Warfarin Versus Thrombin Inhibitor ( Dabigatran ) The RE-LY trial ( 9 , 18 ) showed that treatment with dabigatran , 150 mg , is superior to warfarin in reducing the incidence of the composite outcome of stroke or systemic embolism .
No statistically significant difference was observed between the 2 therapies with regard to major bleeding , myocardial infa rct ion , or
Atrial fibrillation ( AF ) is characterized by uncoordinated atrial activation with consequent deterioration of mechanical function ( 1 ) .
It is the most common sustained cardiac arrhythmia , and according to estimates , 12.1 million Americans will have AF by 2050 ( 2 ) .
Patients with AF have increased risk for embolic stroke , heart failure , and cognitive impairment ; reduced quality of life ; and higher overall mortality ( 35 ) .
Strokes related to AF have been characterized as more severe ( 6 , 7 ) and translate to a substantial economic burden , costing Medicare approximately $ 8 billion annually ( 8) .
Antithrombotic therapies are the mainstays for preventing thromboembolic events in patients with AF .
Oral anticoagulation with vitamin K antagonists ( VKAs ) has long been the gold st and ard therapy for stroke prevention in these patients .
However , the challenges of monitoring VKA therapy and the many associated food and drug interactions have fueled the development of novel therapeutic options .
Currently , 4 direct-acting oral anticoagulants ( DOACs ) are approved for stroke prevention in patients with nonvalvular AF : the thrombin inhibitor dabigatran and the factor Xa inhibitors apixaban , rivaroxaban , and edoxaban .
In addition , procedural interventions , such as left atrial appendage ( LAA ) occlusion devices , are an alternative treatment for patients who are at high risk for bleeding while receiving anticoagulation therapy .
This systematic review up date s previous review s ( 13 ) and aims to compare the effectiveness of the available medical and procedural therapies in preventing thromboembolic events and bleeding complications in patients with AF .
Dabigatran versus warfarin in patients with atrial fibrillation.
BACKGROUND Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use . Dabigatran is a new oral direct thrombin inhibitor . METHODS In this noninferiority trial , we r and omly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive , in a blinded fashion , fixed doses of dabigatran--110 mg or 150 mg twice daily -- or , in an unblinded fashion , adjusted-dose warfarin . The median duration of the follow-up period was 2.0 years . The primary outcome was stroke or systemic embolism . RESULTS Rates of the primary outcome were 1.69 % per year in the warfarin group , as compared with 1.53 % per year in the group that received 110 mg of dabigatran ( relative risk with dabigatran , 0.91 ; 95 % confidence interval [ CI ] , 0.74 to 1.11 ; P<0.001 for noninferiority ) and 1.11 % per year in the group that received 150 mg of dabigatran ( relative risk , 0.66 ; 95 % CI , 0.53 to 0.82 ; P<0.001 for superiority ) . The rate of major bleeding was 3.36 % per year in the warfarin group , as compared with 2.71 % per year in the group receiving 110 mg of dabigatran ( P=0.003 ) and 3.11 % per year in the group receiving 150 mg of dabigatran ( P=0.31 ) . The rate of hemorrhagic stroke was 0.38 % per year in the warfarin group , as compared with 0.12 % per year with 110 mg of dabigatran ( P<0.001 ) and 0.10 % per year with 150 mg of dabigatran ( P<0.001 ) . The mortality rate was 4.13 % per year in the warfarin group , as compared with 3.75 % per year with 110 mg of dabigatran ( P=0.13 ) and 3.64 % per year with 150 mg of dabigatran ( P=0.051 ) . CONCLUSIONS In patients with atrial fibrillation , dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin , as well as lower rates of major hemorrhage .  Dabigatran administered at a dose of 150 mg , as compared with warfarin , was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage . ( Clinical Trials.gov number , NCT00262600 .
Warfarin Versus Thrombin Inhibitor ( Dabigatran ) The RE-LY trial ( 9 , 18 ) showed that treatment with dabigatran , 150 mg , is superior to warfarin in reducing the incidence of the composite outcome of stroke or systemic embolism .
No statistically significant difference was observed between the 2 therapies with regard to major bleeding , myocardial infa rct ion , or
Atrial fibrillation ( AF ) is characterized by uncoordinated atrial activation with consequent deterioration of mechanical function ( 1 ) .
It is the most common sustained cardiac arrhythmia , and according to estimates , 12.1 million Americans will have AF by 2050 ( 2 ) .
Patients with AF have increased risk for embolic stroke , heart failure , and cognitive impairment ; reduced quality of life ; and higher overall mortality ( 35 ) .
Strokes related to AF have been characterized as more severe ( 6 , 7 ) and translate to a substantial economic burden , costing Medicare approximately $ 8 billion annually ( 8) .
Antithrombotic therapies are the mainstays for preventing thromboembolic events in patients with AF .
Oral anticoagulation with vitamin K antagonists ( VKAs ) has long been the gold st and ard therapy for stroke prevention in these patients .
However , the challenges of monitoring VKA therapy and the many associated food and drug interactions have fueled the development of novel therapeutic options .
Currently , 4 direct-acting oral anticoagulants ( DOACs ) are approved for stroke prevention in patients with nonvalvular AF : the thrombin inhibitor dabigatran and the factor Xa inhibitors apixaban , rivaroxaban , and edoxaban .
In addition , procedural interventions , such as left atrial appendage ( LAA ) occlusion devices , are an alternative treatment for patients who are at high risk for bleeding while receiving anticoagulation therapy .
This systematic review up date s previous review s ( 13 ) and aims to compare the effectiveness of the available medical and procedural therapies in preventing thromboembolic events and bleeding complications in patients with AF .