Items filtered by date: July 2021

Predictors, time course, and outcomes of persistence patterns in oral anticoagulation for non-valvular atrial fibrillation: a Dutch Nationwide Cohort Study

European Heart Journal
Study (n=93 048) found at least 25% of pts were non-persistent with oral anticoagulants (OACs) within 4 years, resulting in increased risk of composite of ischaemic stroke (IS) and IS-related death (HR 1.79, 95% CI 1.49–2.15) and IS (1.58; 1.29–1.93) vs persistence with OACs.

 

Frailty and clinical outcomes of direct oral anticoagulants versus warfarin in older adults with atrial fibrillation: A cohort study

Annals of Internal Medicine
In this analysis of Medicare claims data, only apixaban was consistently associated with lower rates of the composite end point of death, ischaemic stroke, and major bleeding than warfarin across all frailty levels (n=218,738; HR, 0.68 [CI, 0.65 to 0.72].

 

Abelacimab for Prevention of Venous Thromboembolism

New England Journal of Medicine
This trial (n=412) found treatment with abelacimab, a monoclonal antibody that binds to factor XI, was linked to a lower rate of VTE occurrence compared to enoxaparin; 13%, 5% and 4% in the 30mg, 75mg and 150mg abelacimab groups vs 22%, respectively (p<0.001).

 

Antithrombotic therapies in aortic and peripheral arterial diseases in 2021: a consensus document from the ESC working group on aorta and peripheral vascular diseases, the ESC working group on thrombosis, and the ESC working group on cardiovascular pharmacotherapy

European Heart Journal
This consensus document provides guidance on antithrombotic therapy according to arterial disease localisations and clinical presentation and highlights that multidisciplinary team discussions are important in patients with uncertain ischaemic/bleeding balance.

 

Standard prophylactic versus intermediate dose enoxaparin in adults with severe COVID-19: A multi-center, open-label, randomized controlled trial

Journal of Thrombosis and Haemastasis
RCT of 176 hospitalized adults with severe COVID-19, found no difference in all-cause mortality at 30 days for standard prophylactic dose and intermediate dose enoxaparin (21% vs 15%; HR, 0.67; 95% CI 0.33–1.37; P = 0.31), or rates of arterial or venous thrombosis.

 

COVID-19 rapid guideline: vaccine-induced immune thrombocytopenia and thrombosis (VITT)- guidance (NG200)

National Institute for Health and Care Excellence
This guideline was produced to support clinicians to diagnose and manage this newly recognised syndrome for which there is limited evidence available to inform clinical management. Identification and management of VITT is evolving quickly as the case definition becomes clearer.

 

Risk assessment models for venous thromboembolism in hospitalised adult patients: a systematic review

BMJ Open
Analysis of 51 studies (24 unique risk assessment models [RAMs]) found estimates for sensitivity and specificity were highly variable; results suggest RAMs have generally weak predictive accuracy for VTE, with insufficient evidence to recommend the use of any particular model.

 

Comparative table of low molecular weight heparins and fondaparinux

Specialist Pharmacy Service
This comparative table of low molecular weight heparins and fondaparinux has been compiled to aid product selection should there be a need to switch product in the event of a shortage.

 

Tinzaparin sodium (10,000 IU/ml) 3,500 units in 0.35ml and 4,500 units in 0.45ml pre-filled syringes - Supply Disruption

Medicines and Healthcare products Regulatory Agency
These pre-filled syringes will be unavailable between middle of October 2021 and January 2022 (date TBC). All other presentations of tinzaparin remain unaffected by this supply disruption. This alert contains further information and action for providers.

 

 

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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Network Meta-Analysis of Ticagrelor for Stroke Prevention in Patients at High Risk for Cardiovascular or Cerebrovascular Events

Stroke
Review (26 RCTs; n= 124 495) found compared to controls, addition of aspirin to ticagrelor reduced risk of ischemic stroke (RR, 0.80; 95% CI, 0.71–0.89 vs 0.88; 0.77–1.00 for ticagrelor monotherapy; P=0.05) but was associated with increased bleeding risk.

 

Trends in the pharmacological management of atrial fibrillation in UK general practice 2008–2018

Heart
There was increase in patients with AF appropriately prescribed anticoagulants (from 45.3 to 71.1%) following NICE and ESC guidelines, which correlates with improvements in mortality and stroke outcomes. Beta-blockers appear increasingly favoured over digoxin for rate control.

