Anticoagulation news items. Week commencing 23rd February 2015
European Heart Journal
This study(n=1970) suggests clinical presentation may be treatment modifier with respect to DAPT duration post stenting consistent with theory that stable CAD but not ACS-patients are exposed to significant increase in bleeding/net adverse clinical events with 24 vs. 6-month therapy.
Journal of the American College of Cardiology
RCT in good aspirin responders which was prematurely terminated due to recruitment problems (n=941 on 24-month and 953 on 6-month DAPT), found that rates of bleeding and thrombotic events were not significantly different between the 2 groups after PCI with new-generation DES.
The Lancet
RCT (n=181) found addition to vitamin K (VK) of single dose of four-factor prothrombin complex concentrate was non-inferior and superior to addition of plasma for rapid INR reversal and effective haemostasis in patients needing VK antagonist reversal pre-operatively.
Factor Xa inhibitor antidote andexanet alfa receives orphan drug designation in US
Biospace Inc.
Andexanet alfa is intended for reversing anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery. Currently, there is no approved antidote for these patients.
The Lancet Neurology
This Scottish RCT in 104 (71 analysed) adults with supratentorial ischaemic stroke eligible for intravenous thrombolysis within 4.5 hours of onset found that neurological and radiological outcomes did not differ between the tenecteplase and alteplase groups.
Journal of the American Medical Association
This retrospective cohort study of patients with oral anticoagulant (OAC)-associated ICH found reversal (INR <1.3 within 4 hours) and systolic
BP <160mmHg at 4 hours were associated with reduced rates of haematoma enlargement, and OAC resumption reduced rates of ischaemic events.
Journal of the American Medical Association
An analysis of Danish registry data (n=61,971) found that use of NSAIDs among adults receiving antithrombotic therapy after a first MI was associated with an increased risk of bleeding requiring hospitalisation (HR 2.02) and an excess of cardiovascular events (HR 1.40).
Venous Thromboembolism - Reducing the risk: addendum consultation
National Institute for Health and Care Excellence
NICE is currently updating its guidance on 'Venous thromboembolism - reducing the risk' following new evidence identified on intermittent pneumatic compression for preventing VTE in hospitalised stroke patients. New DRAFT recommendations have been published for consultation.
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:
Anticoagulation news items. Week commencing 16th February 2015
Vorapaxar in Patients With Diabetes and Prior MI: Findings from the TRA 2°P-TIMI 50 Trial
Circulation
In this subgroup analysis of patients with DM and recent MI (n=3,623), vorapaxar reduced the composite primary endpoint of CV death, MI, or stroke at 3 years (11.4% vs. 14.3%, HR 0.73, 95% CI 0.60-0.89; p=0.002) with a number needed to treat to avoid 1 major CV event of 29.
European Heart Journal
In this subgroup analysis of patients with/without prior VKA exposure, higher-dose edoxaban reduced risk of stroke or systemic embolic events in patients who were VKA naive (HR 0.71, 95% CI 0.56–0.90) and was similar to warfarin in the VKA experienced (HR 1.01, 0.82–1.24; P=0.028.
Journal of the American Medical Association
Swedish registry data (40,616 consecutive patients with NSTEMI) identified that fondaparinux was associated with lower odds than LMWH of major bleeding events and death both in-hospital and up to 180 days afterwards. These data are consistent with trial data.
Stroke
PPIs evaluated in this study (esomeprazole, lansoprazole, omeprazole, rabeprazole) of 325,559 concomitant users of clopidogrel and a PPI, did not increase the rate of ischaemic stroke vs. pantoprazole, a PPI thought to be devoid of the potential to interact with clopidogrel.
Atrial fibrillation: quality standard consultation
National Institute for Health and Care Excellence
This quality standard for adults with atrial fibrillation (AF) is expected to contribute to improvements in rates of: mortality, stroke and transient ischaemic attack, admission with a primary diagnosis of AF, and quality of life.
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:
Anticoagulation news items. Week commencing 9th February 2015
The Lancet Neurology
Pilot study data (n=250) found no difference in efficacy of antiplatelet and anticoagulant drugs at preventing stroke and death in patients with symptomatic carotid and vertebral artery dissection. However, stroke events were rare in both groups.
National Institute for Health and Care Excellence
Discussion of a systematic review which has identified those medicines reported in the literature that most commonly cause serious adverse reactions because of medication errors.
Biospace Inc.
A variation in Marketing Authorisation has been submitted to the EMA for the use of eltrombopag (Revolade) for the treatment of children >1 year with chronic immune (idiopathic) thrombocytopenic purpura who have had an insufficient response to corticosteroids or immunoglobulins.
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:
Anticoagulation news items. Week commencing 2nd February 2015
National Institute for Health and Care Excellence
Discussion of a systematic review and meta-analysis published in 2014 in the American Journal of Cardiology which explored whether apixaban is superior to conventional agents with regard to bleeding complications in the subset of people with renal failure.
British Medical Journal
Among 12, 403 older Canadian adults with AF who started warfarin, rates of major bleeding were significantly higher in those with lower eGFR, particularly during the first 30 days of treatment. The NNH was 22 during the first 30 days vs 206 in the remainder of the follow-up.
Revised SPC: Revolade (eltrombopag)
electronic Medicines Compendium
Section 4.8 (undesirable effects) has been updated based on the latest pooled analysis of adverse events/ adverse drug reactions for ITP-controlled trials.
JAMA Neurology
This retrospective analysis found that use of thrombolysis after mild stroke (poorly represented in thrombolytic trials) was associated with infrequent complications; however 30% could not ambulate independently at discharge and 29.4% could not go directly home.
