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Ischemic Stroke and Systemic Embolism Among One-and-Done Direct Oral Anticoagulant Users with Non-valvular Atrial
Mark Alberts1, Maryia Zhdanava2, Dominic Pilon3
1Hartford Hospital, Hartford, CT, USA.
Insights
Patients discontinuing direct oral anticoagulants (DOACs) after initial fill face a higher risk of ischemic stroke/systemic embolism (SE). Continuous DOAC use is crucial for preventing severe complications in nonvalvular atrial fibrillation (NVAF).
Area of Science:
- Cardiology
- Neurology
- Pharmacology
Background:
- Direct oral anticoagulants (DOACs) are vital for preventing ischemic stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF).
- A significant number of patients discontinue DOACs after their first prescription, termed 'one-and-done' users.
Purpose of the Study:
- To compare the risk of ischemic stroke/SE between NVAF patients who discontinued DOACs after the first fill and those who continued therapy.
- To identify the implications of DOAC discontinuation on patient outcomes.
Main Methods:
- Retrospective cohort study using de-identified data from Symphony Health (April 2017-October 2020).
- Patients with NVAF initiated on DOACs were classified as 'one-and-done' (single fill within 90 days) or 'continuers' (multiple fills).
- Inverse probability of treatment weighting and survival analysis were employed to compare outcomes between balanced cohorts.
Main Results:
- 23.6% of patients initiating DOACs were classified as 'one-and-done' users.
- After weighting, the 'one-and-done' cohort (241,159 patients) showed a significantly higher 12-month probability of ischemic stroke/SE (1.44%) compared to the 'continuers' cohort (238,889 patients; 1.00%).
- The hazard ratio for ischemic stroke/SE in the 'one-and-done' group was 1.44 (95% CI: 1.34-1.54; p < 0.0001), with consistent findings in sensitivity analyses.
Conclusions:
- A substantial proportion of NVAF patients are 'one-and-done' DOAC users.
- DOAC discontinuation is associated with a significantly increased risk of ischemic stroke/SE.
- There is a critical need to improve access and adherence to continuous DOAC therapy to mitigate severe and fatal complications in NVAF patients.
Introduction:
Direct oral anticoagulants (DOACs) are essential in ischemic stroke/systemic embolism (SE) prevention among patients with nonvalvular atrial fibrillation (NVAF). This study compared the risk of ischemic stroke/SE among patients with NVAF who discontinued DOACs following the first fill ("one-and-done") relative to patients who continued DOACs beyond the first fill ("continuers").
Methods:
De-identified data from Symphony Health, an ICON plc Company, PatientSource®, April 1, 2017 to October 31, 2020, were used to identify adults with NVAF initiated on DOACs (index date). Patients with only one DOAC claim during the 90-day landmark period starting on the index date were classified as one-and-done and the remaining as continuers. Inverse probability of treatment weighting was used to balance baseline characteristics in the cohorts. Time from the landmark period end to the first ischemic stroke/SE event or, among those without the event, to clinical activity or data end was compared between balanced cohorts using survival analysis.
Results:
Of patients initiating DOACs, 23.6% were classified as one-and-done users. After weighting was performed, 241,159 and 238,889 patients comprised the one-and-done and continuer cohorts, respectively. At 12 months of follow-up, the probability of ischemic stroke/SE was 1.44% in the one-and-done cohort and 1.00% in the continuer cohort [hazard ratio (95% confidence interval) 1.44 (1.34-1.54); p < 0.0001]. Results at earlier and later time points and in a sensitivity analysis with a 75-day landmark period were similar.
Conclusion:
A substantial proportion of patients were one-and-done DOAC users, which was associated with significantly higher risk of ischemic stroke/SE events. There is an unmet need to improve access and encourage continuous use of DOACs among patients with NVAF so that severe and fatal complications may be mitigated.
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