Items filtered by date: October 2020

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.

 

Data on phase III ROCKET-AF trial of rivaroxaban to be reanalysed after discovery investigators used faulty point of care device (INRatio)

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.

 

What are the risks of using antiplatelet agents in combination with the Novel Oral Anticoagulants (NOACs) in patients with atrial fibrillation, and how should the potential risks be managed?

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

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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.

 

FDA Drug Safety Communication: Review finds long-term treatment with clopidogrel does not change risk of death

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

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Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

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.

 

Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial

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

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Effect of Warfarin Treatment on Survival of Patients with Pulmonary Arterial Hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL)

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.

 

Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial

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.

 

Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack

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

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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.

 

Impact of proton pump inhibitor treatment on gastrointestinal bleeding associated with non-steroidal anti-inflammatory drug use among post-myocardial infarction patients taking antithrombotics: nationwide study

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).

 

FDA approves idarucizumab (Praxbind), the first reversal agent for the anticoagulant dabigatran (Pradaxa)

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.

 

Acute coronary syndromes

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 FDA approves first Factor X concentrate (Coagadex®) to treat patients with hereditary Factor X (10) deficiency

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.

 

Left Atrial Appendage Occlusion Device and Novel Oral Anticoagulants Versus Warfarin for Stroke Prevention in Nonvalvular Atrial Fibrillation: Systematic Review and Meta-Analysis of Randomized Controlled Trials

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

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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

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Efficacy and safety of ticagrelor for long-term secondary prevention of atherothrombotic events in relation to renal function: insights from the PEGASUS-TIMI 54 trial

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

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The Clots in Legs Or sTockings after Stroke (CLOTS) 3 trial: a randomised controlled trial to determine whether or not intermittent pneumatic compression reduces the risk of post-stroke deep vein thrombosis and to estimate its cost-effectiveness

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).

 

Evaluation of Patients With Suspected Acute Pulmonary Embolism: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians

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.

 

Sulodexide for the Prevention of Recurrent Venous Thromboembolism: The SURVET Study: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial

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.

 

Bivalirudin versus unfractionated heparin: a meta-analysis of patients receiving percutaneous coronary intervention for acute coronary syndromes

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

 

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European CHMP recommends granting of marketing authorisation for idarucizuma (Praxbind) as antidote to dabigatran

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.

 

Edoxaban for preventing stroke and systemic embolism in people with non valvular atrial fibrillation – guidance (TA355)

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

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An Observational Study of the Factor Xa Inhibitors Rivaroxaban and Apixaban as Reported to Eight Poison Centers, Editor’s Capsule Summary

Annals of Emergency Medicine

Study (n=243) found bleeding after ingestion of Xa inhibitor is uncommon. Prothrombin time, APTT, or INR may be elevated in minority of cases but appears unreliable to measure bleeding risk. Massive acute ingestion in suicides may result in significant anticoagulation.

 

Incidence of cardiovascular events and gastrointestinal bleeding in patients receiving clopidogrel with and without proton pump inhibitors: an updated meta-analysis

Open Heart

Meta-analysis of 39 studies suggests that the controversial interaction between PPIs and clopidogrel seen in in-vitro studies has no clinical significance. Rather, patients on PPIs have higher burden of comorbidities and thus most likely have increased risk for adverse CV events.

 

FDA approves recombinant Factor VIII (Nuwiq®) for the treatment of Haemophilia A

Biospace Inc.

The FDA has approved Nuwiq® for the treatment of adults and children with Haemophilia A. This is the first B-domain deleted recombinant Factor VIII derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of this population.

 

Combined oral contraceptives: the risk of myocardial infarction and ischemic stroke

Cochrane Database of Systematic Reviews

Risk was only increased in women using COCs containing ≥ 50 µg of estrogen. When combined with results of studies on risk of venous thrombosis in COC users, it seems that the COC pill containing levonorgestrel and 30 µg of estrogen is safest oral form of hormonal contraception.

 

 

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