Conference report: Updated results from ongoing phase III RE-VERSE AD study on safety and efficacy of idarucizumab (Praxbind) in urgent situations

Biospace Inc.

In trial of 494 patients who had uncontrolled or life-threatening bleeding or required emergency surgery or an invasive procedure, primary endpoint of reversal of anticoagulant effect of dabigatran with 5g of idarucizumab within 4 hours was 100% Reversal was evident immediately.

Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy

Circulation

Study (n=2124) found either rivaroxaban 15 mg OD+P2Y12 inhibitor monotherapy or 2.5 mg rivaroxaban BD plus dual antiplatelet therapy (DAPT) was associated with a reduced risk of all-cause mortality/recurrent hospitalisation vs standard-of-care vitamin k antagonist+DAPT.

Warfarin utilisation and anticoagulation control in patients with atrial fibrillation and chronic kidney disease

Heart

Study (n=123188) found warfarin use decreased with increasing severity of chronic kidney disease (CKD) (57.2%–46.4%), but was higher in patients on dialysis (62.3%). Proportion of patients with time in range (TIR) ≥60% decreased with CKD severity; 21% on dialysis achieved TIR≥60%.

Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI

New England Journal of Medicine

The administration of either low-dose rivaroxaban (R)+P2Y12 inhibitor for 12 months or very-low-dose R+DAPT for 1, 6, or 12 months was associated with a
lower rate of clinically significant bleeding than was standard therapy with a vit K antagonist+DAPT for 1, 6, or 12 months.

Under-prescribing of Prevention Drugs and Primary Prevention of Stroke and Transient Ischaemic Attack in UK General Practice: A Retrospective Analysis

PLOS Medicine

UK study (n=29043) found >50% of people eligible for lipid-lowering, anticoagulant, or antihypertensive drugs were not prescribed them prior to first stroke/TIA. The authors estimate that around 12000 first strokes could be prevented/year annually through optimal prescribing.

Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban)

Circulation

This study (n=7513) reports that there were fewer all-cause strokes (0.54% v 0.97%; RR=0.56; P=0.032) and ischaemic strokes (0.48% v 0.91%; RR=0.53; P=0.026) among patients treated with betrixaban v enoxaparin through 77 days of follow-up.

Trade-off of myocardial infarction vs. bleeding types on mortality after acute coronary syndrome: lessons from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) randomized trial

European Heart Journal

Analysis of the TRACER trial (n=12,944) found that MI was associated with a greater risk of mortality compared with Bleeding Academic Research Consortium (BARC) 2 and 3a bleeding; a similar risk of mortality to BARC 3c bleeding; and a lower risk of mortality than BARC 3c bleeding.

Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease

New England Journal of Medicine

RCT (n=13,885) found that ticagrelor is not superior to clopidogrel for reducing cardiovascular events (10.8% vs 10.6%, HR 1.02, 95% CI 0.92-1.13). Major
bleeding occurred at similar rates (1.6% in both groups, HR 1.10, 95% CI 0.84-1.43).

CHMP issues positive opinion for lonoctocog alfa (Afstyla) for treatment and prophylaxis of bleeding in patients with haemophilia A

European Medicines Agency

Lonoctocog alfa is a single-chain recombinant human factor VIII product. It is proposed that the market authorisation extends to use in all age groups.

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