title: Novel Oral Anticoagulants and the Risk of Major Hemorrhage in Elderly Patients With Chronic Kidney Disease: A Nested Case-Control Study.
abstract: The novel oral anticoagulants, including dabigatran and rivaroxaban, differ in their degree of renal excretion.
  
  
  
  We conducted a population-based nested case-control study in patients 66 years and older with chronic kidney disease (CKD) (excluding patients undergoing chronic dialysis) who received an oral anticoagulant between April 2006 and March 2013. We calculated odds ratios for hospitalization with a major hemorrhagic event and receipt of dabigatran, rivaroxaban, or warfarin in the preceding 60 days. We also performed a sensitivity analysis to investigate whether a relationship exists between major hemorrhage and advanced age (age < 80 years or ≥ 80 years).
  
  
  
  We identified 237,409 patients with CKD, 4470 (1.9%) of whom experienced a major hemorrhage. We matched these patients to 14,460 controls. The use of dabigatran or rivaroxaban was not associated with a statistically significant elevated risk of hemorrhage compared with warfarin (adjusted odds ratio [aOR], 1.15; 95% confidence interval [CI], 0.91-1.45 for dabigatran; aOR, 1.22; 95% CI, 0.83-1.79 for rivaroxaban). Our sensitivity analysis found that older age was associated with an increased risk of hemorrhage for patients receiving dabigatran (aOR, 1.41; 95% CI, 1.06-1.88); results were similar but did not reach statistical significance for rivaroxaban (aOR, 1.57; 95% CI, 0.91-2.69).
  
  
  
  Among elderly patients with CKD, exposure to dabigatran or rivaroxaban was not associated with a statistically significant increased risk of major hemorrhagic events compared with exposure to warfarin.
authors.affiliation: Division of Nephrology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; The Keenan Research Centre in the Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada. Electronic address: harelz@smh.ca.
authors.forename: Ziv
authors.initials: Z
authors.lastname: Harel
authors.affiliation: The Keenan Research Centre in the Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Mamdani
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada; Department of Medicine, Sunnybrook Hospital, University of Toronto, Toronto, Ontario, Canada.
authors.forename: David N
authors.initials: DN
authors.lastname: Juurlink
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada; Division of Nephrology, London Health Sciences Centre, Western University, London, Ontario, Canada.
authors.forename: Amit X
authors.initials: AX
authors.lastname: Garg
authors.affiliation: Division of Nephrology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; The Keenan Research Centre in the Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Ron
authors.initials: R
authors.lastname: Wald
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
authors.forename: Zhan
authors.initials: Z
authors.lastname: Yao
authors.affiliation: The Keenan Research Centre in the Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
authors.forename: Tara
authors.initials: T
authors.lastname: Gomes
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects*; D016022:Case-Control Studies; D000069604:Dabigatran / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D008297:Male; D009864:Ontario / Q000453:epidemiology; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology*; D012306:Risk; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000009:adverse effects; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D000069552:Rivaroxaban; D000069604:Dabigatran