Items filtered by date: December 2020

Spontaneous haemorrhage on apixaban masquerading as obstructive cholangitis after heart surgery

European Heart Journal

This case was a 73-year-old with a presentation of obstructive cholangitis, likely secondary to migration of blood into the common bile duct as a complication of apixaban (2.5 mg 2×/day) 16 days post coronary artery bypass grafting.

 

Meta-Analysis of Direct-Acting Oral Anticoagulants Compared With Warfarin in Patients >75 Years of Age

American Journal of Cardiology

Review (5 studies, n=28,135) reports DOACs have superior efficacy compared to warfarin in reducing stroke or systemic embolisation (HR 0.76, 95% CI 0.67 to 0.86, p <0.01). Apixaban appeared to have the best benefit vs risk profile in this population.

 

Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke

New England Journal of Medicine

RCT (n=225) found use of alteplase between 4.5 and 9.0 hours after stroke onset resulted in higher proportion of patients with no/minor neurologic deficits vs placebo (35.4 vs.29.5%;risk ratio, 1.44; 95% CI, 1.01 to 2.06; p=0.04) but more cases of symptomatic cerebral haemorrhage.

 

 

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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Stroke and transient ischaemic attack in over 16s: diagnosis and initial management – guidance (NG128)

National Institute for Health and Care Excellence

This guideline covers interventions in the acute stage of a stroke or transient ischaemic attack (TIA). It offers the best clinical advice on the diagnosis and acute management of stroke and TIA in the 48 hours after onset of symptoms.

 

Outpatient versus inpatient treatment for acute pulmonary embolism

Cochrane Database of Systematic Reviews

Low‐quality evidence (2 RCTs; n= 451) suggests that there is no clear difference between the interventions in overall mortality, bleeding and recurrence of pulmonary embolism.

 

Optimal Timing of P2Y12 Inhibitor Loading in Patients Undergoing PCI: A Meta-Analysis

Thrombosis and Haemostasis

Review of 23 studies (n=60,907) reported that early P2Y12 inhibitor loading (> 2 hours pre-PCI) was associated with better outcomes vs versus late (< 2 hours pre-PCI or post-PCI; RRR; 22% for MACE, 30% for MI, 25% for death; all p<0.001), without an impact on major bleeding.

 

Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial

JAMA Neurology

Secondary analysis of POINT RCT (n= 4881) reported a low risk of major hemorrhages in patients receiving either clopidogrel plus aspirin or aspirin alone (0.9% vs 0.2%; HR, 3.57; P = 0.003; NNH, 159). However, risk was still increased with dual therapy vs aspirin monotherapy.

 

Comparative Risk of Venous Thromboembolism in Rheumatoid Arthritis Patients Receiving Tofacitinib Versus Those Receiving Tumor Necrosis Factor Inhibitors: An Observational Cohort Study

Arthritis & Rheumatology

Review of 2 databases (n=50,865) found that occurrence of venous thromboembolism when initiating treatment with tofacitinib or a TNF inhibitor was infrequent (<1 per 100 person‐years), with no statistically significant difference in risk between the two treatments.

 

Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease

Circulation

This review discusses developments in the roles of platelets and coagulation factors in atherothrombosis and addresses the rationale and clinical evidence for combining antiplatelet and oral anticoagulant therapy in patients with coronary and peripheral artery disease.

 

Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials

The Lancet

Analysis (20 RCTs;n=26,616) found risk of primary outcome was reduced with new-generation drug-eluting vs. bare-metal stents (HR 0.84, 95% CI 0.78–0.90,p<0·001) due to reduced risk of MI (HR 0·79,0·71–0·88;p<0.001) and possible slight but non-significant cardiac mortality benefit.

 

Individual Treatment Effect Estimation of 2 Doses of Dabigatran on Stroke and Major Bleeding in Atrial Fibrillation: Results from the RE-LY Trial

Circulation

Paper describes the derivation and validation of a prediction model for ischaemic stroke/ systemic embolism (SE) and major bleeding in patients with AF from the 3 treatment arms of the RE-LY trial (n=11,955 in derivation cohort, n=6,158 in validation cohort).

