Items filtered by date: September 2018

Continuation versus discontinuation of antiplatelet therapy for bleeding and ischaemic events in adults undergoing non‐cardiac surgery

Cochrane Database of Systematic Reviews

Review of 5 RCTs (n=666) found low‐certainty evidence that either continuation or discontinuation of antiplatelet therapy before non‐cardiac surgery may make little or no difference to mortality, bleeding requiring surgical intervention, or ischaemic events.

 

Healthcare professional letter: Actilyse (Alteplase) in Acute lschaemic Stroke: Important information on extension to use in adolescents and request for data collection

Boehringer Ingelheim

Following the recent license extension of Actilyse® (alteplase) to include adolescents of 16-17 years in the acute ischaemic stroke indication, Boehringer Ingelheim is requesting collection of further data on safety and efficacy in this population.

 

A systematic review of clinicians' views and experiences of direct‐acting oral anticoagulants in the management of nonvalvular atrial fibrillation

British Journal of Clinical Pharmacology

Review of 10 studies notes in studies reporting clinician preference, DOACs were 1st choice over warfarin in naïve patients based on perceptions of evidence of effectiveness equivalent/superior to warfarin and superior safety. There were concerns about managing over-anticoagulation.

 

Effect of Variation in Published Stroke Rates on the Net Clinical Benefit of Anticoagulation for Atrial Fibrillation

Annals of Internal Medicine

Markov model decision analysis (n=33,434) with warfarin as base case, and DOACs modeled in secondary analysis found variation in published AF stroke rates for patients not on anticoagulants results in multifold variation in net clinical benefit of anticoagulation.

 

An Open-Label Randomized Trial Comparing Oral Anticoagulation with and without Single Antiplatelet Therapy in Patients with Atrial Fibrillation and Stable Coronary Artery Disease Beyond One Year after Coronary Stent Implantation: The OAC-ALONE Study

Circulation

RCT prematurely terminated after enrolling 696 patients in 38 months did not establish non-inferiority of oral anticoagulation (OAC) alone to combined OAC and antiplatelet therapy in patients with AF and stable coronary artery disease beyond 1 year after stenting.

 

Improved Stroke Prevention in Atrial Fibrillation After the Introduction of Non–Vitamin K Antagonist Oral Anticoagulants

Stroke

Analysis of pharmacy claims data found increased oral anticoagulant use (from 51.6% to 73.8%) contributed to marked reduction of ischaemic strokes (2.01/100 person-years in 2012 to 1.17 in 2017; incidence rate ratio, 0.58; 95% CI, 0.52–0.65) without increasing bleeding rates.

 

Non–Vitamin K Antagonist Oral Anticoagulants for Mechanical Heart Valves: Is the Door Still Open?

Circulation

Mechanical valves currently pose absolute contraindication to DOACs based on results of single phase II study (RE-ALIGN). Article calls on several aspects of both preclinical studies and RE-ALIGN to be critically re-evaluated to identify patients most likely to benefit from DOACs.

 

AF screening: who is calling the tune?

Drug and Therapeutics Bulletin

Editorial highlights need to recognise gaps in evidence for population screening (PS), uncertainty over harm:benefit ratio of anticoagulation in people at lower risk, impact of labelling people with AF diagnosis, and guard against industry-led incremental drift to widespread PS.

 

Vorapaxar for HIV-associated inflammation and coagulopathy (ADVICE): a randomised, double-blind, placebo-controlled trial

The Lancet

This RCT (n=65) demonstrated that vorapaxar, a licensed inhibitor of proteinase activated receptor-1, had no effect on D-dimer concentrations in HIV-infected patients receiving stable antiretroviral therapy but at risk of poor outcomes.

 

Antifibrinolytic therapy for preventing oral bleeding in people on anticoagulants undergoing minor oral surgery or dental extractions

Cochrane Database of Systematic Reviews

There were no eligible trials in people on continuous DOAC treatment. For vitamin K antagonists (4 studies; n=253) there seems to be a beneficial effect of locally applied tranexamic acid; however definitive conclusions cannot be made due to limitations of the 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

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Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia

Gastroenterology

The ADAPT-1 and ADAPT-2 RCTs reported superiority of avatrombopag vs placebo in reducing need for platelet transfusions or rescue procedures for bleeding in patients with thrombocytopenia and chronic liver disease undergoing a scheduled procedure.

 

Anticoagulation for the long‐term treatment of venous thromboembolism in people with cancer

Cochrane Database of Systematic Reviews

Review of 16 RCTs (n= 5167) found evidence showing that low molecular weight heparins (LMWHs) vs. vitamin K antagonists probably produces an important reduction in venous thromboembolism (VTE); and DOACs vs. LMWH, may likely reduce VTE but may increase risk of major bleeding.

 

Long-Term Risk of Venous Thromboembolism in Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study

Journal of Clinical Oncology

Study reports childhood cancer survivors are at increased risk for VTE across their lifespan and a diagnosis of VTE increases mortality risk. Late VTE incidence among survivors and siblings was 1.1 and 0.5 events /1000 person-years, respectively (RR, 2.2; 95% CI, 1.7 to 2.8).

