OBJECTIVE: To assess perioperative management and outcomes in patients who are receiving low-dose rivaroxaban, 2.5 mg twice-daily, and low-dose ASA, 81 to 100 mg daily. To assess perioperative management and outcomes in patients who are receiving low-dose rivaroxaban, 2.5 mg twice-daily, and low-dose ASA, 81 to 100 mg daily.
METHODS: Subanalysis of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial was performed to assess perioperative management and clinical outcomes in patients with stable coronary or peripheral artery disease who were randomized to receive rivaroxaban 2.5 mg twice a day plus ASA 100 mg daily, rivaroxaban 5 mg twice a day, or ASA 100 mg daily. Patients studied required a surgery/procedure during the trial. The study outcomes, which included myocardial infarction, angina, stroke, acute limb ischemia, bleeding, and death, were assessed according to treatment allocation.
RESULTS: There were 2632 patients studied (mean age, 68 years; 80% male) who had a surgery/procedure, comprising percutaneous coronary interventions (∼43%), carotid or other arterial angioplasty (∼15%), pacemaker or internal cardiac defibrillator implantation (∼9%), and coronary artery bypass graft surgery (∼7%). Perioperative study drug management varied, with about one-third of patients not interrupting study drug and the remainder interrupting it between 1 and ≥10 days preprocedure. The incidences of adverse outcomes across treatment groups were 12.7% to 15.3% for myocardial ischemia, 0.8% to 1.2% for stroke, 0.1% to 0.2% for venous thromboembolism, and 3.1% to 4.2% for any bleeding. There was no statistically significant difference in outcome rates across treatment groups.
CONCLUSIONS: In patients in the COMPASS trial who required a surgery/procedure, there was no significant difference in perioperative adverse outcomes whether patients were receiving rivaroxaban 2.5 mg twice a day and ASA 100 mg daily, rivaroxaban 5 mg twice a day, or ASA alone.
方法:COMPASS试验的子分析,以评估稳定型冠状动脉或外周动脉疾病患者的围手术期管理和临床结局,这些患者随机接受利伐沙班2.5mgbid加ASA100mg/天,利伐沙班5mgbid,或ASA每天100毫克。研究的患者在试验期间需要手术/程序。研究结果,其中包括心肌梗塞,心绞痛,中风,急性肢体缺血,出血,和死亡,根据治疗分配进行评估。
结果:研究了2,632例患者(平均年龄,68岁;80%男性)接受过手术/手术,包括经皮冠状动脉介入治疗(~43%),颈动脉或其他动脉血管成形术(~15%),起搏器或内部心脏除颤器植入(~9%),和冠状动脉搭桥术(7%)。围手术期研究药物管理多种多样,约三分之一的患者未中断研究药物,其余患者在术前1天至≥10天之间中断研究药物。不同治疗组的心肌缺血不良结局发生率为12.7%~15.3%,中风的0.8%至1.2%,静脉血栓栓塞的0.1%至0.2%,和3.1%至4.2%的任何出血。各治疗组的转归率无统计学差异。
结论:在COMPASS试验中需要手术/程序的患者中,无论患者接受利伐沙班2.5mgbid还是每天接受ASA100mg,围手术期不良结局均无显著差异。利伐沙班5mgbid或单独ASA。