Abstract
Background: Detection of severe renal impairment in patients with venous thromboembolism (VTE) is mandatory both for selecting anticoagulant therapy and for evaluating major bleeding risk, increased by severe renal impairment. Objectives: To determine whether the Cockcroft and Gault (CG) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formulas identify severe renal impairment in the same VTE patients presenting the same risk of major bleeding. Patients/Methods: We compared clinical characteristics and outcomes during the first 3 months of anticoagulation between VTE patients in the RIETE registry with severe renal impairment according to the CG and/or CKD-EPI formula (estimated glomerular filtration rate <30 mL/min and <30 mL/min/1.73 m2, respectively). The primary outcome was major bleeding. Results: Up to October 2017, 41 796 patients were included in RIETE. Among the 4676 patients with severe renal impairment according to at least one of the formulas, this was not confirmed by the other formula in 1904 (40.7%). Major bleeding risk was increased in every patient subgroup with severe renal impairment vs patients without this condition (CG or CKD-EPI < 30: odds ratio [OR] = 2.26, 95% confidence interval [CI 2.01-2.53], only CG < 30: OR = 1.72, 95% CI [1.37-2.13], only CKD-EPI < 30: OR = 2.34, 95% CI [1.77-3.05], CG+CKD-EPI < 30: OR = 2.47, 95% CI [2.16-2.83], all vs CG+CKD-EPI > 30). Conclusion: The CG and CKD-EPI formulas identify different subgroups of patients with severe renal impairment, leading to discordant results in 40.7% of these patients. Irrespective of the formula used for their identification, patients with severe renal impairment have a higher risk of major bleeding under anticoagulant therapy.
| Original language | English |
|---|---|
| Pages (from-to) | 1728-1737 |
| Number of pages | 10 |
| Journal | Journal of Thrombosis and Haemostasis |
| Volume | 18 |
| Issue number | 7 |
| DOIs | |
| State | Published - 1 Jul 2020 |
Bibliographical note
Publisher Copyright:© 2020 International Society on Thrombosis and Haemostasis
Funding
The authors warmly thank Ms Paula Harry for revising the English. We express our gratitude to Sanofi Spain for supporting this Registry with an unrestricted educational grant. We are also grateful to Bayer Pharma AG for supporting this Registry. Bayer Pharma AG's support was limited to the part of RIETE located outside Spain, which accounts for 25.31% of the total number of patients included in the RIETE Registry. We also thank the RIETE Registry Coordinating Center, S&H Medical Science Service, for their quality control data, logistic, and administrative support. Dr. Catella‐Chatron reports nonfinancial support from Bristol‐Myers Squibb, unrelated to the submitted work. Dr. Bertoletti reports personal fees and nonfinancial support from Bayer, personal fees and nonfinancial support from Leo‐Pharma, personal fees and nonfinancial support from Aspen, personal fees and nonfinancial support from BMS‐Pfizer, and nonfinancial support from Daiichi, unrelated to the submitted work. Dr. Mismetti reports grants, personal fees, and other support from Bayer, personal fees from Daiichi Sankyo, personal fees from BMS/Pfizer, personal fees from Boehringer Ingelheim, and personal fees from Sanofi, unrelated to the submitted work. Dr. Ollier, Dr. Samperiz, Dr. Soler, Dr. Suriñach, Dr. Mahe, Dr. Lorente, Dr. Braester, and Dr. Monreal have nothing to disclose.
| Funders | Funder number |
|---|---|
| S&H Medical Science Service | |
| Bayer |
Keywords
- anticoagulants
- glomerular filtration rate
- hemorrhage
- renal insufficiency
- venous thromboembolism