P1652: safety of doacs in patients with chronic kidney disease: a systematic review and meta-analysis

Topic: 34. Thrombosis and vascular biology - Biology & Translational Research Background: Direct oral anticoagulants (DOACs) are now the standard of care for management of venous thromboembolism (VTE) and stroke prophylaxis in atrial fibrillation. Patients with chronic kidney disease (CKD) are at increased risk of VTE and atrial fibrillation. As DOACs are partially renally cleared and patients with CrCl<25-30 were excluded from large trials, there remains question of the safety of DOACs in patients with CKD. Aims: To synthesize primary evidence on the safety profile of DOACs in patients with CKD. Methods: We conducted a search of MEDLINE and Embase from database inception to January 2023. We included randomized controlled trials (RCTs) and cohort studies of any DOACs compared to vitamin K antagonists for prevention of thrombosis in patients with CKD. Two reviewers screened and extracted data at title/abstract and full-text levels individually and in duplicate. Baseline characteristics, anticoagulation regimen, and CKD stage were extracted. Primary outcome was ISTH major bleeding stratified by CKD stage. Data were meta-analyzed using random-effects model and presented as odds ratios with corresponding 95% confidence intervals. Results: Of the 2772 articles screened, 33 cohort studies and 7 RCTs comprised of 283690 patients were included. There was a non-significant reduction of major bleeding that favored DOACs for stage 3 CKD (OR=0.78 [0.59, 1.05]), stage 4 CKD (OR=0.82 [0.52, 1.25]), and stage 5 CKD (OR= 0.84 [0.58, 1.21]). Summary/Conclusion: In this preliminary analysis comparing DOACs to VKAs, DOACs were associated with a statistically non-significant reduction in major bleeding across stage 3-5 CKD. Further analyses are in process which will stratify by DOAC agent, duration, dosage, renal replacement therapy, and include secondary efficacy outcomes. Figure 1. DOAC vs Vitamin K Antagonist for the Risk of Major Bleeding Stratified by CKD StageKeywords: Venous thromboembolism, Oral anticoagulant, Chronic renal failure