Items filtered by date: April 2021

Announcement regarding AstraZeneca vaccine and next steps

NHS England
This letter which follows the updated guidance from the MHRA and the independent Joint Committee on Vaccination and Immunisation, sets out the criteria for administration of the Astra Zeneca vaccine following reports of concurrent thrombosis and thrombocytopenia.

 

Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination

New England Journal of Medicine
Article reports 5 Norwegian cases (age 32 to 54 years) of severe venous thrombosis and thrombocytopenia 7 to 10 days after first vaccine dose, all whom had high level of antibodies to platelet factor 4–polyanion complexes, but no previous exposure to heparin.

 

Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination

New England Journal of Medicine
Report describes 11 German/Austrian pts (9 women; median age 36 years) who developed immune thrombotic thrombocytopenia mediated by platelet-activating antibodies against PF4, which clinically mimics autoimmune heparin-induced thrombocytopenia, 5 to 16 days after vaccination.

 

Screening and management of atrial fibrillation in primary care

British Medical Journal
This review explores the epidemiology, screening, and risk assessment of AF, as well as management of its symptoms (rate and various rhythm control options) and stroke risk (anticoagulation and other treatments), and offers a model for integration of components of AF care.

 

Biomarker-based risk prediction with the ABC-AF scores in patients with atrial fibrillation not receiving oral anticoagulation

Circulation
Data from 2 trials(n=4305) found the ABC-AF scores showed better discrimination vs traditional risk scores & were recalibrated for precise risk estimation in patients not on anticoagulants & could provide improved decision support regarding treatment of individual patient with AF.

 

Guided versus standard antiplatelet therapy in patients undergoing percutaneous coronary intervention: a systematic review and meta-analysis

The Lancet
Review (11 RCTs, 3 observational) found guided selection of antiplatelets was associated with a reduction in major adverse cardiovascular events (RR 0.78, 95% CI 0.63–0.95, p=0.015) and other individual outcomes vs standard therapy; outcomes varied according to strategy used.

 

Adverse Events Associated With the Addition of Aspirin to Direct Oral Anticoagulant Therapy Without a Clear Indication

JAMA Internal Medicine
Cohort study (n=3280 at 4 anticoag clinics in Michigan) found ~one-third of patients with AF and/or VTE on a DOAC received aspirin without clear indication, and concurrent use was linked to increased bleeding vs. DOAC monotherapy (6.0 vs. 31.6 bleeds/100 patient years, p= 0.01).

 

microINR for anticoagulation therapy (MIB257)

National Institute for Health and Care Excellence
Evidence summary is provided for this portable device for self-measurement of INR. Reduced blood sample size is an innovative aspect. Evidence comes from 5 observational comparative studies vs laboratory-based and alternative point-of-care meters.

 

 

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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Andexanet alfa for reversing anticoagulation: Final appraisal document

National Institute for Health and Care Excellence
In DRAFT guidance, NICE recommends andexanet alfa as an option for reversing anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding in the gastrointestinal tract, if the company provides it according to the commercial arrangement.

 

MHRA reports latest Yellow Card reporting data on blood clots in recipients of Covid-19 vaccines

Medicines and Healthcare products Regulatory Agency
As of 24 March, the MHRA received 22 reports of cerebral venous sinus thrombosis and 8 reports of other thrombosis events with low platelets, out of a total of 18.1 million doses of COVID-19 Vaccine AstraZeneca. The benefits of Covid-19 vaccines continue to outweigh any risks.

 

Perioperative Neurological Evaluation and Management to Lower the Risk of Acute Stroke in Patients Undergoing Noncardiac, Nonneurological Surgery: A Scientific Statement From the American Heart Association/American Stroke Association

Circulation
This scientific statement summarises established risk factors for perioperative stroke, preoperative & intraoperative strategies to mitigate risk of stroke, suggestions for postop assessments, & treatment approaches for minimising permanent neurological dysfunction in this group.

 

Management of antithrombotic therapy in patients undergoing transcatheter aortic valve implantation: a consensus document of the ESC Working Group on Thrombosis and the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in collaboration with the ESC Council on Valvular Heart Disease

European Heart Journal
Recommendations of latest 2017 ESC/EACTS guidelines are mostly based on expert opinion. This viewpoint provides updated therapeutic insights on antithrombotic treatment during and after transcatheter aortic valve implantation, based on recent studies and RCTs.

 

JCVI statement on use of the AstraZeneca COVID-19 vaccine: 7 April 2021

Joint Committee on Vaccination and Immunisation
JCVI has advised that it is preferable for adults aged <30 years without underlying health conditions that put them at higher risk of severe COVID-19 disease, to be offered an alternative COVID-19 vaccine, if available.

 

 

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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Relative risk of arterial and venous thromboembolism in persons with cancer vs. persons without cancer—a nationwide analysis

European Heart Journal
Austrian analysis (2006–07; n = 8,306,244) found strong association between cancer and arterial thromboembolism (RR 6.88; 95% CI 4.81–9.84) and venous thromboembolism (14.91; 8.90–24.95) and support concept of shared risk factors and pathobiology between these diseases.

 

Effectiveness and Safety of Direct Oral Anticoagulants Versus Warfarin in Patients With Valvular Atrial Fibrillation: A Population-Based Cohort Study

Annals of Internal Medicine
In this retrospective American study (n= 56,336), patients with valvular AF who were new users of DOACs had lower risks for ischaemic stroke or systemic embolism (HR 0.64 [95%CI, 0.59-0.70]) and major bleeding events (HR 0.67 [CI 0.63-0.72]) vs new users of warfarin.

 

Thromboembolism and the Oxford–AstraZeneca COVID-19 vaccine: side-effect or coincidence?

The Lancet
Danish registry study (n=4, 915 ,426, 9 years of data) suggests that the reported number of thromboembolic events with the AZ vaccine does not seem to be increased vs incidence rates from the entire Danish population before the introduction of the vaccination programme.

 

AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues

European Medicines Agency
EMA's safety committee has met to discuss ongoing review of very rare cases of unusual blood clots linked to low numbers of platelets, in people vaccinated with AZ's COVID-19 vaccine (now called Vaxzevria). At present, no specific risk factors or causal link have been identified.

 

 

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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