Efficacy and safety of apixaban compared with aspirin in patients who previously tried but failed treatment with vitamin K antagonists: results from the AVERROES trial

European Heart Journal

In this prespecified analysis, the efficacy and safety of apixaban compared with aspirin was consistent in subgroups of patients who had previously attempted but failed vitamin K antagonist therapy (n=2216), irrespective of the reason for discontinuation.

 

Nonsteroidal Anti-Inflammatory Drugs and the Heart

Circulation

This evidence based review discusses the mechanisms underlying the cardiovascular effects of traditional NSAIDs and coxibs.

 

Sentinel Stroke National Audit Programme (SSNAP) clinical audit, July - September 2013 public report

Royal College of Physicians

This report finds that huge improvements have been made in the quality of stroke care and services over the past years as measured by previous national stroke audits and it is anticipated that similar improvements will be demonstrated through future SSNAP quarterly reports.

 

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: Pletal (cilostazol) 50 mg and 100 mg tablets

Electronic Medicines Compendium

Indication restricted to 2nd line use. 4.2: specialist initiation/review after 3 months. 4.2, 4.4 & 4.5: Reduce dose to 50mg BD if with strong CYP3A4 inhibitors 4.3 & 4.4: New contraindications and warnings, including concomitant use with 2 or more anticoagulants/antiplatelets.

 

Revised SPC: Plavix (clopidogrel) 75mg and 300mg tablets

Electronic Medicines Compendium

The SPC has been updated with warning about increased risk of bleeding with concomitant use of SSRIs and clopidogrel.

 

Outcomes of Temporary Interruption of Rivaroxaban Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation: Results from ROCKET AF

Circulation

Risk of a Thrombotic Event after the 6-Week Postpartum Period Analysis of ROCKET AF trial (n=14,236) found that temporary interruptions (3-30 days) of oral anticoagulation is common and associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin.

 

Risk of a Thrombotic Event after the 6-Week Postpartum Period

New England Journal of Medicine

This US study (n=1,687,930;1015 thrombotic events) reported elevated thrombosis risk that persisted until at least 12wks post delivery, though absolute risk increase after 6wks was low. Risks/benefits of continuing treatment for high-risk women after 6 wks require investigation.

 

Dabigatran (Pradaxa) lawsuits in US due to start in August

NewsDaily

US courts are scheduled to start hearing cases in August against Boehringer Ingelheim, who is facing more than 2000 lawsuits over claims that dabigatran caused severe and fatal bleeding. Claimants accuse Boehringer of not having sufficiently warned of these risks.

 

Treatment of Venous Thromboembolism

Journal of the American Medical Association

This review of the aetiology of VTE and the 3 phases of VTE treatment (acute, long-term and extended) concludes that further study to understand individual patient risks is needed to make ideal treatment decisions.

 

How effective is tranexamic acid for acute gastrointestinal bleeding?

British Medical Journal

This article on tranexamic acid for the treatment of acute GI bleeding is one of a series that highlight areas of practice where management lacks convincing supporting evidence. The authors discuss the available evidence and make recommendations, in light of the uncertainty.

 

Drug Safety Update: Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small

Medicines and Healthcare products Regulatory Agency

A review of the latest evidence on the risk of thromboembolism in association with combined hormonal contraceptives (CHCs) has concluded that the risk of blood clots with all low dose CHCs is small and the benefits of CHC far outweigh the risk of serious side effects.

 

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

 

 

Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in patients with atrial fibrillation

This analysis estimates that apixaban has an incremental cost-effectiveness ratio of £11,909 per QALY gained compared with warfarin (in VKA suitable patients) and £7,196 per QALY gained compared with aspirin (in VKA unsuitable patients) for stroke prevention in AF. This analysis estimates that apixaban has an incremental cost-effectiveness ratio of £11,909 per QALY gained compared with warfarin (in VKA suitable patients) and £7,196 per QALY gained compared with aspirin (in VKA unsuitable patients) for stroke prevention in AF.

http://eurheartj.oxfordjournals.org/content/early/2014/02/07/eurheartj.ehu006.abstract

 

Guidelines for the Prevention of Stroke in Women: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association

This statement summarises data on stroke risk factors that are unique to (reproductive factors) and more common (migraine with aura, obesity, metabolic syndrome, and AF) in women than men, and expands on data provided in prior guidelines for women.

