Annals of Internal Medicine
Retrospective analysis of 1970 patients undergoing PCI reports prolonged dual-antiplatelet therapy (DAPT) resulted in harm in patients with low DAPT scores but reduced risk for ischaemic events in patients with high scores receiving paclitaxel-eluting stents.
Antithrombotic treatment after stroke due to intracerebral haemorrhage
Cochrane Database of Systematic Reviews
This review of two RCTs (n=121) concludes there is insufficient evidence to support or discourage the use of antithrombotic treatment after ICH. RCTs comparing starting vs avoiding antiplatelets /anticoagulants after ICH appear justified and are needed in clinical practice.
British Journal of General Practice
Analysis (2004-2012) found presence/absence of recorded contraindications (CIs) has little influence on decision to prescribe anticoagulants (ACs) for prevention of stroke in AF patients. Nationally, 38,000 with AF and CIs were treated with ACs, which has safety implications.
It Is Time to End the Dualistic Short Versus Long Duration of Dual Antiplatelet Therapy Debates
Circulation
Viewpoint suggests it is time to end academic debate and begin clinical discussion, with a shift in focus away from dualistic short versus long duration thinking and towards discussions on which patients are best treated with short, standard or prolonged dual antiplatelet therapy.
Journal of the American Medical Association
Viewpoint notes that based on available, evidence, there is no clear link between antiplatelet strategy and rates of perioperative major adverse CV events and bleeding, even though physiological reasons would suggest that antiplatelet agents should be a factor in the risk of both.
Heart
This review notes that in the absence of RCT evidence, patient-specific factors such as dosing preference (daily vs twice a day), renal function, liver function, gastrointestinal bleeding risks and drug–drug interactions can help guide treatment choice.
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
Management of superficial venous thrombosis of the leg
Drug and Therapeutics Bulletin
Review notes lack of consensus on best treatment but oral NSAIDs and compression stockings are used to provide symptomatic relief for pain and swelling. Guidelines suggest that fondaparinux or a low molecular weight heparin are options for some high risk patients.
The Lancet Haematology
RCT (n=100, Austria) was terminated early for futility and safety reasons because compared to patients on coagulation factor concentrates, a higher proportion of patients receiving fresh frozen plasma required rescue therapy (52 vs. 4%) and massive transfusion (30 vs. 12%).
European Heart Journal
Paper notes that while available clinical data for specific antidotes of NOACs are limited, it is very likely these agents will successfully reverse.
Thrombophilia Testing in Provoked Venous Thromboembolism: A Teachable Moment
JAMA Internal Medicine
This Teachable Moment looks at the value of testing for inherited thrombophilia in patients with provoked venous thrombophilia.
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
The treatment of paroxysmal atrial fibrillation in UK primary care
Heart
The proportion of patients with a CHADS2 score of ≥1 prescribed anticoagulants increased between 2000 and 2015. Although improved, use in those with paroxysmal AF remains lower in 2015 (56.2% versus 69.4% in patients with persistent/permanent AF, RR 0.76; 95% CI 0.74 to 0.77).
Diagnosis and management of deep vein thrombosis in pregnancy
British Medical Journal
The incidence of DVT among pregnant women is around 1.1 per 1000 deliveries. This article provides an update on the diagnosis and management of pregnant women with DVT.
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
Clopidogrel reloading for patients with acute myocardial infarction already on clopidogrel therapy
European Heart Journal
This analysis of patients admitted to hospital with myocardial infarction who were on clopidogrel pre-admission (n=12,366 STEMI and 39,158 NSTEMI) found that reloading (75.8% STEMI and 25.9% NSTEMI) was not associated with increased risk of major bleeding or mortality.
Specific antidotes for bleeding associated with direct oral anticoagulants
British Medical Journal
This BMJ 'Practice' article discusses strategies to reverse anticoagulant activity of direct oral anticoagulants (DOACs), focusing on newer specific antidotes (idarucizumab [the only one currently licensed]; andexanet alfa, and ciraparantag).
