Division of Cardiac Surgery, Brigham & Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
J Thromb Thrombolysis. 2011 Oct;32(3):378-85. doi: 10.1007/s11239-011-0613-6.
We sought to assess the feasibility of comparing the efficacy and safety of fondaparinux versus heparin for prevention of graft failure and major CV events in patients undergoing coronary artery bypass grafting (CABG). Patients undergoing CABG were randomized to receive postoperative injections of fondaparinux or heparin in-hospital. After discharge, the fondaparinux group received fondaparinux and the heparin group received placebo injections for 30 days post surgery. Efficacy outcomes were graft failure, death, MI, and stroke at 30 days. Safety outcomes were bleeding, transfusion, and reoperation. 100 patients were recruited, 99 were randomized, 49 received fondaparinux and 50 received heparin. CT angiography was performed in 97% of patients. 188 grafts in the treatment group and 189 grafts in the heparin group were imaged. A similar proportion of patients treated with fondaparinux compared with heparin had at least one occluded graft (18.8% fondaparinux vs. 14.9% heparin, P = 0.62) and a similar number of grafts were occluded in each treatment group (all grafts: 4.8% vs. 4.8%, P = 0.99; saphenous vein grafts 4.2% vs. 4.2%, P = 0.98). There was no difference between treatment groups in death, MI, stroke, bleeding events, or reoperation. One in 10 patients undergoing CABG had at least one occluded graft at 30 days and one in 20 grafts is occluded by 30 days. Fondaparinux appears to be a safe alternative to heparin after CABG and it is feasible to conduct a definitive RCT using CT angiography to evaluate the effect of fondaparinux treatment on graft patency.
我们旨在评估比较依诺肝素与磺达肝癸钠预防冠状动脉旁路移植术（CABG）后移植物失败和主要心血管事件（CV）的疗效和安全性的可行性。接受 CABG 的患者随机接受术后依诺肝素或肝素住院治疗。出院后，依诺肝素组接受依诺肝素，肝素组接受术后 30 天安慰剂注射。主要疗效终点为术后 30 天的移植物失败、死亡、心肌梗死（MI）和卒中等事件。安全性终点为出血、输血和再次手术。共纳入 100 例患者，其中 99 例随机分组，49 例接受依诺肝素，50 例接受肝素。97%的患者进行了 CT 血管造影。治疗组 188 个移植物和肝素组 189 个移植物进行了成像。接受依诺肝素治疗的患者与接受肝素治疗的患者中至少有一个闭塞移植物的比例相似（依诺肝素组 18.8%，肝素组 14.9%，P=0.62），且每个治疗组的闭塞移植物数量相似（所有移植物：4.8%比 4.8%，P=0.99；隐静脉移植物：4.2%比 4.2%，P=0.98）。治疗组之间在死亡、MI、卒中等事件和出血或再次手术方面无差异。10 例接受 CABG 的患者中，至少有 1 例在 30 天时有闭塞移植物，20 个移植物中有 1 个在 30 天内闭塞。依诺肝素似乎是 CABG 后肝素的一种安全替代方案，使用 CT 血管造影进行一项关于依诺肝素治疗对移植物通畅性影响的确定性 RCT 是可行的。
