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Abstract：
OBJECTIVE: To compare the clinical benefits of rivaroxaban and warfarin in patients with non-valvular atrial fibrillation (NVAF) with high bleeding risk.
METHODS: A retrospective study was conducted on patients with high bleeding risk NVAF who were hospitalized at the First Affiliated Hospital of Zhengzhou University between May 31, 2016 and May 31, 2019 and took at least rivaroxaban and warfarin. The clinical benefits of both drugs were assessed by efficacy benefit and safety risk. The primary efficacy benefit was a composite end point for stroke (both ischemic and hemorrhagic) and systemic embolism. The secondary efficacy end points were death and myocardial infarction (MI). The principal safety end point was the composite end point of fatal bleeding and critical organ bleeding.
RESULTS: A total of 1,246 patients with high bleeding risk were enrolled, including 787 patients in the rivaroxaban group and 459 patients in the warfarin group. Results of the primary efficacy benefit endpoint were obtained from 104 patients (13.2%) in the rivaroxaban group and 88 (19.2%) patients in the warfarin group (hazard ratio [HR]: 0.681; 95% confidence interval [CI]: 0.512-0.906; P < 0.001 for non-inferiority). The principal safety end points were observed in 49 (6.23%) patients in the rivaroxaban group and in 55 (11.98%) patients in the warfarin group (HR: 0.469 in the rivaroxaban group; 95% CI: 0.314-0.702; P < 0.001). With respect to secondary efficacy and benefit endpoints, 28 (3.56%) patients in the rivaroxaban group and 22 (4.79%) patients in the warfarin group died, with an HR of 0.760 (95% CI: 0.435-1.329; P = 0.336); 32 (4.07%) patients in the rivaroxaban group; and 26 (5.66%) patients in the warfarin group had MI, with an HR of 1.940 (95% CI: 0.495-1.069, P = 0.254) in the rivaroxaban group.
CONCLUSIONS: Rivaroxaban is non-inferior to warfarin in the prevention of stroke and systemic embolism in patients with high blood NVAF. Rivaroxaban is superior to warfarin in reducing fatal bleeding and bleeding in critical organs.
BACKGROUND: Chinese Clinical Trials Registry, identifier ChiCTR2100052454.
METHODS: A retrospective study was conducted on patients with high bleeding risk NVAF who were hospitalized at the First Affiliated Hospital of Zhengzhou University between May 31, 2016 and May 31, 2019 and took at least rivaroxaban and warfarin. The clinical benefits of both drugs were assessed by efficacy benefit and safety risk. The primary efficacy benefit was a composite end point for stroke (both ischemic and hemorrhagic) and systemic embolism. The secondary efficacy end points were death and myocardial infarction (MI). The principal safety end point was the composite end point of fatal bleeding and critical organ bleeding.
RESULTS: A total of 1,246 patients with high bleeding risk were enrolled, including 787 patients in the rivaroxaban group and 459 patients in the warfarin group. Results of the primary efficacy benefit endpoint were obtained from 104 patients (13.2%) in the rivaroxaban group and 88 (19.2%) patients in the warfarin group (hazard ratio [HR]: 0.681; 95% confidence interval [CI]: 0.512-0.906; P < 0.001 for non-inferiority). The principal safety end points were observed in 49 (6.23%) patients in the rivaroxaban group and in 55 (11.98%) patients in the warfarin group (HR: 0.469 in the rivaroxaban group; 95% CI: 0.314-0.702; P < 0.001). With respect to secondary efficacy and benefit endpoints, 28 (3.56%) patients in the rivaroxaban group and 22 (4.79%) patients in the warfarin group died, with an HR of 0.760 (95% CI: 0.435-1.329; P = 0.336); 32 (4.07%) patients in the rivaroxaban group; and 26 (5.66%) patients in the warfarin group had MI, with an HR of 1.940 (95% CI: 0.495-1.069, P = 0.254) in the rivaroxaban group.
CONCLUSIONS: Rivaroxaban is non-inferior to warfarin in the prevention of stroke and systemic embolism in patients with high blood NVAF. Rivaroxaban is superior to warfarin in reducing fatal bleeding and bleeding in critical organs.
BACKGROUND: Chinese Clinical Trials Registry, identifier ChiCTR2100052454.
摘要：
目的：比较利伐沙班和华法林对高出血风险非瓣膜性心房颤动（NVAF）患者的临床疗效。
方法：对2016年5月31日至2019年5月31日在郑州大学第一附属医院住院且至少服用利伐沙班和华法林的高出血风险NVAF患者进行回顾性研究。通过疗效获益和安全风险评估两种药物的临床获益。主要疗效获益是卒中（缺血性和出血性）和全身性栓塞的复合终点。次要疗效终点为死亡和心肌梗死(MI)。主要安全终点是致命性出血和危重器官出血的复合终点。
结果：共纳入1,246例高出血风险患者，包括利伐沙班组787例患者和华法林组459例患者。利伐沙班组104例患者（13.2%）和华法林组88例患者（19.2%）获得主要疗效获益终点结果（风险比[HR]：0.681；95%置信区间[CI]：0.512-0.906；非劣效性P<0.001）。利伐沙班组49例(6.23%)患者和华法林组55例(11.98%)患者观察到主要安全终点(利伐沙班组HR:0.469;95%CI:0.314-0.702;P<0.001)。关于次要疗效和获益终点，利伐沙班组有28例(3.56%)患者死亡,华法林组有22例(4.79%)患者死亡,HR为0.760（95％CI：0.435-1.329；P=0.336）；利伐沙班组32例（4.07％）患者；华法林组26例（5.66％）患者患有MI，利伐沙班组的HR为1.940（95％CI：0.495-1.069，P=0.254）。
结论：利伐沙班在预防高血NVAF患者中风和全身性栓塞方面不劣于华法林。利伐沙班在减少致命性出血和关键器官出血方面优于华法林。
背景：中国临床试验注册中心，标识符ChiCTR2100052454。
方法：对2016年5月31日至2019年5月31日在郑州大学第一附属医院住院且至少服用利伐沙班和华法林的高出血风险NVAF患者进行回顾性研究。通过疗效获益和安全风险评估两种药物的临床获益。主要疗效获益是卒中（缺血性和出血性）和全身性栓塞的复合终点。次要疗效终点为死亡和心肌梗死(MI)。主要安全终点是致命性出血和危重器官出血的复合终点。
结果：共纳入1,246例高出血风险患者，包括利伐沙班组787例患者和华法林组459例患者。利伐沙班组104例患者（13.2%）和华法林组88例患者（19.2%）获得主要疗效获益终点结果（风险比[HR]：0.681；95%置信区间[CI]：0.512-0.906；非劣效性P<0.001）。利伐沙班组49例(6.23%)患者和华法林组55例(11.98%)患者观察到主要安全终点(利伐沙班组HR:0.469;95%CI:0.314-0.702;P<0.001)。关于次要疗效和获益终点，利伐沙班组有28例(3.56%)患者死亡,华法林组有22例(4.79%)患者死亡,HR为0.760（95％CI：0.435-1.329；P=0.336）；利伐沙班组32例（4.07％）患者；华法林组26例（5.66％）患者患有MI，利伐沙班组的HR为1.940（95％CI：0.495-1.069，P=0.254）。
结论：利伐沙班在预防高血NVAF患者中风和全身性栓塞方面不劣于华法林。利伐沙班在减少致命性出血和关键器官出血方面优于华法林。
背景：中国临床试验注册中心，标识符ChiCTR2100052454。
