Dabigatran Versus Rivaroxaban for Secondary Stroke Prevention in Patients with Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities
Thromboembolic and bleeding risk are elevated in older patients with atrial fibrillation and prior stroke. We compared dabigatran with rivaroxaban for secondary prevention in a national population after skilled nursing facility (SNF) discharge.
Medicare fee-for-service beneficiaries aged ≥ 65 years with atrial fibrillation hospitalized for ischemic stroke (November 2011–October 2013) and subsequently admitted to an SNF were studied. Dabigatran (n = 332) and rivaroxaban users (n = 378) were compared in a retrospective, active comparator, new-user cohort. The index medication claim occurred within 120 days after hospital discharge and exposure continued until a 14-day treatment gap (‘as treated’). The primary net clinical benefit outcome was the time to recurrent stroke, transient ischemic attack, intracranial hemorrhage, extracranial bleed, myocardial infarction, venous thromboembolism, or death. All-cause mortality was evaluated separately as a secondary outcome. Multivariable adjusted Cox models stratified by dosage estimated hazard ratios (aHR).
Among those receiving low dosages, the crude composite event rate was 40.4/100 person-years among dabigatran users and 33.7/100 person-years among rivaroxaban users. The composite outcome [aHR 1.48; 95% confidence interval (CI) 0.87–2.51] and all-cause mortality (aHR 1.67; 95% CI 0.84–3.31) rates were higher among low-dose dabigatran users. For those receiving standard doses, the crude composite event rates were 19.5/100 person-years for dabigatran users and 37.1/100 person-years for rivaroxaban users. Although no difference in mortality was observed, the composite outcome rate was lower among standard-dose dabigatran users (aHR 0.65; 95% CI 0.36–1.15).
In older adults treated with direct-acting oral anticoagulants after ischemic stroke, outcome rates varied considerably by drug and dosage.
Compliance with Ethical Standards
The University of Massachusetts Medical School Institutional Review Board approved this study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of research formal consent is not required.
At the time the study was conducted, Dr Alcusky was funded by the National Center for Advancing Translational Sciences (TL1TR001454). Dr McManus was funded by the National Heart, Lung, and Blood Institute (RO1HL126911, RO1HL135219, RO1HL136660, R15HL121761). Partial support for Dr Goldberg was provided by the National Heart, Lung, and Blood Institute (1R01HL126911-01A1, 5R01HL125089-02, 5R01HL115295-05).
Conflict of interest
Dr. Tjia is a consultant for CVS Health. Dr. Alcusky, Dr. Goldberg, Dr. Fisher, Dr. Lapane, and Dr. Hume have no interests to disclose.
- 6.Sardar P, Chatterjee S, Wu WC, Lichstein E, Ghosh J, Aikat S, et al. New oral anticoagulants are not superior to warfarin in secondary prevention of stroke or transient ischemic attacks, but lower the risk of intracranial bleeding: insights from a meta-analysis and indirect treatment comparisons. PLoS One. 2013;8:e77694.CrossRefGoogle Scholar
- 10.Kanai Y, Oguro H, Tahara N, Matsuda H, Takayoshi H, Mitaki S, et al. Analysis of recurrent stroke volume and prognosis between warfarin and four non-vitamin k antagonist oral anticoagulants’ administration for secondary prevention of stroke. J Stroke Cerebrovasc Dis. 2018;27(2):338–45.CrossRefGoogle Scholar
- 14.Kumamaru H, Judd SE, Curtis JR, Ramachandran R, Hardy NC, Rhodes JD, et al. Validity of claims-based stroke algorithms in contemporary medicare data: reasons for geographic and racial differences in stroke (REGARDS) study linked with medicare claims. Circ Cardiovasc Qual Outcomes. 2014;7:611–9.CrossRefGoogle Scholar
- 25.Centers for Medicare and Medicaid Services. MDS 3.0 RAI Manual. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/MDS30RAIManual.html. Published October 1, 2016. Accessed 1 Sept 2017.
- 28.Steinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ, et al. Factors associated with non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with new-onset atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). Am Heart J. 2017;189:40–7.CrossRefGoogle Scholar
- 30.Ghaswalla PK, Harpe SE, Slattum PW. Warfarin use in nursing home residents: results from the 2004 national nursing home survey. Am J Geriatr Pharmacother. 2012;10(25–36):e2.Google Scholar
- 31.MacLean S, Mulla S, Akl EA, Jankowski M, Vandvik PO, Ebrahim S, et al. Patient values and preferences in decision making for antithrombotic therapy: a systematic review: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e1S–23S.CrossRefGoogle Scholar
- 35.Pradaxa [package insert]. Ridgefield, CT: Boehringer Ingelheim; 2012. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022512s000lbl.pdf. Accessed 25 June 2017.