Friday, 30 June 2017 20:54

Anticoagulation news items. Week commencing 26th June 2017

Low-Molecular-Weight Heparin and the Relative Risk of Surgical Site Bleeding Complications: Results of a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Venous Thromboprophylaxis in Patients After Total Joint Arthroplasty

Journal of Arthroplasty

Review of 45 RCTs (n= 56,730) found low-molecular-weight heparin had increased relative risk (RR) of surgical site bleeding vs. control (2.32; 95% CI, 1.40-3.85), warfarin (1.54; 1.23-1.94), and dabigatran (4.38; 1.53-12.57). There was trend towards increased risk vs. apixaban.

 

U.S. FDA grants priority review of rivaroxaban supplemental new drug application for 10 mg dose to reduce risk of recurrent venous thromboembolism (VTE)

Biospace Inc.

Application is for use of 10 mg once-daily dose to reduce risk of VTE after ≥6 months of standard anticoagulation and is based on data from EINSTEIN CHOICE study which found 2 doses of rivaroxaban (10 mg and 20 mg) to be superior to aspirin in reducing risk of recurrent VTE.

 

Risk for Major Bleeding in Patients Receiving Ticagrelor Compared with Aspirin After TIA or Acute Ischemic Stroke in the SOCRATES Study

Circulation

Review of the SOCRATES study found that bleeds occurred in 0.5% of patients on ticagrelor and 0.6% of patients on aspirin (HR 0.83 95% CI 0.52 to 1.34). Intracranial haemorrhage was reported in 0.2% of patients on ticagrelor and 0.3% on aspirin.

 

Benefits and Risks of Antithrombotic Therapy in Essential Thrombocythemia: A Systematic Review

Annals of Internal Medicine

No RCTs were identified. Review of 24 observational studies (n=6153) noted no extractable data on anticoagulants, lack of uniform bleeding definitions, and systematic reporting of outcomes, thus risk–benefit ratio of antiplatelets in essential thrombocythemia is highly uncertain.

 

Conference report- Assessing the risk-benefit of anticoagulants in elderly patients with cancer-associated venous thromboembolism: a population based study

Biospace Inc.

Population-based retrospective cohort study found use of anticoagulants in patients ≥65 years with cancer-related thrombosis results in higher mortality if they develop major bleeding (MB) compared to venous thromboembolic event [VTE] (7-day mortality rate:0.5% VTE vs. 11% MB).

 

Conference report: Emicizumab showed positive results in phase III studies (HAVEN 1 and HAVEN 2) in haemophilia A with inhibitors

Biospace Inc.

HAVEN 1 showed statistically significant reduction in bleed rate of 87% (risk rate 0.13, p<0.0001) with emicizumab prophylaxis vs. on-demand treatment with bypassing agents. HAVEN 2 study noted after 12 weeks, 1 of 19 children on emicizumab reported a treated bleed.

 

FDA approves betrixiban (BevyxXa) for preventing blood clots in hospitalised patients

PharmaTimes

The US approval was based on findings of the APEX Study (n=7513), which found that betrixiban reduced incidence of DVT and PE vs enoxaparin (4.4% vs 6.0%) with no significant increase in major bleeding (0.67% vs. 0.57%).

 

 

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