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Efficacy and safety of novel anticoagulants compared with established agents.

ABSTRACT: Dabigatran, rivaroxaban, and apixaban are novel oral anticoagulants that offer major advantages over existing agents. The onset of the anticoagulant effect of these agents is rapid. Each agent has a predictable anticoagulant response that eliminates the need for monitoring. Clinical trials have been completed with all three agents in the prevention and treatment of the three leading causes of cardiovascular death: myocardial infarction, stroke, and venous thromboembolism (VTE). Novel agents have shown reduced or similar rates of thrombosis, major bleeding, and adverse events when weighed against either low molecular weight heparin or warfarin. Additional trials are underway and more agents are in development. As a result, novel anticoagulants may impact physician prescribing practices and warrant consideration in patients requiring thrombosis management.

SUBMITTER: Rybak I

PROVIDER: S-EPMC3573404 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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Efficacy and safety of novel anticoagulants compared with established agents.

Rybak Iwona I Ehle Michael M Buckley Leo L Fanikos John J

Therapeutic advances in hematology 20110601 3

Dabigatran, rivaroxaban, and apixaban are novel oral anticoagulants that offer major advantages over existing agents. The onset of the anticoagulant effect of these agents is rapid. Each agent has a predictable anticoagulant response that eliminates the need for monitoring. Clinical trials have been completed with all three agents in the prevention and treatment of the three leading causes of cardiovascular death: myocardial infarction, stroke, and venous thromboembolism (VTE). Novel agents have ...[more]

PMID: 23556088

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Project description:IntroductionNovel oral anticoagulants (NOACs) have been approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). A large number of patients are on NOACs when they present for AF ablation. We intended to evaluate the safety and efficacy of NOACs for AF ablation during the periprocedural period by performing a meta-analysis of trials comparing NOACs with warfarin.MethodsStudies comparing NOACs (dabigatran and rivaroxaban) with warfarin as periprocedural anticoagulants for AF ablation were identified using an electronic search. Primary outcomes were: (1) a composite endpoint of stroke, transient ischemic attack (TIA), peripheral arterial embolism, or silent cerebral lesions on magnetic resonance imaging (MRI) and (2) major bleeding complications. A random effects model was used to pool the safety and efficacy data across all included trials.ResultsWhen compared to warfarin, there was an increased risk of the composite endpoint of stroke, TIA, peripheral arterial embolism, or silent cerebral lesions on MRI with NOACs as periprocedural anticoagulants for AF ablation [odds ratio (OR): 1.69, 95% confidence interval (CI): 1.06-2.68]. Sub-group analysis revealed a higher risk of composite endpoint with dabigatran as a periprocedural anticoagulant for AF ablation (OR: 2.01, 95% CI: 1.19-3.39) whereas the risk was similar with rivaroxaban (OR: 0.90, 95% CI: 0.34-2.41). Sensitivity analysis after excluding silent cerebral lesions on MRI showed there was no increased risk of thromboembolic events with either dabigatran (OR: 1.69, 95% CI: 0.81-3.51) or rivaroxaban (OR: 0.70, 95% CI: 0.12-4.04). Risk of bleeding with NOACs was similar to warfarin (OR: 0.91, 95% CI: 0.62-1.34).ConclusionNOACs are comparable to warfarin in terms of bleeding complications. However, dabigatran therapy is potentially associated with a higher risk of silent cerebral lesions on MRI. The results of this study should be considered as hypothesis-generating and assessed further in prospective randomized clinical studies.

Project description:We examined a large community-based sample of patients with atrial fibrillation (AF) and valvular heart disease (VHD) (excluding prosthetic valves) with a goal to compare outcomes among patients with AF, with and without VHD, taking warfarin, dabigatran, and rivaroxaban.We identified Medicare beneficiaries enrolled in Medicare Part D benefit plan from 2011 to 2013 with newly diagnosed AF (18 137 patients with VHD [dabigatran, 1979; rivaroxaban, 2027; warfarin, 14 131] and 85 596 patients without VHD [dabigatran, 13 522; rivaroxaban, 14 257; warfarin, 57 817]). Primary outcomes of all-cause mortality, ischemic strokes, major bleeding, and myocardial infarction were compared across the 3 anticoagulants using 3-way propensity-matched samples. After propensity matching, a total of 5871 patients with VHD and 40 221 patients without VHD and AF were studied. Both dabigatran and rivaroxaban were associated with significantly lower risk of death in patients with VHD with AF (dabigatran versus warfarin: hazard ratio, 0.71; 95% confidence interval, 0.52-0.98; P=0.038; rivaroxaban versus warfarin: hazard ratio, 0.68; 95% confidence interval, 0.49-0.95; P=0.022). Nongastrointestinal bleeding was significantly reduced with dabigatran and rivaroxaban versus warfarin in those with VHD (dabigatran versus warfarin: hazard ratio, 0.17; 95% confidence interval, 0.06-0.49; P=0.001; rivaroxaban versus warfarin: hazard ratio, 0.37; 95% confidence interval, 0.17-0.84; P=0.017). Ischemic stroke and gastrointestinal bleeding rates did not differ between rivaroxaban, dabigatran, and warfarin in patients with VHD. The effects of the 3 anticoagulants on outcomes were comparable in patients with and without VHD and with AF.In this cohort of Medicare beneficiaries with VHD (excluding patients with prosthetic valves) and new-onset AF between 2011 and 2013, novel oral non-vitamin K anticoagulants were safe and effective options for prevention of systemic thromboembolism.

Project description:Dabigatran, an oral thrombin inhibitor, and rivaroxaban and apixaban, oral factor Xa inhibitors, have been found to be safe and effective in reducing stroke risk in patients with atrial fibrillation. We sought to compare the efficacy and safety of the 3 new agents based on data from their published warfarin-controlled randomized trials, using the method of adjusted indirect comparisons.We included findings from 44 535 patients enrolled in 3 trials of the efficacy of dabigatran (Randomized Evaluation of Long-Term Anticoagulation Therapy [RELY]), apixaban (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation [ARISTOTLE]), and rivaroxaban (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation [ROCKET-AF]), each compared with warfarin. The primary efficacy end point was stroke or systemic embolism; the safety end point we studied was major hemorrhage. To address a lack of comparability between trial populations caused by the restriction of ROCKET-AF to high-risk patients, we conducted a subgroup analysis in patients with a CHADS(2) score ?3. We found no statistically significant efficacy differences among the 3 drugs, although apixaban and dabigatran were numerically superior to rivaroxaban. Apixaban produced significantly fewer major hemorrhages than dabigatran and rivaroxaban.An indirect comparison of new anticoagulants based on existing trial data indicates that in patients with a CHADS(2) score ?3 dabigatran 150 mg, apixaban 5 mg, and rivaroxaban 20 mg resulted in statistically similar rates of stroke and systemic embolism, but apixaban had a lower risk of major hemorrhage compared with dabigatran and rivaroxaban. Until head-to-head trials or large-scale observational studies that reflect routine use of these agents are available, such adjusted indirect comparisons based on trial data are one tool to guide initial therapeutic choices.

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Efficacy and safety of novel anticoagulants compared with established agents.

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Efficacy and safety of novel anticoagulants compared with established agents.

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