Pereira Marcel de Paula, Lima Eduardo Gomes, Pitta Fabio Grunspun, Gowdak Luís Henrique Wolff, Mioto Bruno Mahler, Carvalho Leticia Neves Solon, Darrieux Francisco Carlos da Costa, Mejia Omar Asdrubal Vilca, Jatene Fabio Biscegli, Serrano Carlos Vicente
Instituto do coração, Hospital das clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brasil.
JTCVS Open. 2023 Jun 2;15:199-210. doi: 10.1016/j.xjon.2023.05.006. eCollection 2023 Sep.
Postoperative atrial fibrillation is the most common clinical complication after coronary artery bypass graft surgery. It is associated with a high risk of both stroke and death and increases the length of hospital stay and costs. This study aimed to evaluate anticoagulants in postoperative atrial fibrillation.
A single-center, randomized, prospective, and open-label study. The trial was conducted in Heart Institute at University of São Paulo, Brazil. Patients who developed postoperative atrial fibrillation were randomized to anticoagulation with rivaroxaban or warfarin plus enoxaparin bridging. The primary objective was the cost-effectiveness evaluated by quality-adjusted life years, using the SF-6D questionnaire. The secondary end point was the combination of death, stroke, myocardial infarction, thromboembolic events, infections, bleeding, readmissions, and surgical reinterventions. The safety end point was any bleeding using the International Society on Thrombosis and Haemostasis score. Follow-up period was 30 days after hospital discharge.
We analyzed 324 patients and 53 patients were randomized. The median cost-effectiveness was $1423.20 in the warfarin group versus $586.80 in the rivaroxaban group ( = .002). The median cost was lower in the rivaroxaban group, $450.20 versus $947.30 ( < .001). The secondary outcome was similar in both groups, 44.4% in warfarin group versus 38.5% in the rivaroxaban group ( = .65). Bleeding occured in 25.9% in the warfarin group versus 11.5% in the rivaroxaban group ( = .18).
Rivaroxaban was more cost-effective when compared with warfarin associated with enoxaparin bridging in postoperative atrial fibrillation after isolated coronary artery bypass grafting.
术后房颤是冠状动脉搭桥手术后最常见的临床并发症。它与中风和死亡的高风险相关,并增加住院时间和费用。本研究旨在评估抗凝剂在术后房颤中的应用。
一项单中心、随机、前瞻性、开放标签研究。该试验在巴西圣保罗大学心脏研究所进行。发生术后房颤的患者被随机分为接受利伐沙班抗凝或华法林加依诺肝素桥接抗凝。主要目标是使用SF-6D问卷通过质量调整生命年评估成本效益。次要终点是死亡、中风、心肌梗死、血栓栓塞事件、感染、出血、再入院和手术再次干预的综合情况。安全终点是使用国际血栓与止血学会评分的任何出血情况。随访期为出院后30天。
我们分析了324例患者,53例患者被随机分组。华法林组的中位成本效益为1423.20美元,而利伐沙班组为586.80美元(P = 0.002)。利伐沙班组的中位成本较低,分别为450.20美元和947.30美元(P < 0.001)。两组的次要结局相似,华法林组为44.4%,利伐沙班组为38.5%(P = 0.65)。华法林组出血发生率为25.9%,利伐沙班组为11.5%(P = 0.18)。
在孤立冠状动脉搭桥术后的术后房颤中,与华法林联合依诺肝素桥接相比,利伐沙班更具成本效益。