Items filtered by date: October 2020

Association of Ticagrelor vs Clopidogrel With Net Adverse Clinical Events in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Journal of the American Medical Association
Study (n=31,290 propensity matched pairs) reports the 1-yr risk of net adverse clinical events was not significantly different between ticagrelor and clopidogrel (15.1% [3484/23 116 person-years] vs 14.6% [3290/22 587 person-years]; hazard ratio, 1.05 [95% CI, 1.00-1.10]; p=.06).


Revised SPC: Alprolix (eftrenonacog alfa) powder and solvent for solution for injection

electronic Medicines compendium
Factor IX inhibition, hypersensitivity and Injection site erythema have been added as common adverse events.


Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial

Journal of the American Medical Association
In 596 critically ill patients, anticoagulation with regional citrate, increased filter life span vs systemic heparin anticoagulation (47 vs 27 hours) but the trial was underpowered to reach conclusions regarding mortality (90-day mortality 51.2% vs 53.6%).


Fibrosis, atrial fibrillation and stroke: clinical updates and emerging mechanistic models

Review outlines the clinical knowledge in this setting, alongside computational modelling frameworks which may provide a mechanistic understanding of the clinical problem of thromboembolisation.


Risk of post-thrombotic syndrome after deep vein thrombosis treated with rivaroxaban versus vitamin-K antagonists: A systematic review and meta-analysis

Thrombosis Research
Review (7 studies; n=2364) found that in comparison to vitamin-K antagonists, rivaroxaban has potential to reduce post-thrombotic syndrome events [OR 0.53, 95% CI: 0.43–0.65, p<0.00001], but well-designed studies with larger sample sizes are needed to corroborate these findings.


Clinical and budget impacts of changes in oral anticoagulation prescribing for atrial fibrillation

English study found that despite nearly one million additional DOAC prescriptions and substantial associated spending in the latter part of this study, the decline in AF-related stroke (fell by 11.3%) led to incremental savings (£289 per-patient) at the national level.


Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial

The Lancet Neurology
Study (n=100) does not provide evidence that tranexamic acid prevents intracerebral haemorrhage growth (occurred in 26 [52%] placebo vs. 22 [44%] tranexamic acid group; OR 0·72;95% CI 0·32–1·59, p=0.41), although treatment was safe with no increase in thromboembolic complications.


Anticoagulation in atrial fibrillation

Review notes 1 in 3 people will be diagnosed with AF at some point in their lives; over 1.2m individuals in UK have been diagnosed with AF; thousands still remain undiagnosed, and risk of AF-related stroke can be mitigated through anticoagulation, with a 66% risk reduction.




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:

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Rituximab for treating inhibitors in people with inherited severe haemophilia

Cochrane Database of Systematic Reviews
This review did not identify any relevant randomised controlled trials. The research evidence available was limited to case reports and case series therefore no conclusions could be drawn on the efficacy and safety of rituximab for treating inhibitors in people with haemophilia.


Topline Phase III data of avatrombopag for treatment of chemotherapy-induced thrombocytopenia

Biospace Inc.
Though avatrombopag increased platelet counts relative to placebo, the study did not meet the composite primary endpoint of avoiding platelet transfusions, chemotherapy dose reductions by 15% or greater, and chemotherapy dose delays by four days or more.


Cessation of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation

In 'real world' cohort (n=1415), persistence of DOAC use was found to be high with only 8.8 cessations/100 patient-years follow-up and rate of serious adverse events rate was low at 1.6/100 patient-years; most common cause of cessation of index DOAC (53.1%) was patient choice.


Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial

JAMA Neurology
Analysis (n=3699) found those with cerebral microbleeds had higher rates of recurrent stroke, ischaemic stroke, intracerebral haemorrhage, and mortality during 11 months of follow-up, but this did not appear to influence the effects of rivaroxaban (15mg) on clinical outcomes.


Lifelong Aspirin for All in the Secondary Prevention of Chronic Coronary Syndrome: Still Sacrosanct or Is Reappraisal Warranted?

This narrative review discusses recent trials that inform the current use of aspirin in the secondary prevention of chronic coronary syndrome (CCS), a new term for stable coronary artery disease defined in the 2019 European Society of Cardiology guidelines.


Revised SPC: Praxbind (idarucizumab) 2.5 g/50 mL solution for injection/infusion

electronic Medicines compendium
Section 5.1 has been updated with information on a paediatric patient (between 16-<18 years old) treated with idarucizumab during an open-label safety trial.


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:

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Warfarin and other anticoagulants – monitoring of patients during the COVID-19 pandemic

Medicines and Healthcare products Regulatory Agency
MHRA has published guidance following concerns over an apparent increase in the number of patients taking warfarin found to have elevated INR values during the pandemic; and reminds healthcare professionals and patients that continued close INR monitoring is crucial.


