Items filtered by date: December 5752

Long-term risk for major bleeding during extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A Systematic Review and Meta-analysis

Annals of Internal Medicine
Review (14 RCTs;13 cohort studies; n=17,202) found long-term risks & consequences of anticoagulant-related major bleeding are considerable in this population (incidence/100 person-years =1.74 events with VKAs & 1.12 events with DOACs;5-year cumulative incidence with VKAs was 6.3%.

 

Utilization and long-term persistence of direct oral anticoagulants among patients with nonvalvular atrial fibrillation and liver disease

British Journal of Clinical Pharmacology
UK study (n=3167; 71% on DOACs; 29% vitamin K antagonists [VKA]) found initiators of DOACs were more likely to have prior ischemic stroke (OR 1.44), less likely to have used antiplatelets (OR 0.66) and more likely to persist with treatment at 5 years vs VKAs (31% vs 9%).

 

 

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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Effects of Antiplatelet Therapy After Stroke Caused by Intracerebral Hemorrhage: Extended Follow-up of the RESTART Randomized Clinical Trial

JAMA Neurology
UK RCT (n=537; median 3-year follow-up), found no difference in recurrent intracerebral haemorrhage (8.2% with antiplatelet therapy [AT] vs 9.3% without AT; adjusted HR, 0.87; 95% CI, 0.49-1.55; P = 0.64) or major vascular events (26.8 vs 32.5%; 0.79; 0.58-1.08; P = 0.14).

 

Effects of oral anticoagulation for atrial fibrillation after spontaneous intracranial haemorrhage in the UK: a randomised, open-label, assessor-masked, pilot-phase, non-inferiority trial

The Lancet Neurology
SoSTART RCT (n=218) did not confirm non-inferiority of starting oral anticoagulation (OAC) vs avoiding OAC for recurrent intracranial haemorrhage: 8% vs 4%; adjusted HR 2.42; 95% CI 0.72–8.09; p=0.152) with no difference in serious adverse events (17% vs 15%).

 

De-Escalation of Dual Antiplatelet Therapy in Patients WithAcute Coronary Syndromes

Journal of the American College of Cardiology
In analysis (15 RCTs;n=55,798), DAPT with aspirin & de-escalation from standard-dose potent P2Y12inhibitor (ticagrelor or prasugrel[PG]) to clopidogrel or low-dose PG 1 month after PCI was linked to fewer bleeding events vs. other DAPT strategies & no increase in ischaemic events.

 

Utility of Intravenous Alteplase Prior to Endovascular Stroke Treatment: A Systematic Review and Meta-analysis of RCTs

Neurology
Review (3 studies, n=1092) detected no differences in functional outcomes at 3 months with direct endovascular treatment compared to combination of endovascular treatment preceded by IV thrombolysis in patients with an acute large vessel occlusion.

 

 

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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Thrombolytic therapy for pulmonary embolism

Cochrane Database of Systematic Reviews
Review (21 RCTs [3 new]; n=2401) found low‐certainty evidence suggesting thrombolytics may reduce death following acute PE compared with heparin and may be helpful in reducing the recurrence of pulmonary emboli, but may cause more major and minor haemorrhagic events.

 

Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk

New England Journal of Medicine
In people at high risk of bleeding after implantation of drug-eluting stent (n=4434), 1 month of dual antiplatelet therapy was non-inferior to continuation for ≥2 additional months with regard to occurrence of net adverse clinical events and major adverse cardiac/cerebral events.

 

Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR

New England Journal of Medicine
In this study (n=1426), edoxaban was non-inferior to vitamin K antagonists in terms of the primary composite endpoint (death, MI, ischaemic stroke, systemic thromboembolism, valve thrombosis, major bleeding) in people with AF after successful TAVR (HR 1.05; 95% 0.85-1.31; p=0.01).

 

2021 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines for the management of valvular heart disease

European Heart Journal
This updated guideline considers new evidence in this area, leading to a number of new recommendations, including use of anti-thrombotic therapies in patients with surgical or transcatheter bioprostheses for bridging during perioperative periods and over the long term.

