Comparing Major Bleeding Risk in Outpatients With Atrial Fibrillation or Flutter by Oral Anticoagulant Type (from the National Cardiovascular Disease Registry's Practice Innovation and Clinical Excellence Registry) - 23/04/20
, Thomas M. Maddox, MD, MSc b, Kevin Kennedy, MS c, Richard E. Shaw, MA, PhD dHighlights |
• | DOACs have a favorable bleeding safety profile relative to warfarin. |
• | The bleeding safety profile associated with individual DOACs are not identical. |
• | Rivaroxaban was associated with higher gastrointestinal bleeding risk relative to warfarin. |
• | DOAC users 75 years and older had less safety benefit relative to warfarin users. |
Résumé |
Direct oral anticoagulants (DOACs) have a favorable bleeding risk profile in patients with atrial fibrillation (AF). However, the safety of individual DOACs relative to warfarin for specific bleeding outcomes is less certain. We identified 423,450 patients with AF between 2013 to 2015 in the NCDR PINNACLE national ambulatory registry matched to the Centers for Medicare and Medicaid Services database. Outcomes included time to first major bleed, intracranial hemorrhage (ICH), major gastrointestinal bleed (GIB), or other major bleed. We estimated the association of OAC with bleeding using Cox proportional hazard models. The median duration of follow-up was 1.4 years. OACs were used in 64% of AF patients (66% warfarin, 15% rivaroxaban, 12% dabigatran, and 7% apixaban). A major bleeding event occurred in 6.9% of patients. Compared with warfarin users, fewer patients experienced ICH with the use of rivaroxaban (HR 0.73; 95% CI 0.64 to 0.84), dabigatran (HR 0.56; 95% CI 0.48 to 0.65), and apixaban (HR 0.70; 95% CI 0.55 to 0.90). The risk of major GIB was higher in rivaroxaban users (HR 1.20; 95% CI 1.12 to 1.27), and lower in dabigatran (HR 0.88; 95% CI 0.82 to 0.95) and apixaban (HR 0.84; 95% CI 0.74 to 0.95) users. For any DOAC versus warfarin, age (≥75 or <75 years) interacted with major bleeding (HR 0.93 vs 0.78; p <0.001), GIB (HR 1.10 vs 0.82; p <0.001), and other major bleeding (HR 0.93 vs 0.80; p <0.001). In conclusion, our results suggest that the safety of DOACs is superior to warfarin in AF patients, except with rivaroxaban and GIB. Age ≥75 years attenuated the relative safety benefits of DOACs.
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| Funding/Support: This research was supported by the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). The PINNACLE (Practice Innovation and Clinical Excellence) Registry is an initiative of the American College of Cardiology Foundation. The PINNACLE Registry and the NCDR had no role in the design and conduct of the study and management, analysis, or interpretation of the data. |
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| Disclaimer: The views expressed in this article represent those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies identified at www.ncdr.com |
Vol 125 - N° 10
P. 1500-1507 - mai 2020 Retour au numéro
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