 

Atrial fibrillation type and renal dysfunction as important predictors of left atrial thrombus

Heart

In a real-world population of patients with AF, most on oral anticoagulation, left atrial appendage (LAA) thrombus was found in ~6%. Two variables not included in CHA2DS2-VASc score (AF type and renal dysfunction) proved strong, independent predictors of LAA thrombus.

 

Perception of the Risk of Stroke and the Risks and Benefits of Oral Anticoagulation for Stroke Prevention in Patients With Atrial Fibrillation: A Cross-Sectional Study

Mayo Clinic Proceedings

Study of 227 patients with mean CHA2DS2-VASc score 4.3, and HAS-BLED score 2.3, found negligible correlation between patient perceived and estimated risk of stroke (r=0.07; p=0.32), and bleeding (r=0.16; p=0.02). Most patients overestimated their risks of stroke and bleeding.

 

 

 

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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Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial

JAMA Cardiology

Analysis (n=5022) found over median follow-up of 19.6months, fewer patients on rivaroxaban (vs placebo) had thromboembolic event (TE) including sudden/unwitnessed deaths (SWD; 13.1 vs 15.5%; HR 0.83; 95% CI, 0.72-0.96; p=0 .01). When SWD were excluded, results on TEs were similar.

 

Thromboembolism After Shoulder Arthoplasty and Arthroscopy

Journal of the American Academy of Orthopaedic Surgeons

Review notes that symptomatic VTE after shoulder surgery is an apparently rare but serious event; risk is higher after shoulder arthroplasty than arthroscopy. Asymptomatic VTE is more common. Prevention strategies should balance the risks of VTE with the risks of treatment.

 

Prolonged thromboprophylaxis with low molecular weight heparin for abdominal or pelvic surgery

Cochrane Database of Systematic Reviews

Review of 7 RCTs (n=1,728) found that prolonged thromboprophylaxis significantly reduces the risk of VTE vs thromboprophylaxis during hospital admittance only (5.3% vs 13.2%, OR 0.38, 95% CI 0.26-0.54), without increasing bleeding complications or mortality.

 

Optimal Duration of Aspirin Plus Clopidogrel After Ischemic Stroke or Transient Ischemic Attack: A Systematic Review and Meta-Analysis

Stroke

Review of 10 RCTs (n=15,434) comparing aspirin vs clopidogrel (A+C) to aspirin alone found that short term (≤1 month) & intermediate term A+C (≤3 month) reduced the risk of recurrent stroke and major cardiovascular events, but long term A+C was not associated with benefit.

 

Thromboembolic and haemorrhagic events in patients with atrial fibrillation: a prospective cohort study in UK primary and secondary care

British Journal of General Practice

Study (n=4.943) found antiplatelets were linked to a higher risk of stroke or TIA vs vitamin K antagonists (VKAs) (HR 1.51, 95% CI 1.09-2.09) as well as to an increased risk of GI haemorrhage (1.79, 1.01-3.18). The risk was similar for those on direct oral anticoagulants or VKAs.

 

 

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: FibCLOT (human fibrinogen) injection/infusion

electronic Medicines compendium

SPC has now been updated to detail the licence extension for paediatric use.

 

Anticoagulation therapy in heart failure and sinus rhythm: a systematic review and meta-analysis

Heart

Analysis of 5 trials found anticoagulation (AC) reduced rate of non-fatal stroke (RR 0.63, 95% CI, 0.49-0.81, p=0.001) but increased major haemorrhage (1.88; 1.49-2.38, p=0.001). AC did not reduce all-cause mortality, heart failure (re)hospitalisation or non-fatal MI, vs. control.

 

Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation: Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial

JAMA Neurology

RCT (n=7112) found HAVOC score, left atrial diameter (LAD), and premature atrial contraction frequency predicted subsequent clinical AF. Among subgroup with LAD >4.6 cm (9% overall population), risk of ischaemic stroke was lower in rivaroxaban vs. aspirin group (1.7 vs 6.5%/year).

 

Effectively Initiating and Maintaining Anticoagulation in Patients With Atrial Fibrillation: Lessons Learned From Research and Practice

Circulation

With availability of DOACs, authors have seen large increases in anticoagulation (AC) rates, but considerable gaps in guideline adherence remain among high-risk patients. Article shares practical strategies to address common barriers to initiating/maintaining AC in this group.

