Anticoagulation news items. Weeks commencing 7th December 2015
BMJ Open
Service was delivered in 56 GP practices. Eligible patients on anticoagulation improved from 77% to 95% (p<0.0001). Audit of 8 practices after 195 days showed 90% continued treatment; ~30–35 strokes/year may have been prevented in these previously under-treated high-risk patients.
British Medical Journal
Study of 465,918 Medicare fee for service beneficiaries noted a substantial positive link between use of warfarin (WF) with glipizide/glimepiride and hospital admission/emergency department visits for hypoglycemia and related diagnoses, particularly in patients first starting WF.
The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation
European Heart Journal
In this report of a validation of a new risk-scoring tool to assess bleeding risk in patients with AF, it is claimed that the five-element ORBIT bleeding risk score had better ability to predict major bleeding than either HAS-BLED and ATRIA risk scoring tools.
A Multinational Trial of Prasugrel for Sickle Cell Vaso-Occlusive Events
New England Journal of Medicine
In this RCT, 341 patients with sickle cell anaemia (aged 2 – 17) were randomised to receive prasugrel or placebo. At the end of the trial no significant differences were seen in the primary end-point of vaso-occlusive crises (2.30 vs 2.77 per patient per year).
The Lancet Haematology
In this real-life comparison of outcomes in patients receiving rivoroxaban (RV) (n=2619) or standard anticoagulation (n=2149) it was reported that although RV patients had a lower baseline risk, adjusted analyses show it to be a safe and effective alternative to standard treatment.
Oral antiplatelet agents – are they safe in breastfeeding?
UKMi
This updated medicines Q&A provides advice on the safety of oral antiplatelet agents in breastfeeding mothers.
European Heart Journal
This expert opinion paper reviews the evidence and benefit and risk balance for antithrombotic therapy in the older age group and makes recommendations for maximising benefits and minimising risks.
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 30th November 2015
Heart failure and risk of venous thromboembolism: a systematic review and meta-analysis
The Lancet Haematology
Review of 71 studies found heart failure is a common independent risk factor for venous thromboembolism, with overall relative risk of 1.51 (1.36–1.68). Researchers suggest thromoboprophylaxis should be considered in clinical practice for high-risk patients.
British Medical Journal
The device has been subject to recall following reports it could deliver INR results "clinically significantly lower" vs. laboratory INR method. This could have made rivaroxaban appear safer in terms of bleeding risk. European Medicines Agency has launched investigation.
UKMi
This new Medicines Q&A examines the risks of using antiplatelet medicines in combination with oral anticoagulants and how these risks may be managed.
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 9th, 16th and 23rd November 2015
edoxaban (Lixiana) for the prevention of stroke and systemic embolism
Scottish Medicines Consortium
The SMC has accepted for use within NHS Scotland, edoxaban (Lixiana®) for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as CHF, hypertension, age ≥75 years, DM, prior stroke or TIA.
edoxaban (Lixiana) for the treatment of DVT and PE
Scottish Medicines Consortium
The Scottish Medicines Consortium has accepted for use within NHS Scotland, edoxaban (Lixiana®) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
US Food and Drug Administration
This review stated that long-term use (12 months or longer) of clopidogrel does not increase or decrease overall risk of death in patients with, or at risk for, heart disease. The evaluation also does not suggest that clopidogrel increases the risk of cancer or death from cancer.
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 2nd November 2015
British Medical Journal
Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were linked to reduced risk of target lesion revascularisation, major adverse cardiac events, and reduced late lumen loss.
The Lancet
Trial was terminated early after enrolment of 3232 patients due to severe allergic reactions with reversible factor IXa inhibitor REG1, as currently formulated. Although statistical power was limited, there was no evidence REG1 reduced ischaemic events/bleeding vs. bivalirudin.
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 26th October 2015
Circulation
Trial (n=187 on warfarin and 187 matched controls) found no significant survival advantage was observed in patients on warfarin. In patients with PAH linked to systemic sclerosis, long-term warfarin was associated with poorer survival than in patients not on warfarin.
The Lancet
RCT (n=1498) found patient-oriented endpoint occurred in 159 (21%) patients in the everolimus-eluting stents group vs. 192 (26%) in the bare-metal stents group (HR 0.80, 95% CI 0.65–0.98; p=0.033). This difference was mainly driven by a reduced rate of all-cause mortality.
Cochrane Database of Systematic Reviews
The combined data from recent RCTs have shown no statistically significant differences between these interventions in prevention of recurrent ischaemic stroke.
Treatment and Outcome of Thrombolysis-Related Hemorrhage: A Multicenter Retrospective Study
JAMA Neurology
This US study of 128 patients with symptomatic intracerebral haemorrhage following thrombolysis for ischaemic stroke reports a median time to diagnosis of 470 minutes and highlights a role for cryoprecipitate in reversing recombinant tissue plasminogen activator coagulopathy.
