Periprocedural Stroke and Bleeding Complications in Patients undergoing Catheter Ablation of Atrial Fibrillation with Different Anticoagulation Management: Results from the "COMPARE" Randomized Trial

Circulation
This open-label study (n=1584) found that performing catheter ablation for AF without stopping warfarin reduced the incidence of thromboembolic events 48 hours post-ablation, when compared to stopping warfarin and bridging with LMWH (0.25% v 4.9%, respectively; p<0.001).

 

Door-to-Needle Times for Tissue Plasminogen Activator Administration and Clinical Outcomes in Acute Ischemic Stroke Before and After a Quality Improvement Initiative

Journal of the American Medical Association
This US study found implementation of a national quality improvement initiative for acute ischaemic stroke improved door-to-needle times for tPA administration; this was associated with lower in-hospital mortality (9.93% v 8.25%) and ICH (5.68% v 4.68%; both P<0.001).

 

Effect of the Use of Ambulance-Based Thrombolysis on Time to Thrombolysis in Acute Ischemic Stroke: A Randomized Clinical Trial

Journal of the American Medical Association
Use of a specialised ambulance in which patients could have thrombolysis administered before transport to hospital where appropriate decreased time to treatment by 25 min, with no increase in adverse events. Further studies are needed to assess effects on clinical outcomes.

 

Thrombocytosis is associated with increased short and long term mortality after exacerbation of chronic obstructive pulmonary disease: a role for antiplatelet therapy?

Thorax
Thrombocytosis was associated with 1-year mortality (OR 1.53 (95% CI 1.03 to 2.29, p=0.030) but treatment with an antiplatelet drug (aspirin or clopidogrel) reduced this mortality rate (OR 0.63 (95% CI 0.47 to 0.85, p=0.003) in 1343 patients with acute exacerbations of COPD.

 

Expert position paper on the management of antiplatelet therapy in patients undergoing coronary artery bypass graft surgery

European Heart Journal
This review specifically addresses; risk stratification for bleeding and recurrent ischaemic events, temporary interruption of antiplatelet therapy, bridging strategies, use of platelet function monitoring, and blood sparing management strategies.

 

 

 

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 Taking an Oral Anticoagulant: A Nationwide Cohort Study

Circulation
This study in 8700 AF pts with stable CHD found addition of antiplatelet to vitamin K antagonist not linked to reduced risk of recurrent coronary events/thromboembolism, whereas bleeding risk increased significantly: HR aspirin 1.50; 95% CI, 1.23–1.82; clopidogrel 1.84; 1.11–3.06

 

Venous thromboembolic diseases: Evidence Update April 2014

National Institute for Health and Care Excellence 
A summary of selected new evidence published since the NICE guidance on venous thromboembolic diseases (CG 144; 2012) notes that rivaroxaban, apixaban, dabigatran and edoxaban have since been approved and have been or are currently being reviewed by NICE.

 

Bleeding Risk of Patients With Acute Venous Thromboembolism Taking Nonsteroidal Anti-Inflammatory Drugs or Aspirin

JAMA Internal Medicine
This analysis of observational data from the EINSTEIN clinical trials (n=8246) found that use of aspirin or NSAIDs concomitantly with anticoagulation increased the risk of clinically relevant or major bleeding in patients with venous thromboembolism.

 

Anticoagulation in atrial fibrillation

British Medical Journal
This review discusses the rationale for anticoagulation in patients with atrial fibrillation; risk stratification for treatment; available agents; the appropriate implementation of these agents; and additional, specific clinical considerations for treatment.

 

Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism

New England Journal of Medicine
This study (n=1,006) of normotensive patients with intermediate-risk PE found that use of tenecteplase reduced the risk of death or haemodynamic decompensation (2.6% v 5.6% heparin alone) but increased the risk of major bleeding (11.5% v 2.4%) and stroke (2.4% v 0.2%).

