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 .
Economic Analysis of Apixaban Therapy for Patients With Atrial Fibrillation From a US Perspective: Results From the ARISTOTLE Randomized Clinical Trial
Importance The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial reported that apixaban therapy was superior to warfarin therapy in preventing stroke and all-cause death while causing significantly fewer major bleeds . To establish the value proposition of substituting apixiban therapy for warfarin therapy in patients with atrial fibrillation , we performed a cost-effectiveness analysis using patient-level data from the ARISTOTLE trial . Objective To assess the cost and cost-effectiveness of apixaban therapy compared with warfarin therapy in patients with atrial fibrillation from the perspective of the US health care system . Design , Setting , and Participants This economic analysis uses patient-level re source use and clinical data collected in the ARISTOTLE trial , a multinational r and omized clinical trial that observed 18 201 patients ( 3417 US patients ) for a median of 1.8 years between 2006 and 2011 . Interventions Apixaban therapy vs warfarin therapy . Main Outcomes and Measures Within-trial re source use and cost were compared between treatments , using externally derived US cost weights . Life expectancies for US patients were estimated according to their baseline risk and treatment using time-based and age-based survival models developed using the overall ARISTOTLE population . Quality -of-life adjustment factors were obtained from external sources . Cost-effectiveness ( incremental cost per quality -adjusted life-year gained ) was evaluated from a US perspective , and extensive sensitivity analyses were performed . Results Of the 3417 US patients enrolled in ARISTOTLE , the mean ( SD ) age was 71 ( 10 ) years ; 2329 ( 68.2 % ) were male and 3264 ( 95.5 % ) were white . After 2 years of anticoagulation therapy , health care costs ( excluding the study drug ) of patients treated with apixaban therapy and warfarin therapy were not statistically different ( difference , −$60 ; 95 % CI , −$2728 to $ 2608 ) . Life expectancy , modeled from ARISTOTLE outcomes , was significantly longer with apixaban therapy vs warfarin therapy ( 7.94 vs 7.54 quality -adjusted life years ) . The incremental cost , including cost of anticoagulant and monitoring , of achieving these benefits was within accepted US norms ( $ 53 925 per quality -adjusted life year , with 98 % likelihood of meeting a $ 100 000 willingness-to-pay threshold ) . Results were generally consistent when model assumptions were varied , with lifetime cost-effectiveness most affected by the price of apixaban and the time horizon . Conclusions and Relevance Apixaban therapy for ARISTOTLE-eligible patients with atrial fibrillation provides clinical benefits at an incremental cost that represents reasonable value for money judged using US benchmarks for cost-effectiveness . Trial Registration clinical trials.gov Identifier :
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 .