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 19th October 2015
Revised SPC: Fibrogamin (blood coagulation factor XIII) 250/1250IU
electronic Medicines Compendium
Fibrogammin is now licensed for use in paediatric patients. The initial dose in congenital Factor XIII deficiency has been increased to 40 units per kg every 28 days, in both adult and paediatric patients.
British Medical Journal
This large retrospective study found patients taking PPIs in addition to NSAID plus antithrombotics after MI had a lower risk of GI bleeding vs NSAID plus antithrombotics without PPI (1.8 vs 2.1 events per 100 person years; HR 0.72 95% CI = 0.54 to 0.95).
US Food and Drug Administration
In healthy volunteers (n=283) given idarucizumab there was an immediate reduction in the amount of unbound dabigatran plasma lasting at least 24 hours. In another trial (n=123) dabigatran was fully reversed in 89% of patients within four hours of receiving idarucizumab.
British Medical Journal
This review provides a comprehensive account of the pathophysiology, clinical presentation, management, and outcomes of acute coronary syndrome.
Drug problems: Dangerous decision-making at the FDA
Project on Government Oversight
This independent report alleges that the US FDA lowered its standards to ease approval of dabigatran and then deflected questions about its safety that arose after the drug entered clinical practice.
US Food and Drug Administration
Coagadex, which is derived from human plasma, is indicated for patients aged ≥12 years with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, and for perioperative management of bleeding in patients with mild hereditary Factor X deficiency.
Circulation: Arrhythmia and Electrophysiology
Meta-analysis of 7 studies found stroke prevention with NOACs is superior to warfarin in patients with nonvalvular atrial fibrillation; and the Watchman left atrial appendage occlusion device was considered a reasonable noninferior alternative to 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:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Anticoagulation news items. Weeks commencing 12th October 2015
Revised SPC: Eliquis (apixaban) film-coated tablets
electronic Medicines Compendium
Information regarding the use of alternative methods of administration of apixaban tablets (crushed tablets) has been added to sections 4.2 and 5.2. Recommendations on use of prothrombin complex concentrates to reverse its anticoagulant effect have been added to 4.9.
Riociguat (Adempas®) for chronic thromboembolic pulmonary hypertension
All Wales Medicines Strategy Group
Riociguat is recommended for use in NHS Wales for treatment of adults with WHO class II- III inoperable chronic thromboembolic pulmonary hypertension (CTEPH); or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity providing PAS is utilised.
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 5th October 2015
European Heart Journal
Although the relative benefits of ticagrelor were similar in patients with reduced renal function (eGFR<60mL/min), absolute benefits were higher as their risk of major adverse CV events was higher. There was however an excess of minor bleeding events.
Cardiovascular Management in Pregnancy: Antithrombotic Agents and Antiplatelet Agents
Circulation
This article reviews the use of anticoagulants and antiplatelets during pregnancy and highlights their clinical utility in conditions including VTE, thrombophilias, mechanical heart valves, APLS, pre-eclampsia, intrauterine growth restriction, and placental abruption.
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 28th September 2015
National Institute for Health Research
In immobile patients with stroke, use of intermittent pneumatic compression (IPC) was associated with a reduced incidence of DVT within 30 days of randomisation (8.5% vs 12.1% with no IPC, absolute reduction in risk of 3.6%; estimated cost of £1,282 per event prevented).
Annals of Internal Medicine
This report presents an evidence-based and high-value diagnostic strategy for the diagnosis of pulmonary embolism, to help clinicians understand the potential hurdles to such an approach and outline performance improvement strategies to overcome them.
Circulation
In this study, the use of sulodexide following discontinuation of anticoagulant therapy in patients with a first unprovoked VTE reduced the incidence of VTE recurrence (15/307 versus 30/308 with placebo; HR 0.49, 95% CI 0.27-0.92; P=0.025); adverse events were similar.
Open Heart
Meta-analysis of 19 trials (n=35,596) found that bivalirudin increases risk of acute stent thrombosis (ST) in STEMI, but may confer an advantage over unfractionated heparin in NSTE- acute coronary syndromes while undergoing PCI, reducing major bleeding without an increase in ST.
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 21st September 2015
European Medicines Agency
Idarucizuma is a specific reversal agent for dabigatran and is intended for use in adults when rapid reversal is required for emergency surgery/urgent procedures; or in life-threatening or uncontrolled bleeding. It is proposed that use be restricted to hospital only.
National Institute for Health and Care Excellence
NICE recommends the use of edoxaban as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors. The decision about whether to start treatment with edoxaban should be made after an informed discussion.
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
