Study: Rivaroxaban shows similar safety, effectiveness to warfarin for patients with CKD
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Key takeaways:
- Overall, 1,144 bleeding events occurred by the 1-year follow-up period.
- There were 577 ischemic stroke or transient ischemic attack events and 4,287 deaths.
Rivaroxaban showed similar or lower risk for death, ischemic stroke and transient ischemic attack, and similar risk for bleeding compared with warfarin in adults with atrial fibrillation, according to recently published data.
In a population-based study conducted in Australia and Canada, researchers compared the effectiveness of rivaroxaban to warfarin in patients with chronic kidney disease across a range of kidney function. The aim was to assess patients with atrial fibrillation (AF) who received either drug across a range of eGFR levels.
“Direct oral anticoagulants are now a mainstay of anticoagulant therapy for the prevention of cardiovascular thrombotic event,” Jeffrey T. Ha, BSc, MBBS, FRACP, of the renal and metabolic division at The George Institute for Global Health in Sydney, and colleagues, wrote.
Ha and colleagues conducted a large, multicenter cohort study of adults with AF to assess the safety of rivaroxaban compared with warfarin. The retrospective study included 55,568 patients with AF and analyzed administrative data from five jurisdictions across Australia and Canada from 2011 to 2018. Patients were categorized based on eGFR levels, with kidney function classified as an eGFR greater than or equal to 60 mL/min/1.73 m2, 45 mL/min/1.73 m2 to 59 mL/min/1.73 m2, 30 mL/min/1.73 m2 to 44 mL/min/1.73 m2 and less than 30 mL/min/1.73 m2.
A total of 4,733 (8.5%) patients experienced the effectiveness outcome, which was the 1-year composite outcomes of all-cause death, first hospitalization for ischemic stroke or transient ischemic attack (TIA), according to study results. There were 577 (1%) ischemic stroke or TIA events and 4,287 (7.7%) deaths. Overall, 1,144 bleeding events occurred. The incidence of major bleeding outcomes increased with progressively lower eGFR in both drugs. Compared with warfarin, rivaroxaban was associated with greater or similar effectiveness across a broad range of kidney function, according to study results.
“In adults with AF, rivaroxaban vs. warfarin was associated with lower or similar risk of all-cause death, ischemic stroke and [TIA] and similar risk of bleeding,” the researchers wrote.
Rivaroxaban initiation showed HRs of 0.72, 0.78, 0.70 and 0.78 for eGFR greater than or equal to 60 mL/min/1.73 m2, 45 mL/min/1.73 m2 to 59 mL/min/1.73 m2, 30 mL/min/1.73 m2 to 44 mL/min/1.73 m2 and less than 30 mL/min/1.73 m2, respectively. It also showed a similar risk of major bleeding events, including intracranial, gastrointestinal or other bleeding, across all eGFR categories with HRs of 0.75, 1.01, 0.87 and 0.63 for eGFR greater than 60 mL/min/1.73 m2, 45 mL/min/1.73 m2 to 59 mL/min/1.73 m2, 30 mL/min/1.73 m2 to 44 mL/min/1.73 m2, and less than 30 mL/min/1.73 m2, respectively.
Overall, 46% of rivaroxaban users were given a reduced dose, according to the study. Of patients with eGFR greater than or equal to 60 mL/min/1.73 m2, 45 mL/min/1.73 m2 to 59 mL/min/1.73 m2, 30 mL/min/1.73 m2 to 44 mL/min/1.73 m2, and less than 30 mL/min/1.73 m2, patients prescribed reduced doses were 36%, 53%, 77% and 86%, respectively.
“This study adds important safety data on the use of rivaroxaban in patients with reduced kidney function including ... in whom the risks and benefits of rivaroxaban use is most uncertain,” the researchers wrote. This research supports rivaroxaban as a “safe and effective alternative to warfarin for [AF] across differing levels of kidney function.”
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