 

Effect of Aspirin on All-Cause Mortality in the Healthy Elderly

New England Journal of Medicine

RCT (n=19,114) found an increased risk of death from any cause for aspirin vs placebo (12.7 vs 11.1 events/1000 person-years, HR 1.14, 95% CI 1.01-1.29). Cancer was the major contributor to higher mortality with aspirin accounting for 1.6 excess deaths/1000 person-years.

 

Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly

New England Journal of Medicine

RCT (n=19,114) found no difference in rate of cardiovascular disease for aspirin vs placebo (10.7 vs 11.3 events/1000 person-years, HR 0.95, 95% CI 0.83-1.08). Major haemorrhage was more common with aspirin (8.6 vs 6.2 events/1000 person years, 1.38, 1.18-1.62).

 

Effect of Aspirin on Disability-free Survival in the Healthy Elderly

New England Journal of Medicine

RCT (n=19,114) found no difference in the composite rate of death, dementia and persistent physical disability for aspirin vs placebo (21.5 vs 21.2 events/1000 person-years, HR 1.01, 95% CI 0.92-1.11). Major haemorrhage was more common with aspirin (3.8% vs 2.8%, 1.38, 1.18-1.62).

 

Coagulation Test Interpretation in a Patient Taking Direct Oral Anticoagulant Therapy

Journal of the American Medical Association

This short review, in the form of a case vignette, highlights that DOAC-specific coagulation tests such as anti-Xa assay and dilute thrombin time may help guide clinical decisions in bleeding patients or in those requiring urgent surgery. Time of last dose needs to be considered.

 

Prothrombin Complex Concentrates for Perioperative Vitamin K Antagonist and Non–vitamin K Anticoagulant Reversal

Anesthesiology

Review found concentrate was consistently shown to reduce INR rapidly and control bleeding effectively. In studies vs. plasma, it was linked to more patients achieving target INRs rapidly, with improved haemostasis, and no differences in thromboembolic event rates were seen.

 

Antithrombotic treatment is associated with intraplaque haemorrhage in the atherosclerotic carotid artery: a cross-sectional analysis of The Rotterdam Study

European Heart Journal

In a large population-based sample of individuals with subclinical carotid atherosclerosis, current and past use of antithrombotics was linked to intraplaque haemorrhage (IPH) in carotid artery plaques. Longer duration of use and higher doses were linked higher frequency of IPH.

 

Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial

The Lancet

RCT (n=12,546; EC aspirin 100mg/d vs. placebo) found event rate was much lower than expected, making study more representative of a low-risk population, and role of aspirin in primary prevention could therefore not be addressed in patients at moderate risk of CVD.

 

European CHMP recommends granting of marketing authorisation for damoctocog alfa pegol (Jivi) for treatment of haemophilia A (congenital factor VIII deficiency)

European Medicines Agency

Damoctocog is a recombinant human factor VIII which replaces the missing coagulation factor VIII needed for effective haemostasis. It will be available as powder and solvent for solution for injection (250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU).

 

 

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

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Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation

Heart

Biomarker substudy (n=4850) suggests in situation without acute increased coagulation activity (e.g AF), apixaban reduces coagulation markers D-dimer and fragment 1+2  to lower degree vs. warfarin, which seems enough to protect against stroke without increasing bleeding risk.

 

Aspirin-Exacerbated Respiratory Disease

New England Journal of Medicine

Review covers atopic diseases, COX-1 inhibitor reactions, medical history, prevalence, non-aspirin-exacerbated respiratory disease, NSAID hypersensitivity, pathological and pharmacopathological features, medical/surgical treatment, aspirin (AS) desensitisation and AS treatment.

 

Anticoagulation for people with cancer and central venous catheters

Cochrane Database of Systematic Reviews

This review (13 RCTs; n=3420) found moderate-certainty evidence that LMWH reduces catheter‐related venous thromboembolism (CR-VTE); evidence was inconclusive for LMWH effects on mortality and effects of vitamin K antagonists (VKA) on mortality or CR-VTE, and for LMWH versus VKA.

 

 

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

Published in News

Venous thromboembolism (VTE) risk assessment: Q1 2018/19

NHS Improvement

This reports details the official statistics for venous thromboembolism (VTE) risk assessment in England for providers for quarter 1 2018/19 (April to June 2018).

 

What is the evidence for the use of Low Molecular Weight Heparins for the prophylaxis of travel-related thrombosis?

Specialist Pharmacy Service

Q+A notes none are specifically licensed for this use and good evidence is lacking, however, benefit of anticoagulant prophylaxis may outweigh risks in those at high risk of developing thromboses during a long haul flight; this use has been suggested by several national bodies.

 

Triple versus guideline antiplatelet therapy to prevent recurrence after acute ischaemic stroke or transient ischaemic attack: the TARDIS RCT

National Institute for Health Research

Trial that was stopped early (n=3096) found use of 3 antiplatelets (intensive: aspirin [AS], clopidogrel, [CP], dipyridamole [DP]) is linked to increased bleeding without significant reduction in recurrence of stroke/TIA vs. guideline antiplatelet agents (AS and DP, or CP alone).

 

 

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

Published in News