Novel Oral Anticoagulant Use Among Patients With Atrial Fibrillation Hospitalized With Ischemic Stroke or Transient Ischemic Attack

Background: The US Food and Drug Administration’s Sentinel Initiative is well positioned to support pragmatic clinical trials. FDA-Catalyst combines direct contact with health plan members and/or providers with data in the Sentinel infrastructure. Here, we describe the rationale, feasibility analyses, and lessons learned from the planning phase of the first large pragmatic trial conducted using the Sentinel Initiative’s delivery system capabilities—IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (the IMPACT-AFib trial). Methods: During the planning phase, we convened representatives from five commercial health plans, FDA, study coordinating centers, and a patient representative for protocol development, institutional review board preparation, and other activities. Administrative claims data from the plans were included in a retrospective cohort analysis to assess sample size for the trial. Members ≥30 years old with ≥365 days of medical/pharmacy coverage, ≥2 diagnosis codes for atrial fibrillation, a guideline-based indication for oral anticoagulant use for stroke prevention, and no evidence of oral anticoagulant use in the 365 days prior to the index atrial fibrillation diagnosis in 2013 were included. Exclusions for the analysis included other conditions requiring anticoagulation, history of intracranial hemorrhage, and gastrointestinal bleed. We calculated rates of oral anticoagulant use, transient ischemic attack or stroke, and bleeding in the 365 days following the index atrial fibrillation diagnosis. Results: A total of 44,786 members with atrial fibrillation with no evidence of recent oral anticoagulant use were identified. In total, 87% (n = 38,759) were classified as having a guideline-based indication for oral anticoagulants. Of those, 33% (n = 12,867) had a new oral anticoagulant dispensed during the following year, 15% (n = 5917) were hospitalized for stroke or transient ischemic attack, and 9% (n = 3469) for bleeding events. This information was used to develop the trial protocol including sample size, power calculations, and level of randomization. Conclusion: Sentinel infrastructure generated preliminary data that supported planning and implementation of a large pragmatic trial embedded in health plans. This planning identified unanticipated challenges that must be addressed in similar trials.

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Automated Continuous Electrocardiogram Monitoring Accelerates the Detection of Atrial Fibrillation after Ischemic Stroke or Transient Ischemic Attack on a Hyper Acute Stroke Unit

Journal of Stroke and Cerebrovascular Diseases ◽

10.1016/j.jstrokecerebrovasdis.2020.104669 ◽

2020 ◽

Vol 29 (4) ◽

pp. 104669

Author(s):

Lucio D'Anna ◽

Arindam Kar ◽

Zoe Brown ◽

Kirsten Harvey ◽

Soma Banerjee ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Acute Stroke ◽

Transient Ischemic Attack ◽

Stroke Unit ◽

Acute Stroke Unit ◽

Ischemic Attack ◽

Electrocardiogram Monitoring

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Detection of Atrial Fibrillation with Intermittent Handheld Electrocardiogram in Patients with Ischemic Stroke and Transient Ischemic Attack

Journal of Stroke and Cerebrovascular Diseases ◽

10.1016/j.jstrokecerebrovasdis.2016.07.010 ◽

2016 ◽

Vol 25 (11) ◽

pp. 2648-2652 ◽

Cited By ~ 3

Author(s):

Ann-Sofie Olsson ◽

Johan Engdahl

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Transient Ischemic Attack ◽

Ischemic Attack

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Associations between Pre-Admission Risk Scores and Two-Year Clinical Outcomes in Ischemic Stroke or Transient Ischemic Attack Patients with Non-Valvular Atrial Fibrillation

Cerebrovascular Diseases ◽

10.1159/000487896 ◽

2018 ◽

Vol 45 (3-4) ◽

pp. 170-179 ◽

Cited By ~ 1

Author(s):

Keisuke Tokunaga ◽

Hiroshi Yamagami ◽

Masatoshi Koga ◽

Kenichi Todo ◽

Kazumi Kimura ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Clinical Outcomes ◽

Scale Score ◽

Outcome Measures ◽

Transient Ischemic Attack ◽

Risk Scores ◽

Modified Rankin Scale ◽

Hemorrhagic Events ◽

Ischemic Attack

Background: We aimed to clarify associations between pre-admission risk scores (CHADS2, CHA2DS2-VASc, and HAS-BLED) and 2-year clinical outcomes in ischemic stroke or transient ischemic attack (TIA) patients with non-valvular atrial fibrillation (NVAF) using a prospective, multicenter, observational registry. Methods: From 18 Japanese stroke centers, ischemic stroke or TIA patients with NVAF hospitalized within 7 days after onset were enrolled. Outcome measures were defined as death/disability (modified Rankin Scale score ≥3) at 2 years, 2-year mortality, and ischemic or hemorrhagic events within 2 years. Results: A total of 1,192 patients with NVAF (527 women; mean age, 78 ± 10 years), including 1,141 ischemic stroke and 51 TIA, were analyzed. Rates of death/disability, mortality, and ischemic or hemorrhagic events increased significantly with increasing pre-admission CHADS2 (p for trend <0.001 for death/disability and mortality, p for trend = 0.024 for events), CHA2DS2-VASc (p for trend <0.001 for all), and HAS-BLED (p for trend = 0.004 for death/disability, p for trend <0.001 for mortality, p for trend = 0.024 for events) scores. Pre-admission CHADS2 (OR per 1 point, 1.52; 95% CI 1.35–1.71; p <0.001 for death/disability; hazard ratio (HR) per 1 point, 1.23; 95% CI 1.12–1.35; p <0.001 for mortality; HR per 1 point, 1.14; 95% CI 1.02–1.26; p = 0.016 for events), CHA2DS2-VASc (1.55, 1.41–1.72, p < 0.001; 1.21, 1.12–1.30, p < 0.001; 1.17, 1.07–1.27, p < 0.001; respectively), and HAS-BLED (1.33, 1.17–1.52, p < 0.001; 1.23, 1.10–1.38, p < 0.001; 1.18, 1.05–1.34, p = 0.008; respectively) scores were independently associated with all outcome measures. Conclusions: In ischemic stroke or TIA patients with NVAF, all pre-admission risk scores were independently associated with death/disability at 2 years and 2-year mortality, as well as ischemic or hemorrhagic events within 2 years.

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