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ENGAGE AF-TIMI 48 trial: transition of patients from blinded study drug to open-label anticoagulation


At the end of two previous trials, an excess of stroke and bleeding was observed in patients with atrial fibrillation randomized to a new oral anticoagulant ( NOAC ) who transitioned to a vitamin K antagonist ( VKA ).

The ENGAGE AF-TIMI 48 ( Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 ) trial compared once-daily Edoxaban ( Lixiana ) to Warfarin ( Coumadin ) for stroke prevention in patients with atrial fibrillation.
An end-of-trial transition plan was developed to minimize the risks of stroke due to inadequate anticoagulation and bleeding from excessive anticoagulation during this critical period.

All patients on the blinded study drug at the trial's conclusion were included in this analysis. In pre-specified analyses, stroke, bleeding, and death that occurred through 30 days after the end-of-trial visit were stratified by randomized treatment allocation and open-label anticoagulant selected post-trial.

Of the 13,642 patients taking the blinded study drug at the end of the trial, 9,304 ( 68.2% ) were transitioned to open-label VKA and 4,258 patients ( 31.2% ) to an NOAC.

There were 21 strokes evenly distributed across the 3 randomized treatment arms: Warfarin 7 ( 1.90%/year ), Edoxaban high dose 7 ( 1.89%/year ), Edoxaban low dose 7 ( 1.85%/year ).

Major bleeding was also similar across the three treatment arms: Warfarin 11 ( 2.98%/year ), Edoxaban high dose 10 ( 2.69%/year ), Edoxaban low dose 18 ( 4.76%/year ).

In patients transitioned to VKA, 85% of patients had at least 1 INR greater than or equal to 2 by day 14 after the transition and 99% by day 30.

In conclusion, the ENGAGE AF-TIMI 48 transition plan protected patients from an excess of thrombotic and bleeding events and should be helpful in clinical practice when patients are transitioned between oral anticoagulants. ( Xagena )

Ruff CT et al, J Am Coll Cardiol 2014;64:576-584

XagenaMedicine_2014



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