 

 

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: Xarelto (rivaroxaban) 1mg/ml granules for oral suspension and film coated tablets – all strengths

electronic Medicines compendium
SPC updated to include warning that patients with cancer may be at higher risk of bleeding and thrombosis and the individual benefit should be weighed against risk for bleeding in patients with active cancer dependent on tumour location, antineoplastic therapy & stage of disease.

 

Ticagrelor monotherapy in patients with chronic kidney disease undergoing percutaneous coronary intervention: TWILIGHT-CKD

European Heart Journal
This prespecified sub-analysis of the TWILIGHT trial (n=6835) found among CKD patients undergoing PCI, ticagrelor monotherapy reduced the risk of bleeding vs ticagrelor plus aspirin (4.6% vs. 9.0%; ) [HR 0.50, 95% CI 0.31–0.80)] without a significant increase in ischaemic events.

 

Compression stockings for preventing deep vein thrombosis in airline passengers

Cochrane Database of Systematic Reviews
Review (12 RCTs; n=2918) found high‐certainty evidence of a substantial reduction in incidence of symptomless DVT, low‐certainty evidence that leg oedema is reduced, and moderate‐certainty evidence that superficial vein thrombosis may also be reduced, with compression stockings.

 

Heparin Resistance — Clinical Perspectives and Management Strategies

New England Journal of Medicine
This review discusses inhibition of coagulation, identification of heparin resistance, diagnostic tests, mechanisms of resistance, testing and treatment.

 

Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial

European Heart Journal
Analysis of VOYAGER trial (n=6564) found the efficacy and safety outcomes for rivaroxaban in peripheral artery disease (PAD) were consistent across patient age. Authors state these results suggest rivaroxaban plus aspirin can be considered for PAD regardless of age.

 

 

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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Gastrointestinal bleeding risk following concomitant treatment with oral glucocorticoids in patients on non-vitamin K oral anticoagulants

Heart
Danish registry study (n=98,376) found an increased risk of gastrointestinal bleeding in patients exposed to oral glucocorticoids and DOACs vs those only on DOACs (60 day risk of bleed = 0.71% vs 0.38%, RR 1.89, 95%CI 1.43-2.36).

 

Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period

Cochrane Database of Systematic Reviews
Review (29 trials; n=3839) found evidence is very uncertain about benefits/harms of VTE thromboprophylaxis in women during pregnancy and the early postnatal period at increased risk of VTE. As large definitive trials unlikely to be funded, high‐quality registry data are important.

 

Venous thromboembolism in adults- quality standard (QS201)

National Institute for Health and Care Excellence
This updates and replaces quality standards on venous thromboembolism in adults: reducing the risk in hospital (published June 2010), and venous thromboembolism in adults: diagnosis and management (published March 2013).

 

 

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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Cerebral venous thrombosis after vaccination against COVID-19 in the UK: a multicentre cohort study

The Lancet
Review of 95 cases of cerebral VTE after COVID vaccine found 70 classed as vaccine-induced immune thrombotic thrombocytopenia (VITT). Death or dependency was more common in VITT cases. Non-heparin anticoagulants & IV immunoglobulin reduced risk of death or dependency in VITT.

 

Edoxaban in Cardiovascular Disease Management: Review

British Journal of Clinical Pharmacology
This review provides a detailed outline of the growing indications, including thromboembolic and peripheral arterial disease, evidence for use in special populations, pharmacogenetics, and side effect profile of edoxaban.

 

Effect of Rivaroxaban and Aspirin in Patients with Peripheral Artery Disease Undergoing Surgical Revascularization: Insights from the VOYAGER PAD Trial

Circulation
Subgroup analysis (2185 of 6564) found rivaroxaban linked to lower incidence of composite endpoint of acute limb ischaemia, major vascular amputation,MI,CVA, or CVD vs placebo (18.4 vs 22.0% with cumulative incidence at 3 yrs of 19.7 & 23.9%,respectively;HR 0.81;95% CI 0.67-0.98).

 

Bleeding and thrombotic risk in pregnant women with Fontan physiology

Heart
Retrospective cohort study (n=84 undergoing 108 pregnancies) found current antithrombotic strategies appear effective at attenuating thrombotic risk (3 [2.8%] pregnancies complicated by thrombotic events) but with high (>30% bleeding risk, of which 13% life threatening).

