Tze-Fan Chao1,2, Yi-Hsin Chan3,4,5, Chern-En Chiang6,7,8, Ta-Chuan Tuan6,7, Jo-Nan Liao6,7, Tzeng-Ji Chen9, Gregory Y H Lip10,11, Shih-Ann Chen6,7,12. 1. Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. eyckeyck@gmail.com. 2. Institute of Clinical Medicine, and Cardiovascular Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. eyckeyck@gmail.com. 3. The Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan. 4. College of Medicine, Chang Gung University, Taoyuan, Taiwan. 5. Microscopy Core Laboratory, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan. 6. Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. 7. Institute of Clinical Medicine, and Cardiovascular Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan. 8. General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan. 9. Department of Family Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. 10. Liverpool Centre for Cardiovascular Science, University of Liverpool & Liverpool Heart and Chest Hospital, Liverpool, UK. 11. Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 12. Cardiovascular Center, Taichung Veterans General Hospital, Taichung, Taiwan.
Abstract
BACKGROUND: The bleeding risk profile of patients with atrial fibrillation (AF) may change over time, and the increment of HAS-BLED score is perceived to result in discontinuations of oral anticoagulants (OACs). OBJECTIVES: To investigate the changes of HAS-BLED scores of AF patients initially with a low bleeding risk. The associations between continuation or discontinuation of OACs and clinical outcomes after patients' bleeding risk profile worsened (ie HAS-BLED increased) were studied. METHODS: The present study used Taiwan nationwide health insurance research database. From year 2000 to 2015, a total of 24,990 AF patients aged ≥ 20 years with a CHA2DS2-VASc score ≥ 1 (males) or ≥ 2 (females) having an HAS-BLED score of 0-2 who were treated with OACs were identified and followed up for changes of the HAS-BLED scores. Patients who did not refill OACs within 90 days after their HAS-BLED scores increased to ≥ 3 were defined as discontinuations of OACs. The risks of clinical outcomes were compared between patients who continued or stopped OACs once their HAS-BLED scores increased to ≥ 3. RESULTS: Mean HAS-BLED score of study population increased from 1.54 to 3.33. At end of 1 year, 5,229 (20.9%) patients had an increment of their HAS-BLED scores to ≥ 3, mainly due to newly diagnosed hypertension, stroke, bleeding, and concomitant drug therapies. Among 4777 patients who consistently had an HAS-BLED score ≥ 3, 1,062 (22.2%) stopped their use of OACs. Patients who kept on OACs (n = 3715; 77.8%) even after their HAS-BLED scores increased to ≥ 3 were associated with a lower risk of ischemic stroke (aHR 0.60, 95%CI 0.53-0.69), major bleeding (aHR 0.78, 95%CI 0.67-0.91), all-cause mortality (aHR 0.88, 95%CI 0.79-0.97), and any adverse events (aHR 0.75, 95%CI 0.68-0.82) adjusted for age, sex, heart failure, and HAS-BLED score. These results were consistent among the cohorts after propensity matching. CONCLUSIONS: For patients whose HAS-BLED scores increased to ≥ 3, the continuation of OACs was associated with better clinical outcomes. An increased HAS-BLED score in anticoagulated AF patients may not be the only reason to withhold OACs, but reminds physicians to correct modifiable bleeding risk factors and follow up patients more closely. Associations between Continuation or Discontinuation of Oral Anticoagulants and Risks of Clinical Outcomes after HAS-BLED Scores Increased AF atrial fibrillation; aHR adjusted hazard ratio; ICH intra-cranial hemorrhage; OACs oral anticoagulants.
BACKGROUND: The bleeding risk profile of patients with atrial fibrillation (AF) may change over time, and the increment of HAS-BLED score is perceived to result in discontinuations of oral anticoagulants (OACs). OBJECTIVES: To investigate the changes of HAS-BLED scores of AF patients initially with a low bleeding risk. The associations between continuation or discontinuation of OACs and clinical outcomes after patients' bleeding risk profile worsened (ie HAS-BLED increased) were studied. METHODS: The present study used Taiwan nationwide health insurance research database. From year 2000 to 2015, a total of 24,990 AF patients aged ≥ 20 years with a CHA2DS2-VASc score ≥ 1 (males) or ≥ 2 (females) having an HAS-BLED score of 0-2 who were treated with OACs were identified and followed up for changes of the HAS-BLED scores. Patients who did not refill OACs within 90 days after their HAS-BLED scores increased to ≥ 3 were defined as discontinuations of OACs. The risks of clinical outcomes were compared between patients who continued or stopped OACs once their HAS-BLED scores increased to ≥ 3. RESULTS: Mean HAS-BLED score of study population increased from 1.54 to 3.33. At end of 1 year, 5,229 (20.9%) patients had an increment of their HAS-BLED scores to ≥ 3, mainly due to newly diagnosed hypertension, stroke, bleeding, and concomitant drug therapies. Among 4777 patients who consistently had an HAS-BLED score ≥ 3, 1,062 (22.2%) stopped their use of OACs. Patients who kept on OACs (n = 3715; 77.8%) even after their HAS-BLED scores increased to ≥ 3 were associated with a lower risk of ischemic stroke (aHR 0.60, 95%CI 0.53-0.69), major bleeding (aHR 0.78, 95%CI 0.67-0.91), all-cause mortality (aHR 0.88, 95%CI 0.79-0.97), and any adverse events (aHR 0.75, 95%CI 0.68-0.82) adjusted for age, sex, heart failure, and HAS-BLED score. These results were consistent among the cohorts after propensity matching. CONCLUSIONS: For patients whose HAS-BLED scores increased to ≥ 3, the continuation of OACs was associated with better clinical outcomes. An increased HAS-BLED score in anticoagulated AF patients may not be the only reason to withhold OACs, but reminds physicians to correct modifiable bleeding risk factors and follow up patients more closely. Associations between Continuation or Discontinuation of Oral Anticoagulants and Risks of Clinical Outcomes after HAS-BLED Scores Increased AF atrial fibrillation; aHR adjusted hazard ratio; ICH intra-cranial hemorrhage; OACs oral anticoagulants.