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Gastrointestinal Bleeding With Edoxaban Versus Warfarin
- Source :
- Circulation: Cardiovascular Quality and Outcomes. 11
- Publication Year :
- 2018
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2018.
-
Abstract
- Background: The ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation–Thrombolysis In Myocardial Infarction) compared higher-dose edoxaban regimen (HD-ER) and lower-dose edoxaban regimen with well-managed warfarin in 21 105 patients with atrial fibrillation. The risk factors and clinical impact of gastrointestinal bleeding (GIB) in this trial have not been described in detail. Methods and Results: This analysis was undertaken to identify risk factors for major GIB (MGIB) and compare the severity and outcomes of GIB with edoxaban and warfarin. During 2.8 years mean follow-up, there were 579 MGIB (1.22% per year), of which 63 were life-threatening or fatal (0.13% per year). Male sex, increased age, prior GIB, concomitant aspirin, lower baseline hemoglobin, renal dysfunction, and higher HAS-BLED and CHADS 2 scores were independently associated with the risk of MGIB. Whereas the annual rate of MGIB was higher with HD-ER than with warfarin (1.53% and 1.25%, respectively; hazard ratio, 1.23; 95% confidence interval, 1.02–1.48; P =0.033), the annual rates of life-threatening or fatal GIB were similar (0.15% and 0.18%, respectively). Several indicators of more severe GIB, including hemodynamic instability, hospitalization, ≥ 4 U transfusion, and hemoglobin loss ≥5 g/dL, were similar with HD-ER and warfarin, whereas surgery required to manage bleeding was less frequent with HD-ER. Lower-dose edoxaban regimen, which achieved 50% lower trough edoxaban levels, was associated with significantly less MGIB than warfarin. Conclusions: MGIB occurred more frequently with HD-ER than warfarin. The rates of life-threatening or fatal GIB were low and similar with both HD-ER and warfarin. Clinical outcomes were generally favorable. The correlation between dose, trough edoxaban level, and the risk of GIB risk suggests GIB is exposure-related. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00781391.
- Subjects :
- Male
Gastrointestinal bleeding
medicine.medical_specialty
Time Factors
Pyridines
030204 cardiovascular system & hematology
Risk Assessment
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Risk Factors
Edoxaban
Internal medicine
Atrial Fibrillation
medicine
Humans
International Normalized Ratio
030212 general & internal medicine
Blood Coagulation
Aged
Randomized Controlled Trials as Topic
Retrospective Studies
Aspirin
Dose-Response Relationship, Drug
business.industry
Hazard ratio
Warfarin
Anticoagulants
Atrial fibrillation
Middle Aged
medicine.disease
Thiazoles
Regimen
Treatment Outcome
chemistry
Cardiology
Female
Drug Monitoring
Gastrointestinal Hemorrhage
Cardiology and Cardiovascular Medicine
business
TIMI
Factor Xa Inhibitors
medicine.drug
Subjects
Details
- ISSN :
- 19417705 and 19417713
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- Circulation: Cardiovascular Quality and Outcomes
- Accession number :
- edsair.doi.dedup.....ac1360f3018153638de6d8494e29c354