 

Oral anticoagulation among atrial fibrillation patients with anaemia: an observational cohort study

European Heart Journal

Observational cohort-study of 18,734 anaemic AF patients suggests treatment with oral anticoagulants increased rate of major bleeding and reduced time in therapeutic range with no reduction in risk of stroke/thromboembolism particularly among patients with moderate/severe anaemia.

 

Risk factors for thromboembolic and bleeding events in anticoagulated patients with atrial fibrillation: the prospective, multicentre observational PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF)

BMJ Open

Study of 5310 pts receiving a VKA and 3156 pts receiving a NOAC found that abnormal liver function, prior stroke or TIA, labile INR, therapy with antiplatelet or NSAIDs, heart failure and age ≥75 yrs were independently associated with thromboembolic and major bleeding events.

 

Direct oral anticoagulation and mortality in moderate to high-risk atrial fibrillation

Heart

Retrospective analysis of patients (n=11,314) with non-valvular atrial fibrillation reports DOAC therapy was associated with a significantly lower risk of death compared with no oral anticoagulation: 7.6% vs 11.1% per year respectively (HR=0.69, p<0.001).

 

 

 

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: FEIBA (Factor VIII Inhibitor Bypassing Activity) 500 U powder and solvent for solution for infusion

electronic Medicines compendium

Sections 4.4 and 4.5 now advise isohemagglutinins may interfere with serological tests. Additionally, the SPC advises of increased risk of thrombotic microangiopathy with FEIBA in patients receiving emicizumab prophylaxis.

 

Revised SPC: Revolade (eltrombopag) film-coated tablets – all strengths

electronic Medicines compendium

The SPCs have been updated with information related to liver functions tests, thrombotic and thromboembolic complications and myelodysplastic syndrome.

 

Direct oral anticoagulants in patients with venous thromboembolism and thrombophilia: a systematic review and meta‐analysis

Journal of Thrombosis and Haemastasis

Review of 8 studies reporting data on 1994 thrombophilia patients found no statistically significant differences in rate of VTE recurrence for DOACs vs vitamin K antagonists (RR 0.79, 95% 0.34-1.44). Bleeding event rates were similar (0.92, 0.62 to 1.36).

 

Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation

New England Journal of Medicine

2 x 2 factorial RCT (n=4,614) found that in those with AF and a recent MI or PCI on a P2Y12 inhibitor; apixaban, without aspirin, resulted in less bleeding and without affecting the incidence of ischaemic events vs regimens including a vitamin K antagonist and/or aspirin.

 

Direct Oral Anticoagulant (DOAC) Dosing in renal impairment

Drug and Therapeutics Bulletin

In light of > 4,000 yellow card reports of DOAC-associated haemorrhagic events since their launch, the author of this editorial highlights the urgent need for national guidance to help clinicians prescribe DOACs safely, particularly for patients with declining renal function.

 

Bayer and Janssen pay $775m to settle more than 25 000 lawsuits in US over rivaroxaban misinformation claims

British Medical Journal
Cardiovascular system disorders | Haematological disorders
Neither company admitted liability. Most plaintiffs argued that rivaroxaban's labelling and instructions did not provide adequate information about risk to patients and clinicians. Janssen said labelling had been approved by US FDA and "clearly communicated benefits and risks."

 

 

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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Reduced risk of gastrointestinal bleeding associated with proton pump inhibitor therapy in patients treated with dual antiplatelet therapy after myocardial infarction

European Heart Journal

Danish registry review of 46,301 pts on dual antiplatelet treatment after MI found only 35% at higher risk of upper gastrointestinal (UGI) bleeding received treatment with PPI based on the guideline criteria. Use of a PPI was associated with a lower 1-year risk of UGI bleedings.

 

Antithrombotic therapy in patients undergoing transcatheter aortic valve implantation

Heart

Review summarises currently available data and suggests a more individualised antithrombotic treatment strategy after transcatheter aortic valve implantation based on risk factors for cardiovascular events and bleeding.

 

Emicizumab (Hemlibra) approved in EU for prevention of bleeding episodes in people with severe haemophilia A without factor VIII inhibitors

PharmaTimes

The decision follows results of the Phase III HAVEN 3 study. Emicizumab is already licensed for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors.

