EFFECTIVENESS AND SAFETY OF APIXABAN AND RIVAROXABAN VERSUS WARFARIN FOR THE SECONDARY PREVENTION OF STROKE OR SYSTEMIC EMBOLISM AMONG NONVALVULAR ATRIAL FIBRILLATION PATIENTS

Background and Purpose— We aimed to compare outcomes of ischemic stroke patients with nonvalvular atrial fibrillation between earlier and later initiation of direct oral anticoagulants (DOACs) after stroke onset. Methods— From data for 1192 nonvalvular atrial fibrillation patients with acute ischemic stroke or transient ischemic attack in a prospective, multicenter, observational study, patients who started DOACs during acute hospitalization were included and divided into 2 groups according to a median day of DOAC initiation after onset. Outcomes included stroke or systemic embolism, major bleeding, and death at 3 months, as well as those at 2 years. Results— DOACs were initiated during acute hospitalization in 499 patients in median 4 (interquartile range, 2–7) days after onset. Thus, 223 patients (median age, 74 [interquartile range, 68–81] years; 78 women) were assigned to the early group (≤3 days) and 276 patients (median age, 75 [interquartile range, 69–82] years; 101 women) to the late (≥4 days) group. The early group had lower baseline National Institutes of Health Stroke Scale score and smaller infarcts than the late group. The rate at which DOAC administration persisted at 2 years was 85.2% overall, excluding patients who died or were lost to follow-up. Multivariable Cox shared frailty models showed comparable hazards between the groups at 2 years for stroke or systemic embolism (hazard ratio, 0.86 [95% CI, 0.47–1.57]), major bleeding (hazard ratio, 1.39 [95% CI, 0.42–4.60]), and death (hazard ratio, 0.61 [95% CI, 0.28–1.33]). Outcome risks at 3 months also did not significantly differ between the groups. Conclusions— Risks for events including stroke or systemic embolism, major bleeding, and death were comparable whether DOACs were started within 3 days or from 4 days or more after the onset of nonvalvular atrial fibrillation–associated ischemic stroke or transient ischemic attack. Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT01581502.

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Apixaban in the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation

Drugs of Today ◽

10.1358/dot.2013.49.7.1980498 ◽

2013 ◽

Vol 49 (7) ◽

pp. 425 ◽

Cited By ~ 3

Author(s):

L. Pujadas-Mestres ◽

G. Escolar ◽

E. Arellano-Rodrigo ◽

A.M. Galán

Keyword(s):

Atrial Fibrillation ◽

Systemic Embolism ◽

Nonvalvular Atrial Fibrillation

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Approved Uses of Dabigatran Etexilate as an Anticoagulant

Journal of Pharmacy Technology ◽

10.1177/875512251102700604 ◽

2011 ◽

Vol 27 (6) ◽

pp. 258-265

Author(s):

Joshua B Darnell ◽

Erika L Kleppinger

Keyword(s):

Atrial Fibrillation ◽

Data Extraction ◽

Dabigatran Etexilate ◽

Anticoagulation Therapy ◽

Minor Bleeding ◽

Systemic Embolism ◽

Nonvalvular Atrial Fibrillation ◽

Phase 3 ◽

Study Selection ◽

Life Threatening

Objective: To review, analyze, and critique dabigatran etexilate's approved uses as an anticoagulant. Data Sources: Literature searches were performed via MEDLINE, International Pharmaceutical Abstracts, and Google Scholar through February 2011, using the term dabigatran. Additional data were obtained from tertiary sources and prescribing information. Study Selection and Data Extraction: All published Phase 3 anticoagulation trials investigating dabigatran for currently approved indications were selected. Information from other anticoagulation trials investigating dabigatran was used for critiquing Phase 3 studies. Data Synthesis: Dabigatran etexilate has been evaluated in multiple clinical trials as an alternative to enoxaparin for prevention of venous thromboembolism in total hip and knee replacement surgeries. It has also been evaluated as an alternative to warfarin in stroke and systemic embolism prevention in patients with atrial fibrillation. Results have generally been positive, with few exceptions. The standard adult dose of dabigatran 150 mg twice daily, approved for use in the US for stroke prevention in nonvalvular atrial fibrillation, was found to be superior to warfarin in regard to occurrence rates of stroke or systemic embolism and hemorrhagic stroke. The occurrence rates of intracranial bleeding, life-threatening bleeding, and major or minor bleeding were lower with dabigatran 150 mg twice daily than with warfarin; however, the occurrence of gastrointestinal bleeding was significantly higher. Conclusions: With its numerous benefits, and despite its drawbacks, dabigatran remains a promising option for oral anticoagulation therapy.

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Neurosurgical complications of direct thrombin inhibitors—catastrophic hemorrhage after mild traumatic brain injury in a patient receiving dabigatran

Journal of Neurosurgery ◽

10.3171/2012.2.jns112132 ◽

2012 ◽

Vol 116 (5) ◽

pp. 1093-1096 ◽

Cited By ~ 70

Author(s):

Sarah T. Garber ◽

Walavan Sivakumar ◽

Richard H. Schmidt

Keyword(s):

Atrial Fibrillation ◽

Randomized Clinical Trials ◽

Dabigatran Etexilate ◽

Ground Level ◽

Thrombin Inhibitors ◽

Thrombin Inhibitor ◽

Direct Thrombin Inhibitors ◽

Systemic Embolism ◽

Nonvalvular Atrial Fibrillation ◽

Reversal Agent

Dabigatran etexilate is an oral anticoagulant that acts as a direct, competitive thrombin inhibitor. Large randomized clinical trials have shown higher doses of dabigatran (150 mg taken twice daily) to be superior to warfarin in terms of stroke and systemic embolism rates in patients with nonvalvular atrial fibrillation. As a result, in 2010 the US FDA approved the use of dabigatran for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Dabigatran is especially attractive in the outpatient setting because patients do not require routine monitoring with prothrombin times or international normalized ratios. To date, no effective reversal agent for dabigatran in the event of catastrophic hemorrhage has been identified. The authors report a case of an elderly patient, being treated with dabigatran for atrial fibrillation, who presented with a rapidly expanding intracranial hemorrhage after a ground-level fall. This case highlights an impending neurosurgical quandary of complications secondary to this new anticoagulation agent and suggests potential options for management.

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