Anticoagulation news items. Week commencing11th May 2015
European Heart Journal
RCT (n=248; VENTURE-AF) found that use of uninterrupted rivaroxaban was feasible and bleeding and thromboembolic event rates were similar to those for uninterrupted vitamin K antagonists in patients with non-valvular atrial fibrillation undergoing catheter ablation.
European Heart Journal
In pre-specified subgroup analysis, patients randomised to lower dose edoxaban (DE) who were taking amiodarone at baseline had fewer ischaemic events compared with warfarin vs. patients not on amiodarone. Also amiodarone had no effect on relative efficacy and safety of higher DE.
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:
Anticoagulation news items. Week commencing 4th May 2015
The Lancet
In this analysis (202,417 person-yrs), a roughly 4-times increase in age-adjusted incidence and prevalence of AF in both sexes was reported. Risk of AF in both sexes doubled with each decade of age, and risk of stroke and death after diagnosis were equivalent between the sexes.
Antiplatelet therapy following transcatheter aortic valve implantation
Heart
Systematic review and pooled analysis of individual patient data (n=672) found no difference in 30-day net adverse clinical and cerebral events rate between aspirin-only or dual antiplatelet therapy following transcatheter aortic valve implantation.
Journal of the American College of Cardiology
Study (n=39,400) found low-risk patients (CHA2DS2-VASc=0 [male],1 [female]) have a truly low risk for stroke and bleeding. With 1 additional stroke risk factor (score 1 & 2 respectively), there was significant increase in event rates (particularly mortality) if non-anticoagulated.
European Heart Journal
This position paper discusses the gaps in knowledge on the effects of gender on pharmacokinetics and pharmacodynamics of cardiovascular drugs, and how such differences may influence their effectiveness and safety.
Annals of Internal Medicine
In 449 women with unexplained recurrent pregnancy loss, a daily injection of LMWH (dalteparin 5000IU) for up to 24 weeks' gestation did not improve the rate of ongoing pregnancy at 24 weeks (86.8% v 87.9%) or the live birth rate (86.0% v 86.7%) v control.
EMA approves Raplixa™ powdered fibrin sealant for surgical bleeding
European Medicines Agency
The EMA has approved Raplixa™ (fibrin sealant) for use in adults as a supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. It must be used in combination with an approved CE marked gelatin sponge (supplied separately).
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Anticoagulation news items. Week commencing 27th April 2015
British Medical Journal
A US analysis of almost 220 000 new users of dabigatran, rivaroxaban, or warfarin (2010-2013) found that risk of GI bleeding with dabigatran or rivoroxaban was similar to warfarin but risk exceeded that of warfarin with age, particularly in those over 75 years.
British Medical Journal
A US analysis (n= 46,000) found that neither dabigatran nor rivaroxaban was associated with a statistically significantly increased risk of GI bleeding relative to warfarin. However the study had wide confidence intervals and an increased risk of bleeding cannot be ruled out.
European Medicines Agency
The CHMP has adopted a positive opinion recommending approval of edoxaban (Lixiana™), for prevention of stroke and systemic embolism in adults with atrial fibrillation and for treatment and prevention of deep vein thrombosis and pulmonary embolism.
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:
Anticoagulation news items. Week commencing 20th April 2015
FDA grants priority review to Biologics License Application for idarucizumab
Biospace Inc.
Idarucizumab, a humanised antibody fragment, is being investigated to specifically reverse the anticoagulant effect of dabigatran in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.
Hospital Pharmacy
Retrospective claims analysis (n=134, rivaroxaban [RV], n=536 historical LMWH/warfarin-treated patients) found availability of RV reduced
hospitalisation rate in patients with DVT treated with RV vs. what it would have been if only LMWH/warfarin were available (60% vs. 82%).
National Institute for Health Research
No new trials were located; the review was therefore largely based on the evidence available for TA182 (TRITON-TIMI 38 trial). A new economic model confirmed prasugrel is likely to be a cost-effective treatment option when compared with clopidogrel for all subgroups 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:
Anticoagulation news items. Week commencing 13th April 2015
British Medical Journal
Meta-analysis (10 RCT's; n=32 287) found that short term DAPT (<12 months) after drug eluting stent implementation reduced bleeding with no apparent increase in ischaemic complications vs standard 12 month duration, and could be considered for most patients.