 

Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial

JAMA Neurology
Sub-group analysis (n= 9983) ticagrelor plus aspirin showed similar efficacy and safety vs aspirin alone in patients presenting with moderate acute ischemic stroke and those presenting with less severe ischemic cerebrovascular events.

 

Aspirin versus P2Y12 inhibitors with anticoagulation therapy for atrial fibrillation

Heart
Study (n= 1075 of which ~60% on PPI) found no significant differences in CV and bleeding events in patients with AF and stable CAD taking rivaroxaban with P2Y12 inhibitors or aspirin in chronic phase (efficacy HR: 1.31; 95% CI 0.88 to 1.94; safety HR: 0.79; 95% CI 0.43 to 1.47).

 

Inappropriate anticoagulation of patients with a mechanical heart valve

Medicines and Healthcare products Regulatory Agency
This alert asks GPs and other NHS providers of anticoagulation services to identify patients with a record of a mechanical heart valve and receiving a DOAC, and to urgently review these patients to ensure they are on the most appropriate anticoagulation therapy and monitoring.

 

 

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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FDA approves dabigatran etexilate oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism

US Food and Drug Administration
Approval is for oral pellets to treat children age 3 months to <12 years and for capsules to treat patients age ≥8 years, with VTE after parenteral anticoagulation for ≥5 days, and also for prevention of recurrent clots in those who have completed treatment for their first VTE.

 

Comparison of effectiveness and safety between ticagrelor and clopidogrel in patients with acute coronary syndrome and on dialysis in Taiwan

British Journal of Clinical Pharmacology
Study (n=2185) of dialysis patients with ACS found at 12 months, ticagrelor group had higher risk for major adverse CV event (aHR 1.29; 95% CI 1.16–1.44) and also higher risk of major bleeding event vs clopidogrel group (sHR 1.49; 95% CI 1.34–1.65).

 

Pulmonary embolism in patients with COVID-19: incidence, risk factors, clinical characteristics, and outcome

European Heart Journal
Spanish retrospective study identified 368 PE in 74,814 patients with COVID-19 attending A+E (~ 0.5%), the incidence of which is ~ninefold higher than in the general (non-COVID-19) population. It notes that mortality is higher in COVID-19 than in non-COVID-19 patients with PE.

 

Number needed to treat for net effect of anticoagulation in atrial fibrillation: Real-World vs. Clinical Trial Evidence

British Journal of Clinical Pharmacology
Post-hoc analysis demonstrated potential clinical applicability of the NNT for net benefit approach; the Calculator of Absolute Stroke Risk was used to show that the NNTnet of anticoagulation therapy at 1-year was 34 in a real-world cohort and 46 in a clinical trial population.

 

Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention: A Prespecified Subgroup Analysis of a Randomized Clinical Trial

JAMA Cardiology
Analysis (n=3024) found incidence of primary composite end point (all-cause death, MI or stroke) at 12 months occurred less frequently in prasugrel vs. ticagrelor group (120 [7.1%] vs 162 [9.8%], respectively; HR 1.41; 95% CI, 1.11-1.78; p= 0.005); bleeding events were comparable.

 

XIENCE stent receives FDA approval for use of only one-month dual antiplatelet therapy (DAPT) in (HBR) high bleeding risk patients

Biospace Inc.
Patients who receive stents are typically on DAPT for 6 to 12 months but may cause bleeding in HBR patients. According to Abbott, the XIENCE 28 and XIENCE 904 studies showed that DAPT can be safely discontinued early (as short as 28 days) with no increased risk in adverse events.

 

Cerebral Venous Thrombosis

New England Journal of Medicine
This review covers diagnosis, based on clinical and imaging features, and treatments that have become available since the subject was last reviewed, in light of current interest, due to rare cases associated with certain of the Covid-19 vaccines.

 

DTB select: Aspirin and gastrointestinal bleeding risk in older people

Drug and Therapeutics Bulletin
Summary and context is provided for an analysis of data from the ASPREE study, which found the 5-year risk of a gastrointestinal bleed in older people taking low-dose aspirin (100mg) ranged from 0.40% in those aged 70 years to 5% in those aged 80 years with multiple risk factors.

 

 

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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