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 .
Efficacy and Safety of Dabigatran Compared With Warfarin in Relation to Baseline Renal Function in Patients With Atrial Fibrillation: A RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) Trial Analysis
Background — Renal impairment increases the risk of stroke and bleeding in patients with atrial fibrillation . In the R and omized Evaluation of Long-Term Anticoagulant Therapy ( RELY ) trial , dabigatran , with ≈80 % renal elimination , displayed superiority over warfarin for prevention of stroke and systemic embolism in the 150-mg dose and significantly less major bleeding in the 110-mg dose in 18 113 patients with nonvalvular atrial fibrillation . This prespecified study investigated these outcomes in relation to renal function . Methods and Results — Glomerular filtration rate was estimated with the Cockcroft-Gault , Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) , and Modification of Diet in Renal Disease ( MDRD ) equations in all r and omized patients with available creatinine at baseline ( n=17 951 ) , and cystatin C – based glomerular filtration rate was estimated in a sub population with measurements available ( n=6190 ) . A glomerular filtration rate ≥80 , 50 to < 80 , and < 50 mL/min was estimated in 32.6 % , 47.6 % , and 19.8 % and in 21.6 % , 59.6 % , and 18.8 % of patients based on Cockcroft-Gault and CKD-EPI , respectively . Rates of stroke or systemic embolism , major bleeding , and all-cause mortality increased as renal function decreased . The rates of stroke or systemic embolism were lower with dabigatran 150 mg and similar with 110 mg twice daily compared with warfarin , without significant heterogeneity in subgroups defined by renal function ( interaction P>0.1 for all ) . For the outcome of major bleeding , there were significant interactions between treatment and renal function according to CKD-EPI and MDRD equations , respectively ( P<0.05 ) . The relative reduction in major bleeding with either dabigatran dose compared with warfarin was greater in patients with glomerular filtration rate ≥80 mL/min . Conclusions — The efficacy of both dosages of dabigatran was consistent with the overall trial irrespective of renal function . However , with the CKD-EPI and MDRD equations , both dabigatran dosages displayed significantly lower rates of major bleeding in patients with glomerular filtration rate ≥80 mL/min . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : 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 .