http://stroke.ahajournals.org/content/early/2014/02/06/01.str.0000442009.06663.48.abstract

 

Meta-Analysis of Risk of Stroke or Transient Ischemic Attack With Dabigatran for Atrial Fibrillation Ablation

A meta-analysis (18 observational studies; n= 5513) found that dabigatran during AF ablation is associated with a higher risk of thromboembolic complications compared to warfarin (16 vs 7 events; OR 2.81, 95% CI 1.23 to 6.45) with no significant differences for major bleeding.

http://www.sciencedirect.com/science/article/pii/S0002914914000538

 

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

 

 

Direct oral anticoagulants in the treatment and long-term prevention of venous thrombo-embolism 

This article reviews direct oral anticoagulants (e.g. apixaban, dabigatran and rivaroxaban) under the following topic headings: Acute and long-term treatment of VTE; Extended treatment of VTE; Lessons from the developmentprogrammes for these drugs; and practical considerations.

http://eurheartj.oxfordjournals.org/content/early/2014/02/06/eurheartj.ehu027.abstract

 

Peroxisome proliferator-activated receptor gamma agonists for preventing recurrent stroke and other vascular events in patients with stroke or transient ischaemic attack

PPAR- agonists were found to reduce recurrent stroke and total events of CV death, non-fatal MI or non-fatal stroke, and improve insulin sensitivity and stabilisation of carotid plaques, but findings should be interpreted cautiously due to small number and quality of the studies.

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010693.pub2/full

 

Point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) in people on long-term vitamin K
antagonist therapy who have atrial fibrillation or heart valve disease: diagnostics consultation document

Draft guidance from NICE's Diagnostics Assessment Programme on two technologies for self-monitoring the clotting of blood in people on long term anticoagulation therapy has been issued for public consultation.

http://www.nice.org.uk/nicemedia/live/14091/66497/66497.pdf

 

Aspirin versus vitamin K antagonist treatment guided by transoesophageal echocardiography in patients with atrial fibrillation: a pilot study

The results of this study (n=238) suggest that transoesophageal echocardiography (TEE) may help to refine stroke risk and guide antithrombotic treatment choice (VKA or aspirin) in patients with paroxysmal atrial fibrillation. Further research is however required.

http://heart.bmj.com/content/early/2014/01/30/heartjnl-2013-305017.abstract

 

Ultrasound-assisted thrombolysis for acute pulmonary embolism: a systematic review

The authors of this review discuss catheter-based revascularisation for PE and ultrasound-assisted thrombolysis and present and discuss the results of seven studies (n=197) of ultrasound-assisted catheter-directed thrombolysis (CDT) for PE (only one small RCT).

http://eurheartj.oxfordjournals.org/content/early/2014/02/03/eurheartj.ehu029.abstract

 

Media hype blood clot risk of birth control pills

This 'Behind the Headlines' assessment discusses the risk of venous thromboembolism associated with use of combined oral contraceptives
(following the recent European review) and comments that the UK media overhyped the potential risk in their reporting.

http://www.nhs.uk/news/2014/02February/Pages/Media-hype-blood-clot-risk-of-birth-control-pills.aspx

 

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

 

 

Antiplatelet Therapy for Stable Coronary Artery Disease in Atrial Fibrillation Patients on Oral Anticoagulant: A Nationwide Cohort Study

This study of 8,700 patients with AF and stable CAD (>12 months from an acute event) found combined vitamin K antagonist (VKA) plus antiplatelet was not associated with a reduced risk of MI/coronary death or thromboembolism vs. VKA monotherapy, but bleeding risk was increased.

http://circ.ahajournals.org/content/early/2014/01/27/CIRCULATIONAHA.113.004834.abstract

 

Risk of drug-induced liver injury with the new oral anticoagulants: systematic review and meta-analysis

This analysis of 29 RCTs (n=152,116, mean follow-up 16 months) found that NOACs were not linked to increased risk of drug-induced liver injury (RR 0.90, 95% CI, 0.72 to 1.13, I2=0%). Similar results were obtained for individual NOACs.

http://heart.bmj.com/content/early/2014/01/29/heartjnl-2013-305288.abstract

 

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 for diclofenac.
The SPCs have been updated with warnings about the CV risks of diclofenac, which may increase with dose and duration of exposure. Patients with significant risk factors for CV events should only be treated with diclofenac after careful consideration; and reviewed regularly.
http://www.medicines.org.uk/emc/medicine/1342/SPC/Voltarol%20Tablets/

Prasugrel (Efient): increased risk of bleeding – information on timing of loading dose.

