Items filtered by date: October 2020

Optimal duration of dual antiplatelet therapy after percutaneous coronary intervention with drug eluting stents: meta-analysis of randomised controlled trials

British Medical Journal

Meta-analysis (10 RCT's; n=32 287) found that short term DAPT (<12 months) after drug eluting stent implementation reduced bleeding with no apparent increase in ischaemic complications vs standard 12 month duration, and could be considered for most patients.

 

Acute Stroke Intervention: A Systematic Review

Journal of the American Medical Association

Systematic review (n = 108 082) found that IV thrombolysis remains the standard of care for patients with moderate to severe neurological deficits who present within 4.5 hours of symptom onset.

 

Prevalence and antithrombotic management of atrial fibrillation in hospitalised patients

Heart

US study (n=812) identified high AF prevalence rates (16.8%) across all wards. Most patients with AF were at high risk for stroke; however anticoagulation therapy was considered inappropriate in 48.7%, indicating the need for guideline optimisation especially in non-cardiac wards.

 

Site-Level Variation in and Practices Associated With Dabigatran Adherence

Journal of the American Medical Association

US study (n= 4863) reported wide variability in medication adherence in patients with nonvalvular AF treated with dabigatran. Pharmacist-led monitoring was associated with higher adherence rates as was pharmacist collaboration with clinicians for nonadherant patients.

 

Medicines Evidence Commentary : Acute coronary syndromes: further evidence on duration of dual antiplatelet therapy after drug-eluting stent implantation

National Institute for Health and Care Excellence

Discussion of a RCT which found that continuing dual antiplatelet therapy beyond 12 months after drug-eluting stent implantation reduced the risk of stent thrombosis, and major cardiovascular and cerebrovascular events at 30 months, compared with switching to aspirin monotherapy.

 

 

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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FDA files supplemental New Drug Application for dabigatran (Pradaxa®) for the prophylaxis of DVT and PE following hip replacement surgery

Biospace Inc.

The US FDA has filed an application seeking approval of dabigatran for the prophylaxis of DVT and PE in patients who have had primary elective total hip replacement surgery, based on the results of two Phase III trials (RE-NOVATE and RE-NOVATE II) comparing it to enoxaparin.

 

Investigational anticoagulant reversal agent (PER977) receives FDA Fast Track designation

Biospace Inc.

The FDA has granted Fast Track status for PER977, an investigational anticoagulant reversal agent that directly binds to NOACs, fondaparinux, low molecular weight heparins and unfractionated heparins. It is undergoing development as an IV injection; Phase III studies are planned.

 

Eyes on Evidence: Detecting atrial fibrillation in people who have had a stroke

National Institute for Health and Care Excellence

A commentary is provided on 2 RCTs which reported that long-term ECG monitoring was more effective at detecting AF than 24-hour or intermittent ECG monitoring in people who had experienced apparent cryptogenic stroke or transient ischaemic attack.

 

Antiphospholipid syndrome: A patient’s journey

British Medical Journal

This is last in a series of occasional articles by patients about their experiences that offer lessons to doctors. It illustrates the often long delays
experienced by patients before a diagnosis is made and treatment started.

 

Association Between Perioperative Low-Molecular-Weight Heparin vs Unfractionated Heparin and Clinical Outcomes in Patients With Cancer Undergoing Surgery

Journal of the American Medical Association

Based on 16 trials (n=12 890) there was no difference between LMWH and unfractionated heparin in their associations with mortality, pulmonary embolism, symptomatic DVT, major bleeding, or minor bleeding outcomes in patients with cancer undergoing surgical procedures.

 

Practice Guide for managing a high INR in a patient on warfarin

British Medical Journal

This practice guide, based on a case vignette, outlines the immediate and long-term management of a patient presenting with a high INR whilst on
warfarin.

 

CADTH reviews point-of-care INR testing compared with laboratory INR testing

Canadian Agency for Drugs and Technologies in Health

This review summarises the practical impact of, and cost effectiveness of point-of-care (POC) INR testing compared with lab INR testing concluding that patient self-management (POC INR testing + dose adjustment) may be the most cost-effective option, when feasible, in Canada.

 

 

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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Safety of Intravenous Thrombolysis in Stroke Mimics: Prospective 5-Year Study and Comprehensive Meta-Analysis

Stroke

Shortening door-to-needle time may lead to inadvertent intravenous thrombolysis (IVT) administration in stroke mimics (SMs). Prospective, single-centre experience (n=75) coupled with findings of meta-analysis of 9 studies suggest safety of IVT in SMs.

 

Duration of dual antiplatelet therapy after coronary artery stenting: where is the sweet spot between ischaemia and bleeding?

European Heart Journal

The article discusses dual antiplatelet therapy (DAPT), stable coronary artery disease, acute coronary syndromes, novel evidence, stent types and DAPT, rebound after DAPT cessation, and individualised DAPT management.

 

Cangrelor (Kengrexal™) approved in the EU for use in patients undergoing PCI

Biospace Inc.