 

 

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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Association of Adding Aspirin to Warfarin Therapy Without an Apparent Indication With Bleeding and Other Adverse Events

JAMA Internal Medicine

US registry-based cohort study (n=6539) reports 37.5% received combination warfarin and aspirin without therapeutic indication for aspirin use; compared with matched controls, higher rates of overall bleeding were reported for those on combination (26.0% vs 20.3%; P<0.001).

 

 

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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NIHR Signal: Prolonging anticoagulant treatment after abdominal cancer surgery reduces clot risk

National Institute for Health Research Signal

An expert opinion is provided of a Cochrane review which concluded that the incidence of venous thromboembolism was reduced in people who have low molecular weight heparin (LMWH) for between two to four weeks after abdominal or pelvic surgery, especially for cancer.

 

Predicting Bleeding Risk to Guide Aspirin Use for the Primary Prevention of Cardiovascular Disease: A Cohort Study

Annals of Internal Medicine

This is an evaluation of prognostic bleeding risk models, with a view to developing a model to be used to estimate the absolute bleeding harms of aspirin among persons in whom aspirin is being considered for the primary prevention of CVD.

 

Antiplatelet Therapy vs Anticoagulation Therapy in Cervical Artery Dissection The Cervical Artery Dissection in Stroke Study (CADISS) Randomized Clinical Trial Final Results

JAMA Neurology

This RCT (n=250) reports risk of recurrent stroke at 1 year was 2.5%, with no difference in recurrence rates or rates of angiographic recanalisation with either antiplatelets or anticoagulants.

 

Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial

European Heart Journal

Pre-specified sub-group analysis (n=2725) reported that benefits of dabigatran dual therapy vs warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without acute coronary syndrome, and patients treated with ticagrelor or clopidogrel.

 

Acute dual antiplatelet therapy for minor ischaemic stroke or transient ischaemic attack

British Medical Journal
BMJ analysis discusses recent evidence and recommends that dual antiplatelet therapy should be started as soon as possible within 24 hours of minor ischaemic stroke or high risk transient ischaemic attack and should be continued up to 21 days.

 

 

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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Concomitant Use of Direct Oral Anticoagulants with Antiplatelet Agents and the Risk of Major Bleeding in Patients with Nonvalvular Atrial Fibrillation

American Journal of Medicine

Study (n=14,407) found during median 1.6 months follow-up, concomitant DOAC-antiplatelet (vs. Vit K antagonist-antiplatelet) linked to similar GI bleeding risk but decreased intracranial bleed risk (HR 0.46; 95% CI, 0.24-0.91) and other major bleeding (0.68; 95% CI, 0.51-0.91).

 

Turoctocog alfa pegol for Haemophilia A approved for use in the US

Biospace Inc.

Approval was on the basis of a trial which found that turoctocog alfa pegol provided effective prophylaxis and that patients were able to maintain a low median annualised bleeding rate of 1.18 on maintenance dosing. It is currently under regulatory review for use in the EU.

 

Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis

New England Journal of Medicine

This RCT in which 2003 adults in ICU were randomised to either pharmacologic thromboprophylaxis alone or in combination with intermittent pneumatic compression, reports no statistically significant difference in incident proximal lower-limb DVT, or death from any cause at 90 days.

 

Efficacy and Safety of Apixaban versus Warfarin in Patients with Atrial Fibrillation and Extremes in Body Weight: Insights from the ARISTOTLE Trial

Circulation

Post-hoc analysis involving 1985 patients ≤60kg, 15,172 patients in the mid-range weight group and 982 patients >120kg reports treatment effect of apixaban vs warfarin for efficacy outcomes of stroke/systemic embolism, all-cause death, or MI was consistent across weight spectrum.

 

Intracerebral haemorrhage during alemtuzumab administration

The Lancet

In this letter, the authors describe the presentation of patients with intracerebral haemorrhage, and suggest that patients whose mean systolic BP increases >20mmHg (or 20% or more throughout the infusion period), might be at high risk of intracranial haemorrhage.

 

 

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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Pharmacist-led virtual clinics to optimise anticoagulation in AF

Public Health England

Over a 12-month period, the programme reviewed over 1500 patients with AF not receiving anticoagulation, which resulted in an additional 1,200 patients being anticoagulated. The 2 CCGs (Lambeth and Southwark) have since seen a 25% reduction in the rate of AF-related stroke.

 

 

 

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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