.

 

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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