The EC has granted marketing authorisation for cangrelor (Kengrexal™) for the reduction of thrombotic cardiovascular events in adults with coronary artery disease undergoing PCI and who have not received an oral P2Y12 inhibitor prior to the procedure.

 

 

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 between brain imaging signs, early and late outcomes, and response to intravenous alteplase after acute ischaemic stroke in the third International Stroke Trial (IST-3): secondary analysis of a randomised controlled trial

The Lancet Neurology

Pre-specified analysis (n=3017) found some early ischaemic and pre-existing signs are linked to reduced independence at 6 months and increased symptomatic intracranial haemorrhage. No interaction was noted between brain imaging signs and effects of alteplase on these outcomes.

 

Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome – guidance (TA 335)

National Institute for Health and Care Excellence

Rivaroxaban is recommended as an option within its marketing authorisation, in combination with aspirin plus clopidogrel or aspirin alone, for preventing atherothrombotic events in people who have had an acute coronary syndrome with elevated cardiac biomarkers.

 

Precision medicine to improve use of bleeding avoidance strategies and reduce bleeding in patients undergoing percutaneous coronary intervention: prospective cohort study before and after implementation of personalized bleeding risks

British Medical Journal

US data reported that pre-procedural risk stratification was associated with an increase in the uptake of bleeding avoidance strategies (bivalirudin, radial approach, and vascular closure devices) leading to a reduction in rates of bleeding, particularly among high risk patients.

 

Microbleeds, Mortality, and Stroke in Alzheimer Disease: The MISTRAL Study

JAMA Neurology

This longitudinal cohort study found that microbleeds in patients with Alzheimer disease increased the risk of CV events (non-lobar bleeds) and stroke (lobar bleeds) and related mortality – even higher risks for such events were found in patients using antithrombotics.

 

 

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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Mortality in patients treated with extended duration dual antiplatelet therapy after drug-eluting stent implantation: a pairwise and Bayesian network meta-analysis of randomised

The Lancet

This meta-analysis concluded that shorter DAPT was associated with lower all-cause mortality compared with longer DAPT (HR 0.82, 95% CI 0.69–0.98; p=0.02; NNT=325). Shorter DAPT was also associated with a lower risk of major bleeding, but a higher risk of MI and stent thrombosis.

 

Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction

New England Journal of Medicine

At 3 years, composite CV death, MI or stroke was reduced in the ticagrelor groups vs placebo (HR 90mg ticagrelor 0.85, 95%CI 0.75-0.96; P=0.008; HR 60mg 0.84; 0.74-0.95; P=0.004). Rates of TIMI major bleeding were higher with ticagrelor than with placebo.

 

Pharmacology of antithrombotic drugs: an assessment of oral antiplatelet and anticoagulant treatments

The Lancet

This paper, the first in a series of three papers, discusses the pharmacological properties of the most commonly used oral antithrombotic drugs, and explores the development of antiplatelet and anticoagulant therapies.

 

Clinical evidence for oral antiplatelet therapy in acute coronary syndromes

The Lancet

This paper, the second in a series of three, describes major trial results for oral antiplatelet use in ACS, implications for clinical practice, and
summarises continuing controversy.

 

Oral anticoagulants for stroke prevention in atrial fibrillation: current status, special situations, and unmet needs

The Lancet

This paper (the third in a series of three) addresses the role of anticoagulation for stroke prevention in AF in the era of NOACs, focussing on special situations including management in the event of bleeding and around the time of procedures.

 

Bivalirudin vs Heparin With or Without Tirofiban During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction The BRIGHT Randomized Clinical Trial

Journal of the American Medical Association

Among patients with AMI undergoing primary PCI (n=2194), the use of bivalirudin post-procedure resulted in a decrease in net adverse clinical events vs both heparin alone and heparin + tirofiban (8.8% vs 13.2% and 17% respectively, p statistically significant for both).

 

What is the risk of gastrointestinal bleeding associated with selective serotonin reuptake inhibitors (SSRIs)?

UKMi

This updated Medicines Q&A evaluates the evidence available on the risk of gastrointestinal bleeding with selective serotonin reuptake inhibitors.

 

Antiplatelet Therapy Duration Following Bare Metal or Drug-Eluting Coronary Stents: : The Dual Antiplatelet Therapy Randomized Clinical Trial

Journal of the American Medical Association

In 1687 patients with bare metal stents who tolerated 12 months of thienopyridine, continuing thienopyridine for an additional 18 months versus placebo did not result in significant differences in rates of stent thrombosis, MACCE, or moderate or severe bleeding.

 

Medicines Evidence Commentary : Medicines adherence: UK study finds evidence for the effectiveness of text messaging on adherence to cardiovascular preventative treatment

National Institute for Health and Care Excellence

Discussion of a UK GP population based randomised trial (the INTERACT trial) of people taking blood pressure and/or lipid–lowering medicines for the prevention of cardiovascular disease (CVD) which assessed the value of text messaging for medicines adherence.

