Items filtered by date: August 2021

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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