 

 

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

 

Low-Dose Aspirin for Prevention of Morbidity and Mortality From Preeclampsia: A Systematic Evidence Review for the U.S. Preventive Services Task Force

Annals of Internal Medicine

This review found low-dose aspirin was associated with absolute risk reductions of 2-5% for preeclampsia (RR 0.76; 95% CI 0.62 to 0.95), 1-5% for intrauterine growth restriction (0.80; 0.65 to 0.99), and 2-4% for preterm birth (0.86; 0.76 to 0.98), depending on baseline risk.

 

Direct thrombin inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in people with non-valvular atrial fibrillation

Cochrane Database of Systematic Reviews
DTIs found to be as efficacious as VKAs for composite outcome of vascular death and ischaemic events; only dabigatran dose 150mg BD found superior to warfarin. DTIs linked to fewer major haemorrhagic events. ADRs leading to treatment discontinuation occurred more often with DTIs.

 

FDA approves dabigatran (Pradaxa®) for treatment and reduction in the risk of recurrent deep vein thrombosis and pulmonary embolism

Biospace Inc.
The US FDA has approved dabigatran etexilate mesylate (Pradaxa®) for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

 

Low molecular weight heparin for prevention of central venous catheterization-related thrombosis in children

Cochrane Database of Systematic Reviews
A single study reported imprecise effects for the risk of CVC-related thrombosis in children on a CVC anticoagulant prophylaxis regimen. The quality of the evidence was low due to the fact that the included study was clearly underpowered, hampering any conclusions.

 

Balancing stroke and bleeding risks in patients with atrial fibrillation and renal failure: the Swedish Atrial Fibrillation Cohort study

European Heart Journal
This Swedish registry based study (n=307,351) concluded that patients with both AF and renal failure will benefit most from having the same treatment as recommended for other patients with AF, without setting a higher or lower threshold for treatment.

 

New SPCs: Voncento (factor VIII, von willebrand factor) 500 IU / 1200 IU and 1000 IU / 2400 IU powder and solvent for solution for injection/infusion

electronic Medicines Compendium
Two SPCs are now available for a new product - Voncento® (factor VIII, von willebrand factor).

 

Point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor): diagnostics consultation

National Institute for Health and Care Excellence
DRAFT NICE guidance recommends the CoaguChek XS system for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have AF or heart valve disease if certain caveats are met. The INRatio2 PT/INR monitor is only recommended for use in research.

 

 

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

 

Recent Advances in Antidotes for Direct Oral Anticoagulants: Their Arrival Is Imminent

Canadian Journal of Cardiology

Several antidotes for direct oral anticoagulants are being developed and recently presented data have raised hopes that their introduction into clinical practice is imminent. In this article, the authors review the latest advances in their development.

 

FDA approves first long-acting recombinant coagulation Factor IX concentrate (Alprolix) for patients with haemophilia B

Biospace Inc.

This has been approved in US for control and prevention of bleeding episodes, perioperative management and routine prophylaxis, in patients with haemophilia B. It was developed using Fc fusion and thus has a more prolonged circulation in body which extends time between infusions.

 

Lack of Concordance between Empirical Scores and Physician Assessments of Stroke and Bleeding Risk in Atrial Fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry

Circulation

This analysis of 10,094 AF patients found little agreement between provider-assessed risk and empirical stroke and bleeding risk scores in AF. These differences may partly explain current divergence of anticoagulation treatment decisions from guideline recommendations.

 

2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation

Circulation

These US guidelines for management of atrial fibrillation cover: • Pathophysiology • Clinical evaluation: • Prevention of thromboembolism • Rate control • Rhythm control • Specific patient groups • Evidence gaps and future research directions

 

Combined oral contraceptives: venous thrombosis

Cochrane Database of Systematic Reviews

All COCs investigated in this analysis were linked to increased risk of VTE. The effect size depended both on progestogen used and dose of ethinylestradiol (EE). Thus COCs with lowest possible dose of EE and good compliance should be prescribed, i.e. 30 μg EE with levonorgestrel.

