Saturday, 22 November 2014 17:33

Anticoagulation news items. Week commencing 17th November 2014

CHMP issues positive opinion on licensing of vorapaxar (Zontivity) in EU

European Medicines Agency

Vorapaxar 2mg film tablet is intended for the reduction of atherothrombotic events in adult patients with a history of MI and should be co-administered with aspirin, and where appropriate, with clopidogrel.


Six-month versus 24-month dual antiplatelet therapy after implantation of drug eluting stents in patients non-resistant to aspirin: ITALIC, a randomized multicenter trial

Journal of the American College of Cardiology

This RCT, terminated early due to recruitment problems (n=2031 of planned 2475) found rates of bleeding and of thrombotic events were not significantly different for 6- vs. 24-month dual antiplatelet therapy after PCI with new-generation DES in aspirin responders.


Percutaneous Left Atrial Appendage Closure vs Warfarin for Atrial Fibrillation: A Randomized Clinical Trial

Journal of the American Medical Association

This study found mechanical left atrial appendage closure to be non-inferior and superior to warfarin in patients with nonvalvular AF and CHADS2 score ≥1 in preventing the combined outcome of stroke, systemic embolism and CV death (rate of 2.3 v 3.8 events per 100 patient-years).


Interim data on dabigatran versus warfarin for AF in routine care

Biospace Inc.

An interim analysis of two health insurance databases show that patients with non-valvular AF treated with dabigatran had a lower rate of major haemorrhage (354 v 395 events; HR 0.75) and stroke (62 v 69; HR 0.77, not statistically significant) vs. those receiving warfarin.


Ponatinib (Iclusig▼): risk of vascular occlusive events

Medicines and Healthcare products Regulatory Agency

An EU review on the risk of serious vascular occlusive events with ponatinib has been completed. The available evidence shows that the risk is likely to be dose-dependent; however the data are insufficient to recommend reducing the ponatinib dose.


Relation of Nonsteroidal Anti-inflammatory Drugs to Serious Bleeding and Thromboembolism Risk in Patients With Atrial Fibrillation Receiving Antithrombotic Therapy: A Nationwide Cohort Study

Annals of Internal Medicine

In patients with AF receiving anticoagulants, exposure to NSAIDs increased the risk of serious bleeding (additional 1.9 events per 1000 patients). The majority of events (38.7%) were gastrointestinal; 18.9% were intracranial. Thromboembolism risk was also increased.


Edoxaban Effects on Bleeding Following Punch Biopsy and Reversal by a 4-Factor Prothrombin Complex Concentrate


In this randomised, placebo-controlled Phase 1 study (n=110), a 4-factor prothrombin complex concentrate reversed the effects of edoxaban on bleeding duration following punch biopsy in a dose-dependent manner, with complete reversal observed following 50 IU/kg.


Effects of Golden Hour Thrombolysis: A Prehospital Acute Neurological Treatment and Optimization of Medical Care in Stroke (PHANTOM-S) Substudy

JAMA Neurology

The availability of a stroke emergency mobile unit increased rates of thrombolysis overall (32.6% v 22% with conventional care; P<0.001) and the rates delivered within the first 'golden hour' after symptom onset (31.0% v 4.9%; P<0.01). Short-term mortality rates were similar.

Controversies in cardiovascular medicine – pre-treatment with P2Y12 inhibitors in NSTEMI


Two linked articles discuss whether pre-treatment with P2Y12 inhibitors in Non–ST-segment–elevation acute coronary syndrome is clinically justified.


Extended duration dual antiplatelet therapy and mortality: a systematic review and meta-analysis

The Lancet

This analysis of 14 trials that randomised participants to different durations of dual antiplatelet therapy (DAPT) did not find any difference in all-cause, cardiovascular (CV) or non-CV mortality between extended duration and short-duration DAPT (≤6 months) or aspirin alone.


Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents

New England Journal of Medicine

Patients with a drug-eluting stent who continued dual antiplatelet therapy >1 year had a lower risk of stent thrombosis and major adverse cardiovascular and cerebrovascular events, but increased all-cause mortality (secondary endpoint; HR 1.36; 95% CI, 1.00 to 1.85; P=0.05).



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: