Department of Anesthesiology, State Key Laboratory of Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
Department of Transfusion, State Key Laboratory of Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.
Cardiovasc Ther. 2018 Dec;36(6):e12472. doi: 10.1111/1755-5922.12472. Epub 2018 Nov 16.
Safety evaluations of tranexamic acid (TXA) remain sparse, especially with respect to its impact on long-term outcomes in patients undergoing on-pump coronary artery bypass grafting (CABG). We hypothesized that the effects of TXA on perioperative bleeding and allogeneic transfusion and its impact on long-term clinical outcomes of patients receiving on-pump CABG are superior to those in the control group.
In this prospective, randomized, placebo-controlled trial, 210 patients undergoing primary and isolated on-pump CABG were randomly assigned to receive TXA or a corresponding volume of saline solution. Randomly assigned patients were followed up at 1, 3, 5, and 7 years after hospital discharge. Finally, 163 patients fulfilled the 7-year follow-up. The primary outcome was allogeneic red blood cell (RBC) transfusion. Long-term mortality and morbidity were also evaluated.
Compared with placebo, TXA reduced the allogeneic RBC requirement in terms of the volume transfused (4.20 ± 4.06 vs 6.25 ± 4.86 units; P < 0.01), ratio exposed (52.0% vs 71.6%; P < 0.01), and blood loss volume (879.0 ± 392.5 vs 1154.0 ± 582.8 mL; P < 0.01). Except for myocardial infarction, there were no significant differences in mortality or morbidity between the two groups during the 7-year follow-up. The TXA group had a lower rate of myocardial infarction than did the placebo group (0.0% vs 4.9% at 84 months; P = 0.03).
Tranexamic acid significantly decreased postoperative bleeding and allogeneic transfusion in patients undergoing on-pump CABG. The 7-year follow-up suggested that the use of TXA was safe and might play a potential role in the prevention of long-term myocardial infarction.
关于氨甲环酸(TXA)的安全性评估仍然很少,特别是关于其对接受体外循环冠状动脉旁路移植术(CABG)的患者的长期结局的影响。我们假设 TXA 对围手术期出血和异体输血的影响及其对接受体外循环 CABG 的患者的长期临床结局的影响优于对照组。
在这项前瞻性、随机、安慰剂对照试验中,210 名接受原发性和孤立性体外循环 CABG 的患者被随机分配接受 TXA 或相应体积的生理盐水。随机分配的患者在出院后 1、3、5 和 7 年进行随访。最后,163 名患者完成了 7 年的随访。主要结局是异体红细胞(RBC)输血。还评估了长期死亡率和发病率。
与安慰剂相比,TXA 减少了异体 RBC 的需求,表现为输注量(4.20±4.06 比 6.25±4.86 单位;P<0.01)、暴露比(52.0%比 71.6%;P<0.01)和失血量(879.0±392.5 比 1154.0±582.8 毫升;P<0.01)。在 7 年的随访期间,除心肌梗死外,两组之间的死亡率或发病率没有显著差异。TXA 组的心肌梗死发生率低于安慰剂组(0.0%比 84 个月时的 4.9%;P=0.03)。
氨甲环酸显著减少了体外循环 CABG 患者的术后出血和异体输血。7 年随访表明,使用 TXA 是安全的,并且可能在预防长期心肌梗死方面发挥潜在作用。