 

Clinical Features of Vaccine-Induced Immune Thrombocytopenia and Thrombosis

New England Journal of Medicine
Study (n=294, UK) reported overall mortality was 22% and was highest (73%) among patients with a low platelet count (<30,000/cubic millimetre) and intracranial haemorrhage. Treatment remains uncertain, but identification of prognostic markers may help guide effective management.

 

Clexane ® (enoxaparin sodium) device – Important Information regarding differences between PREVENTIS and ERIS needle guard safety systems

Sanofi UK
From August 2021, Clexane pre-filled syringes with both ERIS and PREVENTIS safety systems will be in the supply chain simultaneously. This healthcare professional communication highlights the differences in the needle guard safety systems between the two devices.

 

 

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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Determinants for under- and overdosing of direct oral anticoagulants and physicians' implementation of clinical pharmacists' recommendations

British Journal of Clinical Pharmacology
Study of 1688 patients with AF on DOACs reports inappropriate prescribing in 16.9% with underdosing more prevalent vs overdosing (9.7% vs 6.9%). Pharmacist advice was accepted in 72% of cases. 51.4% of advices were for underdosing 45.8% for overdosing & 2.8% for contraindications.

 

Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease

Journal of the American College of Cardiology
After median 23 months follow up, COMPASS trial (n=27,395) found combination of rivaroxaban and aspirin, vs aspirin alone, reduced overall (3.4% vs 4.1%; HR: 0.82; 95% CI: 0.71-0.96) and CV mortality (1.7% vs 2.2%; HR: 0.78; 95% CI: 0.64-0.96) but not non-CV death.

 

Antiplatelet therapy in patients with conservatively managed spontaneous coronary artery dissection from the multicentre DISCO registry

European Heart Journal
This study (n=199) found dual antiplatelet therapy (DAPT) was associated with a higher rate of major adverse cardiovascular events compared to single antiplatelet therapy (SAPT) after 1 year-follow up (18.9% vs. 6%) [HR 2.62; 95% CI 1.22–5.61; P=0.013].

 

Non-vitamin K antagonist oral anticoagulants, proton pump inhibitors and gastrointestinal bleeds

Heart
This cohort study (n=164,290) found PPI use was linked to lower rate of upper GI bleed (UGIB) rates (IRR: 0.75; 95% CI: 0.59 to 0.95). PPI's had the largest protective effect in the patient group with a HAS-BLED score of ≥3 (IPW IRR 0.51; 95% CI: 0.35 to 0.77).

 

Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

New England Journal of Medicine
RCT was stopped when prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data for 1098 patients found no significant difference in organ support–free days (1 vs 4 for usual-care thromboprophylaxis) or in percentage who survived to hospital discharge.

 

Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

New England Journal of Medicine
RCT (n=2219) found therapeutic-dose anticoagulation with heparin increased probability (98.6%; OR 1.27; 95% CI, 1.03-1.58) of survival to hospital discharge vs. usual-care thromboprophylaxis, with reduced use of CV or respiratory organ support.

 

Switching of oral anticoagulants in patients with non-valvular atrial fibrillation: A narrative review

British Journal of Clinical Pharmacology
Review of 39 articles published after 2013 noted decision to switch was often related to safety issues (usually bleeding), poor anticoagulation control and ease-of-use. Limited data suggest switching did not have significant impact on risk of stroke and other thrombotic outcomes.

 

Management of acute coronary syndromes in older adults

European Heart Journal
Review focuses on evidence-based interventional and pharmacological approaches, noting that more powerful strategies of antithrombotic therapy for secondary prevention have been linked to increased bleeding events and no benefit in terms of mortality reduction in older adults.

 

Association of Oral Anticoagulation With Stroke in Atrial Fibrillation or Heart Failure: A Comparative Meta-Analysis

Stroke
Review (21 trials; n=29,198) found the association of oral anticoagulation with all stroke (vs control) was consistent for AF (OR 0.51; 95% CI 0.42–0.63]) and heart failure with reduced ejection fraction (0.61; 0.47–0.79); the relative association with other outcomes was similar.

