Anticoagulation news items. Week commencing 23rd November 2020
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.
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
Anticoagulation news items. Week commencing 16th November 2020
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 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).
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
Anticoagulation news items. Week commencing 9th November 2020
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.
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%).
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
Anticoagulation news items. Week commencing 2nd November 2020
JAMA Cardiology
Study (n=2191) found higher coronary artery calcium (CAC) is associated with atherosclerotic cardiovascular disease (CVD) & bleeding events. High CAC score denotes net benefit from aspirin for primary prevention, but only in setting of lower bleeding, and intermediate CVD risk.
Antithrombotic therapy for patients with chronic coronary syndromes
Heart
Review evaluates the pathophysiology and pharmacology of atherothrombosis, highlights current RCT evidence and discusses the content and application of the European Society of Cardiology 2019 chronic coronary syndromes guidelines.
Kent Surrey Sussex Academic Health Science Network (KSS AHSN)
The tool used in this project, assisted GP practices with complete management of patients with AF; generating lists of diagnosed AF patients where clinical intervention is missing along with opportunistic prompts (aligned to AF NICE CG180 guidelines).
Diagnosis and Treatment of Lower Extremity Venous Thromboembolism
Journal of the American Medical Association
This review summarises recent developments in the diagnosis and management of lower extremity deep vein thrombosis, including discussion of risk factors, clinical presentation, and risks for pulmonary embolism and other complications.
Prophylactic anticoagulants for people hospitalised with COVID‐19
Cochrane Database of Systematic Reviews
Review of 7 studies (n=5929) concludes there is insufficient evidence to determine risks and benefits of prophylactic anticoagulants for people hospitalised with COVID‐19. There are 22 studies in >15,000 participants underway however, which will provide more robust evidence.
Cochrane Database of Systematic Reviews
Review of 23 non-randomised studies (no RCTs were appropriate for inclusion) concludes it is unclear from the available evidence if thromboprophylaxis used for adults with ALL treated with asparaginase is associated with any appreciable benefits or harms.
BMJ Open
Study (n=4,846) found a low rate of major bleeding in gastrointestinal, intracranial and urogenital sites when using rivaroxaban for treatment of deep vein thrombosis/pulmonary embolism (<1% for all). Authors report this magnitude of risk is consistent with trial data.
Circulation
Review of the VOYAGER PAD trial found rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events irrespective of clopidogrel use. Safety was also consistent regardless of clopidogrel, but with a trend for more major bleeding with clopidogrel use >30 days.
JAMA Neurology
Meta-analysis (n=270) found that reperfusion was associated with significantly improved functional outcome without increased risk of symptomatic haemorrhage support when used between 4.5 to 9-hours post stroke (SPC recommends treatment within 4.5 hours of stroke).
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
