Anticoagulation news items. Week commencing 29th September 2014
JAMA Internal Medicine
The authors of this research letter report that women, elderly patients, and those of non-white racial backgrounds are underrepresented in the RCTs of US (ACC/AHA) guidelines for AF, HF, and ACS, raising concerns about their applicability in these populations.
Journal of Clinical Oncology
The results of this study suggest that in patients with cancer treated with LMWH for 6 months for a first DVT, continuation for a further 6 months in those with residual vein thrombosis did not reduce the rate of recurrent VTE. Those without RVT at 6 months are a low risk group.
JAMA Internal Medicine
This meta-analysis of observational studies suggests that women with STEMI treated with primary PCI have a higher risk of in-hospital mortality than men; this association is likely however to be confounded by baseline CV risk factors and differences in clinical profile.
Ministry of Health, Labour and Welfare in Japan approves edoxaban for additional indications
Biospace Inc.
The oral factor Xa inhibitor edoxaban has been approved in Japan for the prevention of ischaemic stroke and systemic embolism in patients with non-valvular AF and for treatment and secondary prevention of VTE. It is currently under regulatory review in the EU for these indications.
Canadian Agency for Drugs and Technologies in Health
This article reviews current evidence of comparative efficacy and safety of monotherapy or combination medical interventions for patients with chronic thromboembolic pulmonary hypertension. Studies of riociguat, bosentan and sildenafil are summarised.
Non-adherence to cardiovascular medications
European Heart Journal
The authors of this review on non-adherence to cardiovascular medications, which is increasingly recognised, conclude that in the face of a rapidly expanding population at risk for CHD, effective means of ensuring patient adherence to evidence-based therapy are urgently needed.
All Wales Advice on the Role of Oral Anticoagulants
All Wales Medicines Strategy Group
This updated document covers the safe and effective use of oral anticoagulants for the prevention of stroke and systemic embolism in people with non-valvular AF. It considers assessment, drug choice, review, prescribing responsibility, and INR monitoring for warfarin.
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:
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Anticoagulation news items. Week commencing 22nd September 2014
Rheumatology
Meta-analysis of 6 observational studies (21,401 VTE events) noted statistically significant increased VTE risk among NSAID users (pooled risk ratio 1.80; 95% CI, 1.28, 2.52). Results should be interpreted with caution due to observational nature of studies and other limitations.
Circulation
Analysis of data on 44,410 patients with ischaemic stroke treated with IV tPA found those with CKD had higher risk of symptomatic intracranial or serious systemic haemorrhage, but presence of renal impairment not independently linked to these major complications of IV tPA use.
National Institute for Health and Care Excellence
In this guidance, NICE recommends the use of two point-of care coagulometers (CoaguChek XS and InRatio2 PT/INR) for patients on long term vitamin K antagonist therapy who have AF or heart valve disease, provided they or their carer are able to self monitor effectively.
Electronic Medication Packaging Devices and Medication Adherence: A Systematic Review
Journal of the American Medical Association
This review of 37 studies of electronic medication packaging devices (adherence-monitoring devices incorporated into the packaging of a prescription medication) concluded that higher quality evidence is needed to determine the effects of these interventions on non-adherence.
2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes
Circulation
This is a full revision of the 2007 guideline for the management of unstable angina and NSTEMI. It incorporates both established and new evidence from published clinical trials, as well as information from basic science and comprehensive review articles.
Circulation
This scientific statement provides an overview of the post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis, and offers practical recommendations for its optimal prevention, diagnosis, and management.
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:
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Anticoagulation news items. Week commencing 15th September 2014
Journal of the American Medical Association
Analysis found no differences in efficacy/safety with most treatment strategies used to treat VTE compared with the LMWH–vitamin K antagonist, except UFH–vitamin K antagonist which was associated with an increased rate of recurrent VTE.
National Institute for Health and Care Excellence
A Danish observational study found that adding antiplatelet therapy (aspirin, clopidogrel or both) to anticoagulant treatment with a vitamin K antagonist such as warfarin, was not associated with a reduced risk of recurrent coronary events or of thromboembolism, but was associated with increased bleeding.
National Institute for Health and Care Excellence
A Spanish study found a wide range of views among patients and physicians on the acceptable trade-off between a reduction in risk of stroke and an increased risk of bleeding in atrial fibrillation.
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:
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Anticoagulation news items. Week commencing 8th September 2014
European Heart Journal
This review summarises the current knowledge of the management of antithrombotic therapy after valve replacement, paying particular attention to persisting gaps in knowledge.
British Journal of Haematology
This guideline on the clinical effectiveness and health economics of patient self-testing and self-management of oral anticoagulant therapy updates a previous guideline published in 2005.
British Journal of Haematology
This article provides guidance on the clinically important issues regarding the laboratory assessment of non-coumarin anticoagulants (new oral anticoagulants; heparins, bivalirudin; fondaparinux; argatroban; danaparoid) and their impact on laboratory tests of haemostasis.
British Medical Journal
This US study of patients undergoing inpatient or outpatient surgical procedures found that the presence of preoperative systemic inflammatory response syndrome or any sepsis was associated with an increased risk of an arterial or venous thrombosis post-surgery (odds ratio 3.1).
Interventions for treating acute bleeding episodes in people with acquired hemophilia A
Cochrane Database of Systematic Reviews
No randomised clinical trials of haemostatic therapies for acquired hemophilia A were found thus, no recommendations can be made on the optimal haemostatic therapies based on the highest quality of evidence.
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:
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Anticoagulation news items. Week commencing 1st September 2014
Revised SPC: Xarelto (rivaroxaban) 10mg film-coated tablets
electronic Medicines Compendium
Details of an open-label cohort study (XAMOS) have been added to section 5.1; the results of this were consistent with the results of the pivotal randomised studies.
Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation
European Heart Journal
This descriptive study in patients with AF undergoing elective cardioversion reports that rivaroxaban is similar to warfarin in terms of efficacy (stroke, TIA, peripheral embolism, MI or CV death in 0.51% and 1.02%, respectively) and safety (major bleeding in 0.6% and 0.8%).
Prehospital Ticagrelor in ST-Segment Elevation Myocardial Infarction
New England Journal of Medicine
This international double-blind study found that pre-hospital administration of ticagrelor (in the ambulance) appeared to be safe, but did not improve outcomes when compared to later administration in hospital in patients with ST-segment elevation myocardial infarction.
2014 ESC Guidelines on the diagnosis and management of acute pulmonary embolism
European Heart Journal
These updated guidelines on the clinical management of PE consider new data that have extended or modified knowledge in respect of optimal diagnosis, assessment and treatment. New aspects covered include new oral anticoagulants and outpatient treatment, among others.
European Heart Journal
This analysis of a contemporary European registry of AF patients (n=3119) found overall oral anticoagulant use remains high (around 78% at one year). One-year mortality however remains high (5.7%; 70% cardiovascular deaths), and hospital readmissions were common.
Management of venous thrombo-embolism: an update
European Heart Journal
This article reviews recent advances in the management of venous thromboembolism, including risk stratification, use of new oral anticoagulants in treatment and secondary prophylaxis, and the potential transition of acute VTE to chronic thromboembolic pulmonary hypertension.
Biospace
The results of a multinational disease registry designed to explore AF management in clinical practice show 80% were receiving oral anticoagulants after one year, with an increase in the proportion prescribed new oral anticoagulants (12.6%; up from 6.1% the previous year).
European Heart Journal
In large population of non-anticoagulated AF patients, the pattern of AF (paroxysmal, persistent, or permanent) was a strong independent predictor of stroke risk and may be helpful to assess risk/benefit for anticoagulant therapy, especially in lower risk patients.
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:
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Anticoagulation news items. Week commencing 25th August 2014
European Heart Journal
This updated joint consensus document discusses the optimal antithrombotic therapy management in AF patients presenting with ACS and/or undergoing percutaneous coronary or valve interventions and provides recommendations for use in clinical practice.
Aspirin for the Prevention of Recurrent Venous Thromboembolism: The INSPIRE Collaboration
Circulation
This individual-patient-data analysis of the WARFASA and ASPIRE trials found low-dose aspirin for extended treatment of VTE reduced recurrent VTE (5.1% vs. 7.5%/yr with placebo) and major vascular events (5.7% vs. 8.7%/yr). The rate of major bleeding was low (0.5% vs. 0.4%/yr).
JAMA Internal Medicine
This article reports on two patients with predominantly hepatocellular liver injury that occurred during treatment with rivaroxaban. Both had massively elevated transaminase activity levels and hyperbilirubinaemia, and fulfilled the criteria of Hy's law.
Medicines and Healthcare products Regulatory Agency
MHRA has responded to an article raising concerns about trial data for alteplase in ischaemic stroke. Although European regulators have concluded the benefit: risk balance is favourable, an expert working group will be set up to ensure all relevant evidence has been considered.