 

Preconception low-dose aspirin and pregnancy outcomes: results from the EAGeR randomised trial

The Lancet

In women with 1 or 2 losses, there was no difference in live birth rate (309/535 for aspirin vs 286/543 for placebo; p=0•0984). However, in women with 1 loss at less than 20 weeks gestation, there was a significant difference (151/242 for aspirin vs 133/250 for placebo; p=0•0446)

 

Vibropulse for cellulitis or venous leg ulcers

Midlands Medicines

This is an evidence based summary of Vibropulse™, a device that utilises cycloidal vibration therapy and is prescribable on an FP10 for cellulitis or venous leg ulcers. The review concludes that there are currently insufficient data in this area to recommend its use.

 

 

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

 

 

 

 

 

 

 

Five-Year Survival in Patients with ST-Segment Elevation Myocardial Infarction According to Modalities of Reperfusion Therapy: The French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Cohort

 

Circulation

 

This analysis of registry data reports 5-year survival following STEMI of 88% for patients receiving fibrinolysis, 83% for PCI and 59% for no reperfusion. The authors suggest a pharmaco-invasive strategy constitutes a valid alternative to PCI on a nationwide scale.

 

 

Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial

 

European Heart Journal

 

This analysis of data from 779 pts experiencing major bleeding during ROCKET AF found administration of fresh frozen plasma and prothrombin complex concentrates was less frequent in the rivaroxaban arm. Use of transfused packed RBC and outcomes were however similar 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

 

Factor Xa Inhibitors vs Warfarin for Preventing Stroke and Thromboembolism in Patients With Atrial Fibrillation

Journal of the American Medical Association

Based on a Cochrane review, this JAMA Clinical Evidence Synopsis concludes that compared with warfarin, factor Xa inhibitors are associated with a lower risk of stroke and systemic embolic events and fewer rates of intracranial haemorrhage and mortality in patients with AF.

 

Subdural haematoma in the elderly

British Medical Journal

This article on subdural haematoma is one of a series highlighting conditions that may be more common than many doctors realise or may be missed at first presentation. It covers how common it is, why it is missed and why this matters, and its diagnosis and management.

 

The young patient with asymptomatic atrial fibrillation: what is the evidence to leave the arrhythmia untreated?

European Heart Journal

This review summarises epidemiological data on young AF, efficacy, and limitations of rate and rhythm control in young patients, information on arrhythmia progression and outcome, and the consequences of these data for AF treatment in young, asymptomatic 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

 

Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type

European Heart Journal

This 3-yr study (n=8709 on zotarolimus-eluting stent [ES]/sirolimus-ES) suggests dual antiplatelet therapy (DAPT) use influenced rate of stent thrombosis to a different extent, depending upon type of implanted DES; and optimal duration of DAPT will likely depend upon stent type.

 

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

 

Describing deprescribing

Drug and Therapeutics Bulletin

This article discusses increasing multimorbidity and polypharmacy amongst the population and the risks associated with these factors. The article highlights that stopping prescribing or "deprescribing" is an important consideration in the medicines optimisation process.

 

Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial

The Lancet

Elastic compression stockings (ECS) did not prevent post-thrombotic syndrome after 1st proximal DVT [incidence of PTS=14.2% in active ECS vs 12.7% in placebo (adjusted HR 1.13, 95% CI 0.73-1.76; p=0.58)]. The authors state the findings do not support routine ECS use post DVT.

 

Warfarin, Kidney Dysfunction, and Outcomes Following Acute Myocardial Infarction in Patients With Atrial Fibrillation

Journal of the American Medical Association

This cohort study (n=24,317) found that warfarin (vs. none) was linked to lower 1-year risk for composite of death, MI, and ischaemic stroke without higher risk of bleeding in consecutive acute MI patients with AF. This association was not related to severity of concurrent CKD.

 

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

 

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