Acute Stroke Intervention: A Systematic Review
Journal of the American Medical Association
Systematic review (n = 108 082) found that IV thrombolysis remains the standard of care for patients with moderate to severe neurological deficits who present within 4.5 hours of symptom onset.
Prevalence and antithrombotic management of atrial fibrillation in hospitalised patients
Heart
US study (n=812) identified high AF prevalence rates (16.8%) across all wards. Most patients with AF were at high risk for stroke; however anticoagulation therapy was considered inappropriate in 48.7%, indicating the need for guideline optimisation especially in non-cardiac wards.
Site-Level Variation in and Practices Associated With Dabigatran Adherence
Journal of the American Medical Association
US study (n= 4863) reported wide variability in medication adherence in patients with nonvalvular AF treated with dabigatran. Pharmacist-led monitoring was associated with higher adherence rates as was pharmacist collaboration with clinicians for nonadherant patients.
National Institute for Health and Care Excellence
Discussion of a RCT which found that continuing dual antiplatelet therapy beyond 12 months after drug-eluting stent implantation reduced the risk of stent thrombosis, and major cardiovascular and cerebrovascular events at 30 months, compared with switching to 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:
http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services
Anticoagulation news items. Week commencing 6th April 2015
Biospace Inc.
The US FDA has filed an application seeking approval of dabigatran for the prophylaxis of DVT and PE in patients who have had primary elective total hip replacement surgery, based on the results of two Phase III trials (RE-NOVATE and RE-NOVATE II) comparing it to enoxaparin.
Investigational anticoagulant reversal agent (PER977) receives FDA Fast Track designation
Biospace Inc.
The FDA has granted Fast Track status for PER977, an investigational anticoagulant reversal agent that directly binds to NOACs, fondaparinux, low molecular weight heparins and unfractionated heparins. It is undergoing development as an IV injection; Phase III studies are planned.
Eyes on Evidence: Detecting atrial fibrillation in people who have had a stroke
National Institute for Health and Care Excellence
A commentary is provided on 2 RCTs which reported that long-term ECG monitoring was more effective at detecting AF than 24-hour or intermittent ECG monitoring in people who had experienced apparent cryptogenic stroke or transient ischaemic attack.
Antiphospholipid syndrome: A patient’s journey
British Medical Journal
This is last in a series of occasional articles by patients about their experiences that offer lessons to doctors. It illustrates the often long delays
experienced by patients before a diagnosis is made and treatment started.
Journal of the American Medical Association
Based on 16 trials (n=12 890) there was no difference between LMWH and unfractionated heparin in their associations with mortality, pulmonary embolism, symptomatic DVT, major bleeding, or minor bleeding outcomes in patients with cancer undergoing surgical procedures.
Practice Guide for managing a high INR in a patient on warfarin
British Medical Journal
This practice guide, based on a case vignette, outlines the immediate and long-term management of a patient presenting with a high INR whilst on
warfarin.
CADTH reviews point-of-care INR testing compared with laboratory INR testing
Canadian Agency for Drugs and Technologies in Health
This review summarises the practical impact of, and cost effectiveness of point-of-care (POC) INR testing compared with lab INR testing concluding that patient self-management (POC INR testing + dose adjustment) may be the most cost-effective option, when feasible, in Canada.
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:
Anticoagulation news items. Week commencing 30th March 2015
Stroke
Shortening door-to-needle time may lead to inadvertent intravenous thrombolysis (IVT) administration in stroke mimics (SMs). Prospective, single-centre experience (n=75) coupled with findings of meta-analysis of 9 studies suggest safety of IVT in SMs.
European Heart Journal
The article discusses dual antiplatelet therapy (DAPT), stable coronary artery disease, acute coronary syndromes, novel evidence, stent types and DAPT, rebound after DAPT cessation, and individualised DAPT management.
Cangrelor (Kengrexal™) approved in the EU for use in patients undergoing PCI
Biospace Inc.
The EC has granted marketing authorisation for cangrelor (Kengrexal™) for the reduction of thrombotic cardiovascular events in adults with coronary artery disease undergoing PCI and who have not received an oral P2Y12 inhibitor prior to the procedure.
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:
Anticoagulation news items. Week commencing 23rd March 2015
The Lancet Neurology
Pre-specified analysis (n=3017) found some early ischaemic and pre-existing signs are linked to reduced independence at 6 months and increased symptomatic intracranial haemorrhage. No interaction was noted between brain imaging signs and effects of alteplase on these outcomes.
