Luca Di Lullo1, Giovanni Tripepi2, Claudio Ronco3, Antonio De Pascalis4, Vincenzo Barbera5, Antonio Granata6, Domenico Russo7, Biagio Raffaele Di Iorio8, Ernesto Paoletti9, Maura Ravera9, Maria Fusaro10, Antonio Bellasi11. 1. Department of Nephrology and Dialysis, L. Parodi - Delfino Hospital, Colleferro, Italy. dilulloluca69@gmail.com. 2. Research Unit of Reggio Calabria, Institute of Clinical Physiology, National Research Council (IFC-CNR), Reggio Calabria, Italy. 3. International Renal Research Institute, S. Bortolo Hospital, Vicenza, Italy. 4. Department of Nephrology and Dialysis, V. Fazzi Hospital, Lecce, Italy. 5. Department of Nephrology and Dialysis, L. Parodi - Delfino Hospital, Colleferro, Italy. 6. Department of Nephrology and Dialysis, S. Giovanni di Dio Hospital, Agrigento, Italy. 7. Division of Nephrology, Federico II University, Naples, Italy. 8. Department of Nephrology and Dialysis, Landolfi Hospital, Solofra, Italy. 9. Department of Nephrology and Dialysis, S. Martino Hospital, Genoa, Italy. 10. Department of Medicine, University of Padova, Padua, Italy. 11. Department of Nephrology and Dialysis, S. Anna Hospital, ASST Lariana, Como, Italy. antoniobellasi@gmail.com.
Abstract
BACKGROUND: In recent years, novel anticoagulant drugs have been introduced in the clinical armamentarium and have progressively gained momentum. Although their use is increasing among CKD patients, some skepticism about their risk-benefit ratio still persists. We sought to investigate the safety and effectiveness of rivaroxaban in a cohort of moderate-to-advanced CKD patients. METHODS: This observational, retrospective, longitudinal study involved 347 consecutive CKD stage 3b-4 (according to NKF-KDOQI guidelines) patients enrolled from 8 cardiac outpatient clinics between March 2015 and October 2017. All patients received anticoagulation (100 warfarin vs. 247 rivaroxaban) as part of their non-valvular atrial fibrillation management at the attending physician's discretion. Clinical effectiveness (defined as the occurrence of ischemic stroke, venous thromboembolism, or transient ischemic attack) and safety (intracranial hemorrhage, gastrointestinal or other bleeding) were assessed separately. RESULTS: Over a mean follow-up period of 16 ± 0.3 months, 25 stroke episodes (15 hemorrhagic, and 10 ischemic) occurred in 24 warfarin treated patients vs. none in the rivaroxaban arm. There were 5 vs. 0 episodes of deep venous thrombosis and 8 vs. 2 major episodes of bleeding in the warfarin and rivaroxaban groups, respectively. In contrast, the proportion of minor episodes of bleeding was similar between groups. CONCLUSION: Rivaroxaban seems a safe and effective therapeutic option in CKD stage 3b-4 patients. However, future randomized controlled trials are needed to definitively establish the role of rivaroxaban in CKD patients.
BACKGROUND: In recent years, novel anticoagulant drugs have been introduced in the clinical armamentarium and have progressively gained momentum. Although their use is increasing among CKDpatients, some skepticism about their risk-benefit ratio still persists. We sought to investigate the safety and effectiveness of rivaroxaban in a cohort of moderate-to-advanced CKDpatients. METHODS: This observational, retrospective, longitudinal study involved 347 consecutive CKD stage 3b-4 (according to NKF-KDOQI guidelines) patients enrolled from 8 cardiac outpatient clinics between March 2015 and October 2017. All patients received anticoagulation (100 warfarin vs. 247 rivaroxaban) as part of their non-valvular atrial fibrillation management at the attending physician's discretion. Clinical effectiveness (defined as the occurrence of ischemic stroke, venous thromboembolism, or transient ischemic attack) and safety (intracranial hemorrhage, gastrointestinal or other bleeding) were assessed separately. RESULTS: Over a mean follow-up period of 16 ± 0.3 months, 25 stroke episodes (15 hemorrhagic, and 10 ischemic) occurred in 24 warfarin treated patients vs. none in the rivaroxaban arm. There were 5 vs. 0 episodes of deep venous thrombosis and 8 vs. 2 major episodes of bleeding in the warfarin and rivaroxaban groups, respectively. In contrast, the proportion of minor episodes of bleeding was similar between groups. CONCLUSION:Rivaroxaban seems a safe and effective therapeutic option in CKD stage 3b-4 patients. However, future randomized controlled trials are needed to definitively establish the role of rivaroxaban in CKDpatients.
Authors: L Di Lullo; C Ronco; M Cozzolino; D Russo; L Russo; B Di Iorio; A De Pascalis; V Barbera; M Galliani; E Vitaliano; C Campana; F Santoboni; A Bellasi Journal: Thromb Res Date: 2017-05-04 Impact factor: 3.944
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