 

Thrombolysis in acute ischaemic stroke: time for a rethink?

British Medical Journal

The authors of this article consider the use of alteplase in the management of acute stroke. They say the evidence suggests use at 3-4.5 hours after onset increases mortality with no clear benefit and believe that current recommendations should be re-evaluated urgently.

 

Medical device alert: INRatio® and INRatio®2 PT/INR coagulation monitor and test strips used at home and at point of care. Manufactured by Alere

Medicines and Healthcare products Regulatory Agency

In people with certain medical conditions, these devices can give low blood coagulation results, which can lead to incorrect anticoagulant dose. This alert advises action to be taken by those working in anti-coagulation clinics and device users or their carers.

 

 

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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Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines

British Medical Journal

This research finds guideline recommendations often don't consider potential drug-drug or -disease interactions that may be present if patients have co-morbidities. The authors call for guideline developers to more explicitly account for multimorbidity in their recommendations.

 

Revised SPC: Plavix™ (clopidogrel) tablets

Annals of Emergency Medicine

Section 4.8 has been updated to include two new undesirable effects - acute generalised exanthematous pustulosis (very rare) and gynaecomastia (rare).

 

Apixaban (Eliquis)

Scottish Medicines Consortium

The SMC has accepted apixaban (Eliquis) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.

 

 

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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Treatment for preventing bleeding in people with haemophilia or other congenital bleeding disorders undergoing surgery

Cochrane Database of Systematic Reviews

There is insufficient evidence from randomised controlled trials to assess the most effective and safe haemostatic treatment to prevent bleeding in people with haemophilia or other congenital bleeding disorders undergoing surgical procedures.

 

Diagnosis of atrial fibrillation after stroke and transient ischaemic attack: a systematic review and meta-analysis

The Lancet Neurology

By sequentially combining cardiac monitoring methods, AF might be newly detected in ~25% patients with CVA/TIA. Proportion with CVA known to have AF seems higher than previously estimated, so more could be treated with oral anticoagulants and more CVA recurrences prevented.

 

Vorapaxar approved for use in the EU for the reduction of atherothrombotic events in adults with a history of MI

European Medicines Agency

The European Medicines Agency has approved vorapaxar (Zontivity®) for use in combination with aspirin and, where appropriate, clopidogrel, for the reduction of atherothrombotic events in adult patients with a history of myocardial infarction.

 

Efficacy of Antiplatelet Therapy in Secondary Prevention Following Lacunar Stroke: Pooled Analysis of Randomized Trials

JAMA Stroke

Analysis of data from 17 trials (n=42,234, follow up 4 wks-3.5 yrs) found that use of any single antiplatelet agent was linked to significant reduction in recurrence of any stroke (risk ratio 0.77, 0.62–0.97, 2 trials) and ischaemic stroke (0.48, 0.30–0.78, 2 trials) vs. placebo.

 

Digoxin use in patients with AF and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in AF

The Lancet

In 14,171 patients, digoxin (DG) was used at baseline in 5239 (37%). DG was linked to significant increase in all-cause mortality, vascular death, and sudden death in patients with AF. A randomised trial of DG in treatment of AF patients with and without heart failure is needed.

 

NICE issues Final Appraisal Determination on apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism

National Institute for Health and Care Excellence

DRAFT guidance supports use of apixaban, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults. Anticipated publication date of guidance is June 2015.

 

 

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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Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation: a pre-specified analysis from the PRODIGY

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.

 

6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin : The Randomized, Multicenter ITALIC Trial

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.

 

Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial

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.

 

Alteplase versus tenecteplase for thrombolysis after ischaemic stroke (ATTEST): a phase 2, randomised, open-label, blinded endpoint study

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.

 

Anticoagulant Reversal, Blood Pressure Levels, and Anticoagulant Resumption in Patients With Anticoagulation-Related Intracerebral Hemorrhage

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.

 

Association of NSAID Use With Risk of Bleeding and Cardiovascular Events in Patients Receiving Antithrombotic Therapy After Myocardial Infarction

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:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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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.

 

Edoxaban vs. warfarin in vitamin K antagonist experienced and naive patients with atrial fibrillation

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.

 

Association Between the Use of Fondaparinux vs Low-Molecular-Weight Heparin and Clinical Outcomes in Patients With Non–ST-Segment Elevation Myocardial Infarction

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.

 

Comparative Risk of Ischemic Stroke Among Users of Clopidogrel Together With Individual Proton Pump Inhibitors

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:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

 

 

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Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial

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.

 

Medicines Evidence Commentary: Medicines optimisation: identifying medicines associated with serious medication errors

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.

 

EMA receives marketing authorisation application for eltrombopag to include children with chronic immune (idiopathic) thrombocytopenic purpura

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:

http://www.evidence.nhs.uk/about-evidence-services/content-and-sources/medicines-information/new-medicines-awareness-services

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