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 .
Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation.
Importance Dabigatran and rivaroxaban are non-vitamin K oral anticoagulants approved for stroke prevention in patients with nonvalvular atrial fibrillation ( AF ) . There are no r and omized head-to-head comparisons of these drugs for stroke , bleeding , or mortality outcomes . Objective To compare risks of thromboembolic stroke , intracranial hemorrhage ( ICH ) , major extracranial bleeding including major gastrointestinal bleeding , and mortality in patients with nonvalvular AF who initiated dabigatran or rivaroxaban treatment for stroke prevention . Design , Setting , and Participants Retrospective new-user cohort study of 118 891 patients with nonvalvular AF who were 65 years or older , enrolled in fee-for-service Medicare , and who initiated treatment with dabigatran or rivaroxaban from November 4 , 2011 , through June 30 , 2014 . Differences in baseline characteristics were adjusted using stabilized inverse probability of treatment weights based on propensity scores . The data analysis was performed from May 7 , 2015 , through June 30 , 2016 . Exposures Dabigatran , 150 mg , twice daily ; rivaroxaban , 20 mg , once daily . Main Outcomes and Measures Adjusted hazard ratios ( HRs ) for the primary outcomes of thromboembolic stroke , ICH , major extracranial bleeding including major gastrointestinal bleeding , and mortality , with dabigatran as reference . Adjusted incidence rate differences ( AIRDs ) were also estimated . Results A total of 52 240 dabigatran-treated and 66 651  rivaroxaban-treated patients ( 47 % female ) contributed 15 524 and 20 199 person-years of on-treatment follow-up , respectively , during which 2537 primary outcome events occurred . Rivaroxaban use was associated with a statistically nonsignificant reduction in thromboembolic stroke ( HR , 0.81 ; 95 % CI , 0.65 - 1.01 ; P = .07 ; AIRD = 1.8 fewer cases/1000 person-years ) , statistically significant increases in ICH ( HR , 1.65 ; 95 % CI , 1.20 - 2.26 ; P = .002 ; AIRD = 2.3 excess cases/1000 person-years ) and major extracranial bleeding ( HR , 1.48 ; 95 % CI , 1.32 - 1.67 ; P < .001 ; AIRD = 13.0 excess cases/1000 person-years ) , including major gastrointestinal bleeding ( HR , 1.40 ; 95 % CI , 1.23 - 1.59 ; P < .001 ; AIRD = 9.4 excess cases/1000 person-years ) , and with a statistically nonsignificant increase in mortality ( HR , 1.15 ; 95 % CI , 1.00 - 1.32 ; P = .051 ; AIRD = 3.1 excess cases/1000 person-years ) . In patients 75 years or older or with CHADS2 score greater than 2 , rivaroxaban use was associated with significantly increased mortality compared with dabigatran use . The excess rate of ICH with rivaroxaban use exceeded its reduced rate of thromboembolic stroke . Conclusions and Relevance Treatment with rivaroxaban 20 mg once daily was associated with statistically significant increases in ICH and major extracranial bleeding , including major gastrointestinal bleeding , compared with dabigatran 150 mg twice daily
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 .