 

 

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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Predictors, time course, and outcomes of persistence patterns in oral anticoagulation for non-valvular atrial fibrillation: a Dutch Nationwide Cohort Study

European Heart Journal
Study (n=93 048) found at least 25% of pts were non-persistent with oral anticoagulants (OACs) within 4 years, resulting in increased risk of composite of ischaemic stroke (IS) and IS-related death (HR 1.79, 95% CI 1.49–2.15) and IS (1.58; 1.29–1.93) vs persistence with OACs.

 

Frailty and clinical outcomes of direct oral anticoagulants versus warfarin in older adults with atrial fibrillation: A cohort study

Annals of Internal Medicine
In this analysis of Medicare claims data, only apixaban was consistently associated with lower rates of the composite end point of death, ischaemic stroke, and major bleeding than warfarin across all frailty levels (n=218,738; HR, 0.68 [CI, 0.65 to 0.72].

 

Abelacimab for Prevention of Venous Thromboembolism

New England Journal of Medicine
This trial (n=412) found treatment with abelacimab, a monoclonal antibody that binds to factor XI, was linked to a lower rate of VTE occurrence compared to enoxaparin; 13%, 5% and 4% in the 30mg, 75mg and 150mg abelacimab groups vs 22%, respectively (p<0.001).

 

Antithrombotic therapies in aortic and peripheral arterial diseases in 2021: a consensus document from the ESC working group on aorta and peripheral vascular diseases, the ESC working group on thrombosis, and the ESC working group on cardiovascular pharmacotherapy

European Heart Journal
This consensus document provides guidance on antithrombotic therapy according to arterial disease localisations and clinical presentation and highlights that multidisciplinary team discussions are important in patients with uncertain ischaemic/bleeding balance.

 

Standard prophylactic versus intermediate dose enoxaparin in adults with severe COVID-19: A multi-center, open-label, randomized controlled trial

Journal of Thrombosis and Haemastasis
RCT of 176 hospitalized adults with severe COVID-19, found no difference in all-cause mortality at 30 days for standard prophylactic dose and intermediate dose enoxaparin (21% vs 15%; HR, 0.67; 95% CI 0.33–1.37; P = 0.31), or rates of arterial or venous thrombosis.

 

COVID-19 rapid guideline: vaccine-induced immune thrombocytopenia and thrombosis (VITT)- guidance (NG200)

National Institute for Health and Care Excellence
This guideline was produced to support clinicians to diagnose and manage this newly recognised syndrome for which there is limited evidence available to inform clinical management. Identification and management of VITT is evolving quickly as the case definition becomes clearer.

 

Risk assessment models for venous thromboembolism in hospitalised adult patients: a systematic review

BMJ Open
Analysis of 51 studies (24 unique risk assessment models [RAMs]) found estimates for sensitivity and specificity were highly variable; results suggest RAMs have generally weak predictive accuracy for VTE, with insufficient evidence to recommend the use of any particular model.

 

Comparative table of low molecular weight heparins and fondaparinux

Specialist Pharmacy Service
This comparative table of low molecular weight heparins and fondaparinux has been compiled to aid product selection should there be a need to switch product in the event of a shortage.

 

Tinzaparin sodium (10,000 IU/ml) 3,500 units in 0.35ml and 4,500 units in 0.45ml pre-filled syringes - Supply Disruption

Medicines and Healthcare products Regulatory Agency
These pre-filled syringes will be unavailable between middle of October 2021 and January 2022 (date TBC). All other presentations of tinzaparin remain unaffected by this supply disruption. This alert contains further information and action for providers.

 

 

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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Network Meta-Analysis of Ticagrelor for Stroke Prevention in Patients at High Risk for Cardiovascular or Cerebrovascular Events

Stroke
Review (26 RCTs; n= 124 495) found compared to controls, addition of aspirin to ticagrelor reduced risk of ischemic stroke (RR, 0.80; 95% CI, 0.71–0.89 vs 0.88; 0.77–1.00 for ticagrelor monotherapy; P=0.05) but was associated with increased bleeding risk.

 

Trends in the pharmacological management of atrial fibrillation in UK general practice 2008–2018

Heart
There was increase in patients with AF appropriately prescribed anticoagulants (from 45.3 to 71.1%) following NICE and ESC guidelines, which correlates with improvements in mortality and stroke outcomes. Beta-blockers appear increasingly favoured over digoxin for rate control.

