Pharmacy Department, Beaumont Health, Royal Oak, MI.
Pharmacy Department, Detroit Medical Center, Detroit, MI.
Blood Adv. 2020 Jun 9;4(11):2366-2371. doi: 10.1182/bloodadvances.2019000972.
Apixaban in patients with impaired renal function is supported by limited data. Landmark clinical trials evaluating apixaban in patients with atrial fibrillation and/or acute venous thromboembolism excluded patients with creatinine clearance (CrCl) <25 mL/min. This multicenter, retrospective chart review was conducted to evaluate the safety and effectiveness of apixaban compared with warfarin in patients with CrCl <25 mL/min. Included patients were newly initiated on apixaban or warfarin for at least 45 days with a CrCl <25 mL/min. Patients were evaluated for thrombosis and bleeding outcomes 6 months following initiation of anticoagulation. The primary outcome was the time to first bleeding or thrombosis event. A total of 128 patients met inclusion criteria in the apixaban group and 733 patients in the warfarin group. Time to first bleeding or thrombosis event was significantly different between the apixaban and warfarin groups. Cox proportional hazards model was conducted to control for potential confounding factors for the primary outcome. After controlling for atrial fibrillation and coronary artery bypass grafting, risk of thrombotic and bleeding events was lower in the apixaban group (hazard ratio, 0.47; 95% confidence interval, 0.25-0.92). There was not a statistical difference between time to thrombosis (83 days vs 54 days, P = .648), rate of thrombosis (5.5% vs 10.3%, P = .08), time to bleeding (46 days vs 54 days, P = .886), or rate of bleeding (5.5% vs 10.9%, P = .06). The severity of bleeding and thrombotic events was not different between groups. Apixaban may serve as a reasonable alternative compared with warfarin in patients with severe renal dysfunction.
在肾功能受损的患者中，阿哌沙班的数据有限。评估房颤和/或急性静脉血栓栓塞患者阿哌沙班的关键性临床试验排除了肌酐清除率（CrCl）<25 mL/min 的患者。本多中心回顾性图表审查旨在评估与华法林相比，阿哌沙班在 CrCl<25 mL/min 的患者中的安全性和有效性。包括新开始使用阿哌沙班或华法林治疗且 CrCl<25 mL/min 的至少 45 天的患者。在开始抗凝后 6 个月评估血栓形成和出血结局。主要结局是首次出血或血栓形成事件的时间。阿哌沙班组共有 128 例患者符合纳入标准，华法林组共有 733 例患者。阿哌沙班组和华法林组之间首次出血或血栓形成事件的时间有显著差异。采用 Cox 比例风险模型控制主要结局的潜在混杂因素。在控制房颤和冠状动脉旁路移植术后，阿哌沙班组的血栓形成和出血事件风险较低（风险比，0.47；95%置信区间，0.25-0.92）。血栓形成时间（83 天比 54 天，P=.648）、血栓形成率（5.5%比 10.3%，P=.08）、出血时间（46 天比 54 天，P=.886）或出血率（5.5%比 10.9%，P=.06）之间无统计学差异。两组间出血和血栓形成事件的严重程度无差异。与华法林相比，阿哌沙班可能是严重肾功能不全患者的合理替代选择。