National Institute for Health and Care Excellence
Rivaroxaban is recommended as an option within its marketing authorisation, in combination with aspirin plus clopidogrel or aspirin alone, for preventing atherothrombotic events in people who have had an acute coronary syndrome with elevated cardiac biomarkers.
British Medical Journal
US data reported that pre-procedural risk stratification was associated with an increase in the uptake of bleeding avoidance strategies (bivalirudin, radial approach, and vascular closure devices) leading to a reduction in rates of bleeding, particularly among high risk patients.
Microbleeds, Mortality, and Stroke in Alzheimer Disease: The MISTRAL Study
JAMA Neurology
This longitudinal cohort study found that microbleeds in patients with Alzheimer disease increased the risk of CV events (non-lobar bleeds) and stroke (lobar bleeds) and related mortality – even higher risks for such events were found in patients using antithrombotics.
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Anticoagulation news items. Week commencing 16th March 2015
The Lancet
This meta-analysis concluded that shorter DAPT was associated with lower all-cause mortality compared with longer DAPT (HR 0.82, 95% CI 0.69–0.98; p=0.02; NNT=325). Shorter DAPT was also associated with a lower risk of major bleeding, but a higher risk of MI and stent thrombosis.
Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction
New England Journal of Medicine
At 3 years, composite CV death, MI or stroke was reduced in the ticagrelor groups vs placebo (HR 90mg ticagrelor 0.85, 95%CI 0.75-0.96; P=0.008; HR 60mg 0.84; 0.74-0.95; P=0.004). Rates of TIMI major bleeding were higher with ticagrelor than with placebo.
The Lancet
This paper, the first in a series of three papers, discusses the pharmacological properties of the most commonly used oral antithrombotic drugs, and explores the development of antiplatelet and anticoagulant therapies.
Clinical evidence for oral antiplatelet therapy in acute coronary syndromes
The Lancet
This paper, the second in a series of three, describes major trial results for oral antiplatelet use in ACS, implications for clinical practice, and
summarises continuing controversy.
The Lancet
This paper (the third in a series of three) addresses the role of anticoagulation for stroke prevention in AF in the era of NOACs, focussing on special situations including management in the event of bleeding and around the time of procedures.
Journal of the American Medical Association
Among patients with AMI undergoing primary PCI (n=2194), the use of bivalirudin post-procedure resulted in a decrease in net adverse clinical events vs both heparin alone and heparin + tirofiban (8.8% vs 13.2% and 17% respectively, p statistically significant for both).
UKMi
This updated Medicines Q&A evaluates the evidence available on the risk of gastrointestinal bleeding with selective serotonin reuptake inhibitors.
Journal of the American Medical Association
In 1687 patients with bare metal stents who tolerated 12 months of thienopyridine, continuing thienopyridine for an additional 18 months versus placebo did not result in significant differences in rates of stent thrombosis, MACCE, or moderate or severe bleeding.
National Institute for Health and Care Excellence
Discussion of a UK GP population based randomised trial (the INTERACT trial) of people taking blood pressure and/or lipid–lowering medicines for the prevention of cardiovascular disease (CVD) which assessed the value of text messaging for medicines adherence.
Thrombolysis in acute ischaemic stroke: time for a rethink?
British Medical Journal
The authors of this article consider the use of alteplase in the management of acute stroke. They say the evidence suggests use at 3-4.5 hours after onset increases mortality with no clear benefit and believe that current recommendations should be re-evaluated urgently.
Medicines and Healthcare products Regulatory Agency
In people with certain medical conditions, these devices can give low blood coagulation results, which can lead to incorrect anticoagulant dose. This alert advises action to be taken by those working in anti-coagulation clinics and device users or their carers.
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:
Anticoagulation news items. Week commencing 9th March 2015
British Medical Journal
This research finds guideline recommendations often don't consider potential drug-drug or -disease interactions that may be present if patients have co-morbidities. The authors call for guideline developers to more explicitly account for multimorbidity in their recommendations.
Revised SPC: Plavix™ (clopidogrel) tablets
Annals of Emergency Medicine
Section 4.8 has been updated to include two new undesirable effects - acute generalised exanthematous pustulosis (very rare) and gynaecomastia (rare).
Scottish Medicines Consortium
The SMC has accepted apixaban (Eliquis) 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:
