Department of Cardiac Surgery, Rambam Health Care Campus, Haifa, Israel.
J Thorac Cardiovasc Surg. 2013 Jan;145(1):243-8. doi: 10.1016/j.jtcvs.2012.09.032. Epub 2012 Oct 13.
Cardiac surgery patients are treated with antifibrinolytic agents to reduce intra- and postoperative bleeding. Until 2007, lysine analogues (aminocaproic acid and tranexamic acid) and serine protease inhibitors (aprotinin) were recommended. In 2008, the U.S. Food and Drug Administration prohibited aprotinin use because of associated postoperative complications, including cerebrovascular accidents and renal failure. This work aimed at reevaluating the efficacy and safety of aprotinin versus tranexamic acid in patients undergoing elective coronary artery bypass surgery.
Two groups were enrolled in this study. Group A (n = 256), operated from January 2005 to August 2007, was treated with the half-Hammersmith aprotinin regime whereas group B (n = 104), operated after 2008, was treated with the full-dose tranexamic acid regime. All patients were of low-risk profile, and underwent an elective, on-pump coronary artery bypass surgery. The main outcome measures were safety, assessed in relation to thrombosis-related cardiac, cerebral, and renal events; and efficacy, investigated in terms of postoperative bleeding and infusions of blood products.
Postoperatively, group B demonstrated greater bleeding during the operative and first postoperative days, and total bleeding (P values ≤ .001); a greater requirement of blood and/or blood products infusions (P = .024); higher postoperative acute renal failure rates (P = .028); lower platelet count (P = .002); and a higher postoperative increase in troponin levels (P < .0001).
Among low-risk patients undergoing coronary artery bypass surgery, the half-Hammersmith aprotinin-based antifibrinolytic management proved to be more efficacious in terms of bleeding and consumption of blood products, with no evidence of associated increased rates of postoperative complications. Accordingly, the usage of aprotinin should be reconsidered for treatment among cohorts of low-risk cardiac patients.
心脏手术患者使用抗纤维蛋白溶解剂来减少术中及术后出血。直到 2007 年,赖氨酸类似物(氨甲环酸和氨甲环酸)和丝氨酸蛋白酶抑制剂(抑肽酶)被推荐使用。2008 年,美国食品和药物管理局因术后并发症(包括脑血管意外和肾功能衰竭)而禁止使用抑肽酶。本研究旨在重新评估心脏选择性冠状动脉旁路移植术患者使用抑肽酶与氨甲环酸的疗效和安全性。
本研究纳入了两组患者。A 组(n=256)于 2005 年 1 月至 2007 年 8 月接受半哈默史密斯抑肽酶治疗,B 组(n=104)于 2008 年后接受全剂量氨甲环酸治疗。所有患者均为低危患者,接受选择性、体外循环冠状动脉旁路移植术。主要观察指标为安全性,评估血栓相关的心脏、大脑和肾脏事件;和疗效,通过术后出血和血液制品输注来研究。
术后 B 组第 1 天和术后第 1 天的出血量更大,总出血量更多(P 值均≤.001);需要输注更多的血液或血液制品(P=0.024);术后急性肾功能衰竭发生率更高(P=0.028);血小板计数较低(P=0.002);以及术后肌钙蛋白水平升高(P<0.0001)。
在接受冠状动脉旁路移植术的低危患者中,半哈默史密斯抑肽酶基于抗纤维蛋白溶解的管理在出血和血液制品消耗方面更有效,且无术后并发症发生率增加的证据。因此,对于低危心脏患者,应重新考虑使用抑肽酶进行治疗。