New trial data are available on timing of prasugrel loading dose when used in patients with unstable angina or NSTEMI. In these patients, when coronary angiography is done within 48 hours after admission, loading dose should only be given at time of PCI to minimise bleeding risk.
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON364156

Warfarin use and the risk for stroke and bleeding in patients undergoing dialysis.
This Canadian retrospective cohort study (n=1626 dialysis, n=204,210 non-dialysis, ≥65 years, admitted to hospital with AF) found that in patients with AF undergoing dialysis, warfarin was not beneficial in reducing stroke risk but was associated with a higher bleeding risk.
http://circ.ahajournals.org/content/early/2014/01/22/CIRCULATIONAHA.113.004777.abstract


Combined hormonal contraceptives: Europe-wide review confirms the risk of thromboembolism is small and agrees updated information to reflect the latest evidence.
The Europe-wide review concluded that the risk of blood clots with all CHCs is small and the benefits of any CHC far outweigh the risk of serious side effects. There is good evidence that the risk of VTE may vary between products, depending on the progestogen.
https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102106

Optimal duration of dual anti-platelet therapy after drug-eluting stent implantation: A randomised, controlled trial.
This study (n=5045) reported that at 24 months following randomisation, death from cardiac causes, MI or stroke did not differ significantly between the two arms—57 aspirin-alone patients (2.4%) and 61 aspirin/clopidogrel patients (2.6%) (HR 0.94; 95% CI 0.66–1.35; P=0.75).
http://circ.ahajournals.org/content/129/3/304.abstract

Primary prophylaxis for venous thromboembolism in people undergoing major amputation of the lower extremity .
This review notes that as only two studies were included, each comparing different interventions, there is insufficient evidence to make any conclusions about the most effective thromboprophylaxis regimen in patients undergoing lower limb amputation.
http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010525.pub2/full

Associations with anticoagulation: a cross-sectional registry-based analysis of stroke survivors with atrial fibrillation.
This cross-sectional analysis (n=3429) found on multivariate analysis, older age (OR 0.97, 95% CI 0.96–0.98) and higher deprivation scores (OR 0.59, 0.57–0.76) were independently associated with non-prescription of vitamin K antagonists.
http://heart.bmj.com/content/early/2014/01/23/heartjnl-2013-305267.abstract

 

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

 

 

The findings of the King's Thrombosis Centre's population pharmacokinetic modelling study of enoxaparin in pregnancy was reviewed by Nature Reviews Cardiology. The review assessed the significance of the findings and includes a commentary from Professor Jeff Ginsberg from McMaster University, Hamilton, ON, Canada.

Access the article here.

King's Thrombosis Centre have published an article in CIRCULATION describing the development of a robust pharmacokinetic model of enoxaparin in pregnant women. At each monthly clinic visit, participants provided blood samples for assessment of anti-factor Xa activity in plasma at three time points—trough (the lowest concentration before the next dose), and 1 h and 3 h after enoxaparin injection. One hundred and twenty three patients contributed 795 anti-Xa activities for the modelling. Both enoxaparin clearance and volume of distribution were increased during pregnancy and the findings provide evidence for prescribing once daily enoxaparin for the treatment of antenatal VTE. The conclusion is that national and international guideline recommendations for enoxaparin dosing in pregnancy should be re-considered.

 

Access the article here

King's Thrombosis Centre have published an article in CHEST evaluating the impact of compulsory VTE risk assessment on the incidence of hospital-associated VTE. A significant reduction in the incidence of HAT was observed following sustained achievement of 90% risk assessment (RR 0.88, 95% CI 0.74 - 0.98; P=0.014). The article entitled "Comprehensive venous thromboembolism prevention programme incorporating mandatory risk assessment reduces the incidence of hospital-associated thrombosis" can be accessed here

King's Thrombosis Centre have published an article in the British Journal of Haematology evaluating the early predictors of post-thrombotic syndrome. The article entitled "Presenting D-dimer and early symptom severity are independent predictors for post-thrombotic syndrome following a first deep vein thrombosis" can be accessed here.