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 18th August 2014
PLATO study of ticagrelor for ACS gets all clear from US
PharmaTimes
The US Department of Justice has closed its investigation into the phase III PLATO trial which formed the basis for regulatory approval of ticagrelor (Brilique™ in UK) for acute coronary syndrome.
JAMA Internal Medicine
This US retrospective study found no statistically significant difference in VTE rates within 90 days of admission in medical patients between hospitals with low, moderate or high use of pharmacological VTE prophylaxis.
Revised SPCs: Xarelto (rivaroxaban) 10mg, 15mg and 20mg film-coated tablets
electronic Medicines Compendium
Information on converting from parenteral anticoagulants to rivaroxaban has been added to section 4.2 (posology and method of administration).
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. Weeks commencing 4th and 11th August 2014
UKMi
This Medicines Q&A evaluates the evidence for using low molecular weight heparins for the prevention of travel-related venous thromboembolism
Update on Chronic Thromboembolic Pulmonary Hypertension
Circulation
This review on thromboembolic pulmonary hypertension covers epidemiology and definition, mechanisms of disease, clinical characteristics, diagnostic procedures, and treatment.
MHRA launches learning module on oral anticoagulants
Medicines and Healthcare products Regulatory Agency
The MHRA has launched an online learning module for healthcare professionals outlining the key risks of oral anticoagulants. The module includes a description of important adverse effects, factors that increase their risk, how risk can be reduced, and specific treatments.
The Lancet
This meta-analysis of individual patient data from 9 RCTs of alteplase for acute ischaemic stroke found that it improved the odds of a good stroke outcome versus control when given within 4.5 hours, with proportional treatment benefits similar regardless of age or stroke severity.
Heart
This analysis of European registry data found that 10.9% of patients with AF were treated with a combination of oral anticoagulant and one or two antiplatelets. The majority of those on dual (95%) or triple (64%) combination therapy did not have an accepted indication.
Perioperative Atrial Fibrillation and the Long-term Risk of Ischemic Stroke
Journal of the American Medical Association
Among patients hospitalised for surgery, perioperative AF was linked to increased long-term risk of ischaemic stroke. More studies are needed to better delineate the risk and determine optimal antithrombotic strategies in such patients with other risk factors for 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
Anticoagulation news items. Week commencing 28th July 2014
JAMA Internal Medicine
Among 90,618 patients hospitalised for DVT, 3649 underwent catheter-directed thrombolysis (CDT). No difference was found in mortality between CDT and anticoagulation groups (1.2% vs. 0.9%; OR, 1.40; 95% CI, 0.88-2.25; p=0.15).but more adverse events noted in the CDT group.
British Medical Journal
The QBleed risk algorithms were found to provide valid measures of absolute upper gastrointestinal and intracranial bleed risk in new users of anticoagulants (versus non-users), and were validated by a separate validation cohort, with some advantages over other scoring methods.
JAMA Neurology
This article reviews the definitions and epidemiologic characteristics of symptomatic intracerebral haemorrhage, with a focus on the rationale and options for treatment.
Revised SPC: Eliquis (apixaban) 2.5mg and 5 mg film-coated tablets
electronic Medicines Compendium
Apixban is now also licensed for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
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:
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Anticoagulation news items. Week commencing 21st July 2014
The Lancet
Antepartum prophylactic dalteparin did not reduce occurrence of VTE, pregnancy loss, or placenta-mediated pregnancy complications in pregnant women with thrombophilia at high risk of these complications and was associated with an increased risk of minor bleeding (n=289).
BMJ investigation alleges that Boehringer Ingelheim withheld safety analyses of dabigatran
British Medical Journal
According to an investigation by the BMJ, Boehringer Ingelheim withheld from doctors and drug regulators the fact that monitoring the blood level of dabigatran and adjusting the dose could substantially reduce major bleeds associated with it.
National Institute for Health and Care Excellence
Prasugrel in combination with aspirin is recommended as an option for preventing atherothrombotic events in adults with acute coronary syndrome (unstable angina, non-ST or ST segment elevation myocardial infarction) having primary or delayed percutaneous coronary intervention.
Catheter ablation of atrial fibrillation: an update
European Heart Journal
Recent clinical trial data have demonstrated the superiority of catheter ablation of AF to antiarrhythmic drug therapy in controlling AF. However, it is a challenging and complex procedure and therefore not used as a first line treatment option in clinical practice.
Antiplatelet therapy for secondary prevention of coronary artery disease
Heart
This review summarizes the currently available evidence on choice, combination and duration of antiplatelet agents in stable coronary artery disease and acute coronary syndrome.
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