Stroke Thrombolysis With Tenecteplase to Reduce Emergency Department Spread of Coronavirus Disease 2019 and Shortages of Alteplase

JAMA Neurology
Viewpoint from US perspective notes the situation of an acute stroke emergency is a particularly vulnerable situation for exposure and transmission of COVID-19; it advocates for expanded usage of tenecteplase as means of avoiding spread and easing potential shortages of alteplase.


Effect of Pre-Hospital Crushed Prasugrel Tablets in Patients with STEMI Planned for Primary Percutaneous Coronary Intervention: The Randomized COMPARE CRUSH Trial

RCT (n=727) found pre-hospital administration of loading dose of crushed prasugrel tablets does not improve TIMI 3 flow in infarct-related artery pre-PCI or complete ST-segment resolution 1h post-PCI vs. intact tablets, and there were no differences in ischaemic events at 30 days.


A perfect storm: Root cause analysis of supra-therapeutic anticoagulation with vitamin K antagonists during the COVID-19 pandemic

Thrombosis Research
Study of INR results show significant increase in high INRs during COVID-19 pandemic, with majority occurring after introduction of lockdown, with 30/3214 (0.9%) INR samples >8.0 (n=30) vs. 6/4079 (0.1%; n=6) during same period in previous year (OR 6.3, 95% CI, 2.6–15.2; p<0.001).


Warfarin in patients with mechanical heart valves

British Medical Journal
Practice article highlights these patients require lifelong anticoagulation with warfarin to prevent thromboembolism, low dose aspirin can be added in patients with higher risk of thromboembolic events, and DOACs are not currently recommended as safety has not been established.


Investigation into management of venous thromboembolism risk in patients following thrombolysis for an acute stroke

Healthcare Safety Investigation Branch
Follow review of a case of a 78-year old woman who suffered a pulmonary embolism whilst recovering from a stroke in hospital, this report makes a safety recommendation for a stroke specific venous thromboembolism assessment tool.



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:



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Multiple versus fewer antiplatelet agents for preventing early recurrence after ischaemic stroke or transient ischaemic attack

Cochrane Database of Systematic Reviews
This review (15 RCTs; n=17,091) concludes multiple antiplatelet drugs reduced risk of stroke recurrence (5.78% v 7.84%, RR 0.73, 95% CI 0.66-0.82; P<0.001) but increased risk of bleeding (e.g. extracranial haemorrhage 6.38% vs 2.81%, RR 2.25, 95% CI 1.88-2.70; P<0.001).


American Society of Hematology publishes draft guidelines on the use of anticoagulation in patients with COVID-19 for review

American Society of Hematology
The DRAFT guidelines, agreed by an international panel, suggest using prophylactic-intensity over intermediate-intensity or therapeutic-intensity anticoagulation in patients with COVID-19 related critical illness or acute illness who do not have suspected or confirmed VTE.


Antiphospholipid Antibodies in Critically Ill Patients With COVID‐19

Arthritis & Rheumatology

Study (n=66) found antiphospholipid antibodies (APSA) were common (47%) in patients in critical condition (CC) but were not present among those not in CC. APSA may be transient & disappear in few weeks, but in genetically predisposed, may trigger condition similar to APS syndrome.

Interventions commonly available during pandemics for heavy menstrual bleeding: an overview of Cochrane Reviews

Cochrane Database of Systematic Reviews
Review (44 RCTs, n=3196) found moderate‐certainty evidence that shows antifibrinolytics & combined hormonal contraceptives reduce heavy menstrual bleeding vs. placebo; and low‐certainty evidence that antifibrinolytics are more effective vs. NSAIDs/short‐cycle progestogens.


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:

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Dabigatran trough concentrations in very elderly patients

European Journal of Hospital Pharmacy
Observational study of 75 patients with atrial fibrillation, found trough concentrations were considerably higher in the highest age category. Dose-normalised medians were 0.66, 0.83 and 1.20 ng/mL/mg in the <75, 75–84 and ≥85 age groups, respectively (p=0.004).


NIHR Alert: Tranexamic acid should not be used for patients with severe gastrointestinal bleeding

National Institute for Health Research
Expert commentary is provided on the HALT-IT (Haemorrhage alleviation with tranexamic acid-Intestinal system) trial of more than 12,000 patients; which showed tranexamic acid does not improve outcomes but increases side effects for this group of patients compared to placebo.


Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial

JAMA Cardiology
Secondary analysis of RCT (n=4129) found risk of major vascular events was greater than 10% over 30 months for high risk patients and treatment with combination of rivaroxaban and aspirin vs aspirin alone resulted in estimated 4.2% absolute risk reduction for major vascular event.



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:

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