Revised SPC: Pradaxa tablets (dabigatran etexilate mesilate) – all strengths
electronic Medicines Compendium
Sections 4.8 and 5.1 have been updated to include new safety and efficacy data.
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
Anticoagulation news items. Week commencing 26th January 2015
Revised SPC: Xarelto (rivaroxaban) – all strengths
electronic Medicines Compendium
A new paragraph on neuraxial (epidural/spinal) anaesthesia has been added to section 4.4 (all strengths), and new information on patients undergoing cardioversion has been added to sections 4.2 and 5.1 (15mg and 20mg strengths).
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
Anticoagulation news items. Week commencing 19th January 2015
Rivaroxaban for acute coronary syndrome: final appraisal determination
National Institute for Health and Care Excellence
In DRAFTguidance, NICE supports use of rivaroxaban, in combination with aspirin plus clopidogrel or aspirin alone, for preventing atherothrombotic events in people who have had an ACS with elevated cardiac biomarkers. Bleeding risk should be assessed before treatment is started.
Journal of Clinical Oncology
An evidence update which included a review of 53 publications, found that the 2014 recommendations are consistent with the 2013 recommendations.
Patient Safety Alert (stage one): Harm from using Low Molecular Weight Heparins when contraindicated
NHS England
Consideration of contraindications is a prominent feature of available local and national guidance for prescribing and administering LMWHs. This stage one Patient Safety Alert aims to reinforce the need for reliable systems to ensure that this always occurs.
Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis
Circulation
A US report found approx 5.9% of end-stage renal disease patients with AF are started on dabigatran or rivaroxaban despite the drugs being contraindicated in these patients; both were associated with a higher risk of hospitalisation or death from bleeding compared to warfarin.
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:
Anticoagulation news items. Week commencing 12th January 2015
Clinical Cardiology
In a large observational study of 27,467 patients on rivaroxaban, the major bleeding rate (496 events in 478 patients; incidence of 2.86 per 100 person-years) was generally consistent with the registration trial results, and fatal bleeds were rare (0.08 per 100 person-years).
Biospace Inc.
A Phase IV study of the investigational Factor Xa inhibitor antidote andexanet alfa in patients receiving apixaban, rivaroxaban or enoxaparin who present with an acute major bleed has been initiated to support its approval by the FDA under an Accelerated Approval pathway.
Ultrasound enhanced catheter-directed thrombolysis for pulmonary embolism: consultation
National Institute for Health and Care Excellence
This DRAFT guidance states there is inadequate evidence of any enhancement of thrombolysis with ultrasound-enhanced, catheter-directed thrombolysis (CDT) over CDT alone for PE; it should only be used with special arrangements for clinical governance, consent and audit or research.
Stroke
US analysis (n=32,690 with intracerebral haemorrhage) found <20% receive prophylactic anticoagulation for DVT during hospital stay, even though this is safe to do after cessation of haematoma growth, and when used, time to initiation is <2 days in less than half of patients.
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
Anticoagulation news items. Week commencing 5th January 2015
Heart
Managementof this patient group remains difficult and controversial. There is no ideal anticoagulation regimen as there are inherent risks and benefits of each approach for both mother and foetus. There are limited data on optimal treatment strategy for an individual patient.
FDA approves licensing of edoxaban (Savaysa) tablets
US Food and Drug Administration
The FDA has approved edoxaban, a factor Xa inhibitor, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Annals of Internal Medicine
This cohort study found a 6.7% per patient-year (PPY) risk for recurrent VTE in patients with a first unprovoked proximal DVT or PE who had a negative d-dimer test result during anticoagulant therapy and 1 month after withdrawal; the recurrence risk was higher in men (9.7% PPY).
European Heart Journal
The authors of this discussion conclude it may be necessary to exclude aspirin for stroke prevention in AF (without comorbid conditions requiring its use) from all AF guidelines, as done by NICE, to remove the 'soft option' of prescribing a drug that is neither effective nor safe.
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
Anticoagulation news items. Week commencing 22nd and 29th December 2014
Biospace Inc.
BAX111 is the first highly-purified recombinant von Willebrand Factor in clinical development, as a treatment option for patients with von Willebrand disease. BAX111 has orphan-drug designation in the EU.
Biospace Inc.
The license extension application will be for use in children aged over 6 years who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Currently, eltrombopag is not licensed in any country for treatment of chronic ITP in the paediatric setting.
Duration of Anticoagulation for Venous Thromboembolic Events
Circulation
This review, based on a case vignette, discusses the evidence for anticoagulant selection and the recommended duration of therapy in patients presenting with venous thromboembolic events
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
Anticoagulation news items. Week commencing 15th December 2014
Outpatient versus inpatient treatment for acute pulmonary embolism
Cochrane Database of Systematic Reviews
Current very low quality evidence from one published RCT did not provide sufficient evidence to assess efficacy and safety of outpatient versus inpatient treatment for acute PE in overall mortality, bleeding and recurrence of PE adequately.
A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke
New England Journal of Medicine
RCT (n=500) found intraarterial treatment (IAT) given within 6 hours after stroke led to shift in distribution of score on modified Rankin scale at 90 days vs. usual care in favour of IAT (OR 1.67; 95% CI, 1.21 to 2.30) and likewise in proportion who were functionally independent.
Biospace Inc.
The submission was based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which evaluated rFVIII administered in two-to-three-times-per-week prophylaxis dosing regimens.
National Institute for Health and Care Excellence
Dabigatran etexilate is recommended, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults.
European Heart Journal
In the ARISTOTLE study, major bleeds were associated with an increased risk of death, ischaemic stroke, or MI, especially following intracerebral haemorrhage. This risk was similarly elevated regardless of whether the patient was treated with apixaban or warfarin.
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
