Acute coronary syndrome - rivaroxaban [ID532]: consultation document

National Institute for Health and Care Excellence

DRAFT guidance recommends rivaroxaban as option, in combination with aspirin plus clopidogrel/aspirin alone, for preventing atherothrombotic events in people who have had an ACS with elevated cardiac biomarkers. Risk of bleeding should be assessed before treatment is started.

 

Chronic vitamin K antagonist therapy and bleeding risk in ST elevation myocardial infarction patients

Heart

In patients with STEMI treated with primary PCI, chronic use of vitamin K antagonist (VKA) was associated with an increased risk of in-hospital major bleed (17.0% v 10.1% in those not on VKA). In those on VKA, glycoprotein inhibitors were associated with increased bleeding risk.

 

New product: Nuwiq (human coagulation factor VIII, simoctocog alfa)

electronic Medicines Compendium

Nuwiq is licensed for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Dose and duration depend on the severity of the factor VIII deficiency, location and extent of the bleeding and the patient's clinical condition.

 

 

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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New product: Xarelto (rivaroxaban) 2.5 mg film-coated tablets

electronic Medicines Compendium
Rivaroxaban co-administered with aspirin alone or with aspirin plus clopidogrel or ticlopidine, is indicated for prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.

 

Guideline for the diagnosis and management of the rare coagulation disorders

British Journal of Haematology
This guideline covers the diagnosis and management of patients with rare coagulation disorders, defined as monogenic bleeding disorders caused by deficiency of a soluble coagulation factor or factors, other than von Willebrand disease, Haemophilia A or Haemophilia B.

 

dabigatran etexilate (Pradaxa)

Scottish Medicines Consortium
The SMC has accepted dabigatran etexilate (Pradaxa®) for use within NHS Scotland for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Cost-effectiveness of longer-term use (>18 months) is uncertain.

 

 

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 in adults with congenital heart disease: The who, the when and the how?

Heart

This article reviews the current use of anticoagulation in patients with congenital heart disease. It discusses treatment and monitoring with warfarin, heparin and the new oral anticoagulants, and who and when to treat.

 

Medicines Evidence Commentary : Acute coronary syndromes: duration of dual antiplatelet therapy after drug-eluting stent implantation

National Institute for Health and Care Excellence

A randomised controlled trial reported that continuing dual antiplatelet therapy beyond a year after stent implantation did not statistically significantly reduce the risk of the combined outcome of death or cardiovascular events compared with continuing aspirin monotherapy....

 

 

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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Underrepresentation of Women, Elderly Patients, and Racial Minorities in the Randomized Trials Used for Cardiovascular Guidelines

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.

 

Optimal Duration of Low Molecular Weight Heparin for the Treatment of Cancer-Related Deep Vein Thrombosis: The Cancer-DACUS Study

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.

 

Sex Differences in Short-term and Long-term All-Cause Mortality Among Patients With ST-Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Intervention: A Meta-analysis

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.

 

Drug Therapy for Chronic Thromboembolic Pulmonary Hypertension: A Review of the Comparative Clinical Effectiveness

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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Non-steroidal anti-inflammatory drugs and risk of venous thromboembolism: a systematic review and meta-analysis

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.

 

Chronic Kidney Disease and Bleeding Complications After Intravenous Thrombolytic Therapy for Acute Ischemic Stroke

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.

 

Atrial fibrillation and heart valve disease: self monitoring coagulation status using point of care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) – guidance (DG14)

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.

 

The Postthrombotic Syndrome: Evidence-Based Prevention, Diagnosis, and Treatment Strategies: A Scientific Statement From the American Heart Association

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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Clinical and Safety Outcomes Associated With Treatment of Acute Venous Thromboembolism: A Systematic Review and Meta-analysis

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.

 

Medicines Evidence Commentary : Antithrombotic treatment for people with atrial fibrillation and stable coronary artery disease

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.

 

Medicines Evidence Commentary : Atrial fibrillation : differences among patients and physicians in values and preferences about antithrombotic choice

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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The optimal management of anti-thrombotic therapy after valve replacement: certainties and uncertainties

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.

 

Patient self-testing and self-management of oral anticoagulation with vitamin K antagonists: guidance from the British Committee for Standards in Haematology

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.

 

Measurement of non-Coumarin anticoagulants and their effects on tests of Haemostasis: Guidance from the British Committee for Standards in Haematology

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.

 

Impact of sepsis on risk of postoperative arterial and venous thromboses: large prospective cohort study

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

 

 

 

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.

 

Prognosis and treatment of atrial fibrillation patients by European cardiologists: One Year Follow-up of the EURObservational Research Programme-Atrial Fibrillation General Registry Pilot Phase (EORP-AF Pilot registry)

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.

 

One year data from the PREFER in AF European registry show changes in management and implementation of guidelines

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).


Risk of ischaemic stroke according to pattern of atrial fibrillation: analysis of 6563 aspirin-treated patients in ACTIVE-A and AVERROES

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

 

 

Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a European consensus document

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).

 

Symptomatic Hepatocellular Liver Injury With Hyperbilirubinemia in Two Patients Treated With Rivaroxaban

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.

 

MHRA responds to article in the Lancet that questions the authorisation of alteplase for acute ischaemic stroke

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:
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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.

 

Hospital Performance for Pharmacologic Venous Thromboembolism Prophylaxis and Rate of Venous Thromboembolism: A Cohort Study

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