 

Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial

JAMA Neurology
Sub-group analysis (n= 9983) ticagrelor plus aspirin showed similar efficacy and safety vs aspirin alone in patients presenting with moderate acute ischemic stroke and those presenting with less severe ischemic cerebrovascular events.

 

Aspirin versus P2Y12 inhibitors with anticoagulation therapy for atrial fibrillation

Heart
Study (n= 1075 of which ~60% on PPI) found no significant differences in CV and bleeding events in patients with AF and stable CAD taking rivaroxaban with P2Y12 inhibitors or aspirin in chronic phase (efficacy HR: 1.31; 95% CI 0.88 to 1.94; safety HR: 0.79; 95% CI 0.43 to 1.47).

 

Inappropriate anticoagulation of patients with a mechanical heart valve

Medicines and Healthcare products Regulatory Agency
This alert asks GPs and other NHS providers of anticoagulation services to identify patients with a record of a mechanical heart valve and receiving a DOAC, and to urgently review these patients to ensure they are on the most appropriate anticoagulation therapy and monitoring.

 

 

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 approves dabigatran etexilate oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism

US Food and Drug Administration
Approval is for oral pellets to treat children age 3 months to <12 years and for capsules to treat patients age ≥8 years, with VTE after parenteral anticoagulation for ≥5 days, and also for prevention of recurrent clots in those who have completed treatment for their first VTE.

 

Comparison of effectiveness and safety between ticagrelor and clopidogrel in patients with acute coronary syndrome and on dialysis in Taiwan

British Journal of Clinical Pharmacology
Study (n=2185) of dialysis patients with ACS found at 12 months, ticagrelor group had higher risk for major adverse CV event (aHR 1.29; 95% CI 1.16–1.44) and also higher risk of major bleeding event vs clopidogrel group (sHR 1.49; 95% CI 1.34–1.65).

 

Pulmonary embolism in patients with COVID-19: incidence, risk factors, clinical characteristics, and outcome

European Heart Journal
Spanish retrospective study identified 368 PE in 74,814 patients with COVID-19 attending A+E (~ 0.5%), the incidence of which is ~ninefold higher than in the general (non-COVID-19) population. It notes that mortality is higher in COVID-19 than in non-COVID-19 patients with PE.

 

Number needed to treat for net effect of anticoagulation in atrial fibrillation: Real-World vs. Clinical Trial Evidence

British Journal of Clinical Pharmacology
Post-hoc analysis demonstrated potential clinical applicability of the NNT for net benefit approach; the Calculator of Absolute Stroke Risk was used to show that the NNTnet of anticoagulation therapy at 1-year was 34 in a real-world cohort and 46 in a clinical trial population.

 

Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention: A Prespecified Subgroup Analysis of a Randomized Clinical Trial

JAMA Cardiology
Analysis (n=3024) found incidence of primary composite end point (all-cause death, MI or stroke) at 12 months occurred less frequently in prasugrel vs. ticagrelor group (120 [7.1%] vs 162 [9.8%], respectively; HR 1.41; 95% CI, 1.11-1.78; p= 0.005); bleeding events were comparable.

 

XIENCE stent receives FDA approval for use of only one-month dual antiplatelet therapy (DAPT) in (HBR) high bleeding risk patients

Biospace Inc.
Patients who receive stents are typically on DAPT for 6 to 12 months but may cause bleeding in HBR patients. According to Abbott, the XIENCE 28 and XIENCE 904 studies showed that DAPT can be safely discontinued early (as short as 28 days) with no increased risk in adverse events.

 

Cerebral Venous Thrombosis

New England Journal of Medicine
This review covers diagnosis, based on clinical and imaging features, and treatments that have become available since the subject was last reviewed, in light of current interest, due to rare cases associated with certain of the Covid-19 vaccines.

 

DTB select: Aspirin and gastrointestinal bleeding risk in older people

Drug and Therapeutics Bulletin
Summary and context is provided for an analysis of data from the ASPREE study, which found the 5-year risk of a gastrointestinal bleed in older people taking low-dose aspirin (100mg) ranged from 0.40% in those aged 70 years to 5% in those aged 80 years with multiple risk factors.

 

 

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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