ENGAGE AF-TIMI 48: Endoxaban versus warfarin in atrial fibrillation

The endoxaban is an oral direct inhibitor of factor Xa with a rapid onset of action and a half-life of 8-10 hours. Endoxaban efficacy and safety for long-term versus warfarinin patients with atrial fibrillation was not studied. This was a randomized, double-blind study that compares two different regimes of endoxaban with warfarin in 21105 patients with moderate/high risk atrial fibrillation.

The primary efficacy end point was the incidence of stroke or systemic embolism and the safety major bleeding. Randomization was 1:1:1 to warfarin (adjusted the dose to obtain a RIN between 2 and 3), endoxaban high doses (60 mg) or endoxaban low dose (30 mg). The annual rate of the primary end point was 1.5 % for warfarin versus 1.18 % for endoxaban high doses (p < 0.001 for noninferiority) versus 1.61 % for endoxaban low doses (p = 0.005 for non-inferiority). The annual rate of major bleeding was 3.4 % with warfarin versus 2.75 % for endoxaban high doses ( p < 0.001 ) versus 1.61 % low doses ( p < 0.001) .

Conclusion: 

Both schemes of endoxaban daily doses were not inferior to warfarin in regards to the prevention of stroke and systemic embolism, but with lower rates of bleeding and death for cardiovascular causes.

Article

3_robert_giugliano_slides
Robert P. Giugliano
2013-11-19

Original title: ENGAGE AF-TIMI 48 Primary Results

More articles by this author

COAG Trial: Dose of warfarin and Pharmacogenetics

Observational studies identified two genes that influence the dose of warfarin (CYP2C9 and VKORC1). The clinical utility of dose adjustment by genetics has been...

ERASE: Endovascular treatment plus exercise versus exercise alone to treat claudication

Initial therapy for intermittent claudication has been historically the gear train, however, especially in recent years; the number of peripheral angioplasties has increased, proving...

RADAR AF: High-frequency ablation versus pulmonary vein isolation to treat atrial fibrillation

Atrial fibrillation is initiated by focal triggers and maintained by an atrial substrate called fractioned complex of atrial electrograms. Isolating the pulmonary veins (triggers)...

EU-PACT: Warfarin dose guided by genotype

Anticoagulation level in response to a fixed dose of warfarin is difficult to predict at the start of therapy. The CYP2C9 gene polymorphism (involved...

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

Evolution of Small Balloon-Expandable Valves

Small aortic rings (20 mm) have posed a significant challenge for both surgery and transcatheter aortic valve implantation (TAVI) due to their association with an...

TCT 2024 | Asymptomatic Severe Aortic Stenosis: What Should Be our Approach?

Approximately 3% of the population over 65 years old has aortic stenosis. Current guidelines recommend valve replacement for patients with symptoms or an ejection...

TCT 2024 | FAVOR III EUROPA

The study FAVOR III EUROPA, a randomized trial, included 2,000 patients with chronic coronary syndrome, or stabilized acute coronary syndrome, and intermediate lesions. 1,008...