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
Cochrane Database of Systematic Reviews
Updated review of 3RCTs (n=1398) demonstrated low-quality evidence of a lower incidence of heparin-induced thrombocytopenia (HIT), and HIT complicated by venous thromboembolism, in postoperative patients undergoing thromboprophylaxis with LMWH compared with UFH.
Influence of Direct Oral Anticoagulants on Rates of Oral Anticoagulation for Atrial Fibrillation
Journal of the American College of Cardiology
Study (n=655,000; CHA2DS2-VASc >1) in US found introduction of DOACs into routine practice linked to improved rates of overall oral anticoagulant use (from 52.4% to 60.7%; p<0.01; warfarin use decreased 52.4% to 34.8%; DOAC use increased 0% to 25.8%) but significant gaps remain.
Anticoagulation in patients with isolated distal deep vein thrombosis: a meta-analysis
Journal of Thrombosis and Haemastasis
Review of 20 studies (n= 2,936) found that anticoagulation (therapeutic or prophylactic) reduced to the risk of VTE vs no anticoagulation (OR 0.5, 95% CI 0.31-0.79). There was no significant difference in major bleeding risk (OR 0.64, 0.15-2.73).
FDA grant fast track designation for SB-525 gene therapy for haemophillia
PharmaTimes
SB-525 uses a recombinant adeno-associated virus (rAAV) to deliver a human Factor VIII cDNA construct. This treatment also has orphan designation in the US. EU development plans are unknown.
Revised SPC: Pradaxa (dabigatran etexilate) hard capsules – all strengths
electronic Medicines Compendium
The colour of Pradaxa caps have been changed according to dosage strength, as part of the worldwide harmonisation process.
electronic Medicines Compendium
The Prescriber guide for primary prevention of venous thromboembolic events following elective hip or knee replacement surgery provides recommendations for orthopaedic use with the aim of minimising risk of bleeding, and providing guidance on how to manage that risk.
European Heart Journal
RCT (n=645) reports switching dual antiplatelet therapy (DAPT) from aspirin + newer P2Y12 blocker to clopidogrel after 1 month results in occurrence of primary endpoint (composite CV death, urgent revascularisation, stroke and bleeding) of 26.3% vs 13.4% respectively (P < 0.01).
Educational Risk Minimisation Materials for Clexane (enoxaparin sodium)
Sanofi UK
Dear Healthcare Professional" letter notes that enoxaparin is expressed both in international units (IU) of anti-Xa activity and in milligrams (mg); and that its use in severe renal impairment is not recommended. There is also further clarification on dose regimens for DVT/PE.
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
Integrated care in atrial fibrillation: a systematic review and meta-analysis
Heart
The results of this analysis suggest that use of an integrated model of care delivery in AF, with multidisciplinary team and community supports to ensure patient involvement in their management and decisions involving their care, is associated with enhanced patient outcomes.
British Medical Journal
Cohort review (446,763 individuals) found an increased risk for myocardial infarction with the use of several NSAIDs for 1-7 days; ibuprofen, HR 1.48 (95% CI 1.00 to 2.26), diclofenac 1.50 (1.06-2.04), naproxen 1.53 (1.07-2.33) and rofecoxib, 1.58 (1.07-2.17).
Pharmacovigilance Risk Assessment Committee (PRAC) review of factor VIII medicines
European Medicines Agency
This review has concluded that there is no clear and consistent evidence of difference in the incidence of inhibitor development between the plasma-derived and recombinant DNA technology-derived classes of factor VIII medicines.
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
Trends in the prescription of novel oral anticoagulants in UK primary care
British Journal of Clinical Pharmacology
Data from the UK CPR Datalink (between 2009-2015) shows the overall rate of oral anticoagulant initiation increased by 58% over the study period despite the rate of new VKA use decreasing by 31%. The rate of initiation of NOAC increased, with a 17-fold increase from 2012 to 2015.
Gastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study
Gastroenterology
This study (n=43,303) found GI bleeding occurred more frequently with rivaroxaban than dabigatran (HR, 1.20; 95% CI, 1.00-1.45), whereas apixaban was associated with lower bleeding risk than dabigatran (0.39; 0.27-0.58; P <0.001) or rivaroxaban (0.33; 0.22-0.49; 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
American Journal of Cardiology
Meta-analysis of 9 RCTs (n= 106,288) suggests that overall, ticagrelor may have the best net efficacy and safety profile among currently approved oral P2Y12 inhibitors for the treatment of acute coronary syndrome.
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
European Heart Journal
This analysis of UK data reports that all three diseases were associated with an increased risk of venous thromboembolism, highest for rheumatoid arthritis (HR 1.29; 95% CI 1.18–1.39 for no DMARD and 1.35, 95% CI 1.27–1.44 for DMARD). An interaction with DMARDs was significant.
Treatment of Patients With Atrial Fibrillation and Heart Failure With Reduced Ejection Fraction
Circulation
This review discusses the available data for the treatment of AF in patients who have heart failure with reduced ejection fraction, looks at areas where more investigation is necessary, and presents suggestions for individualised treatment strategies for specific patient groups.
European Heart Journal
Review of 5 RCTs (n=1,730) found that patients treated with bioresorbable vascular scaffolds had a higher risk of device thrombisis vs those treated with everolimus eluting stents (OR 2.93, 95% CI 1.37-6.26). There was no statistical difference in risk of target lesion failure.
NIHR Signal: Thrombolysis may reduce complications of deep vein thrombosis
National Institute for Health Research Signal
Expert commentary is provided for a systematic review which found that thrombolysis reduced the risk of post-thrombotic syndrome. This benefit however would come at the cost of and increased risk of bleeding. The role of thrombolysis in deep vein thrombosis requires clarification.
Anticoagulation reversal for supratherapeutic International Normalized Ratio: A teachable moment
JAMA Internal Medicine
This article describes a case report of a woman in her 80s who underwent anticoagulation reversal, and highlights that fresh frozen plasma transfusions in certain patients with non-urgent conditions can lead to transfusion-associated circulatory overload.
Potent P2Y12 Inhibitors in Men Versus Women A Collaborative Meta-Analysis of Randomized Trials
Journal of the American College of Cardiology
Meta-analysis of 7 studies (n=87,840) found no significant difference in efficacy (reduction in risk of major cardiovascular adverse events, myocardial infarction, and stent thrombosis) or safety (major bleeding) for the use of P2Y12 inhibitors in men and women.
The Lancet Haematology
Danish cohort study (n=4,679 propensity matched patients) found lower rates of recurrent VTE at 6 months for rivaroxaban compared to warfarin (9.9 incidents per 100 person-years vs 13.1 HR 0.74, 95%CI 0.56-0.96). Bleeding rates were similar.
Journal of Vascular Surgery
Study (n=9179) found perioperative clopidogrel (vs. non use) in lower extremity bypass surgery is linked to increased blood loss (21% vs 12%; p<0.001) and blood transfusion (38% vs 24%; p<0.001), with associated clinical sequelae of increased cardiac and pulmonary complications.
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
Journal of the American College of Cardiology
Meta-analysis of 4 RCTs noted that in this population without moderate/severe mitral stenosis/mechanical heart valves, NOACs seem attractive alternatives to vitamin K antagonists because coexistence of valvular heart disease does not affect overall relative efficacy/safety.
Predicting the risk of bleeding during dual antiplatelet therapy after acute coronary syndromes
Heart
Paper reports that long-term bleeding risk during dual antiplatelet therapy (DAPT) for patients with ACS can be reliably predicted with selected baseline characteristics using TRILOGY ACS bleeding risk models thus informing risk–benefit considerations regarding DAPT duration.
Stability of repackaged dabigatran etexilate capsules in dose administration aids
European Journal of Hospital Pharmacy
Study reports storage of capsules at ambient conditions for 14 and 28 days resulted in % drug remaining of 92.5% and 71.6%, respectively. In contrast, repackaged capsules stored in fridge for 28 days had drug content of 98.2% and dissolution was not significantly affected.
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
