Division of Cardiac Surgery, Québec Heart and Lung Institute, Québec City, Québec, Canada.
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
J Thorac Cardiovasc Surg. 2018 Jan;155(1):212-222.e2. doi: 10.1016/j.jtcvs.2017.06.039. Epub 2017 Jun 24.
In this 8 years' follow-up study, we evaluated the long-term outcomes of the addition of clopidogrel to aspirin during the first year after coronary artery bypass grafting, versus aspirin plus placebo, with respect to survival, major adverse cardiac, or major cerebrovascular events, including revascularization, functional status, graft patency, and native coronary artery disease progression.
In the initial Clopidogrel After Surgery for Coronary Artery Disease trial, 113 patients were randomized to receive either daily clopidogrel (n = 56) or placebo (n = 57), in addition to aspirin, in a double-blind fashion for 1 year after coronary artery bypass grafting. All patients were re-evaluated to collect long-term clinical data. Surviving patients with a glomerular filtration rate > 30 mL/min were asked to undergo a coronary computed tomography angiogram to evaluate the late saphenous vein graft patency and native coronary artery disease progression.
At a median follow-up of 7.6 years, survival rate was 85.5% ± 3.8% (P = .23 between the 2 groups). A trend toward enhanced freedom from all-cause death or major adverse cardiac or cerebrovascular events, including revascularization, was observed in the aspirin-clopidogrel group (P = .11). No difference in functional status or freedom from angina was observed between the 2 groups (P > .57). The long-term patency of saphenous vein graft was 89.11% in the aspirin-clopidogrel group versus 91.23% in the aspirin-placebo group (P = .79). A lower incidence of moderate to severe native disease progression was observed in the aspirin-clopidogrel group versus the aspirin-placebo group (7 out of 122 vs 13 out of 78 coronary segments that showed progression, respectively [odds ratio, 0.3 ± 0.2; 95% confidence interval, 0.1-0.8; P = .02]).
At 8 years' follow-up, the addition of clopidogrel to aspirin during the first year after coronary artery bypass grafting exhibited a lower incidence of moderate to severe progression of native coronary artery disease and a trend toward higher freedom from major adverse cardiac or cerebrovascular events, including revascularization, or death in the aspirin-clopidogrel group.
http://www.clinicaltrials.gov. Unique identifier: NCT00228423.
在这项为期 8 年的随访研究中,我们评估了在冠状动脉旁路移植术后的第一年中,加用氯吡格雷对比阿司匹林加安慰剂用于治疗的长期结果,主要终点为生存率、主要心脏不良事件或主要脑血管事件,包括血运重建、功能状态、移植物通畅性和原发性冠状动脉疾病进展。
在最初的《氯吡格雷在冠状动脉旁路移植术后的应用》研究中,113 例患者随机接受每日氯吡格雷(n=56)或安慰剂(n=57)治疗,均为双盲治疗,在冠状动脉旁路移植术后 1 年内加用阿司匹林。所有患者均进行了重新评估以收集长期临床数据。肾小球滤过率>30 mL/min 的存活患者被要求接受冠状动脉计算机断层血管造影术,以评估晚期大隐静脉移植物通畅性和原发性冠状动脉疾病进展情况。
中位随访 7.6 年后,生存率为 85.5%±3.8%(两组间 P=0.23)。阿司匹林-氯吡格雷组观察到全因死亡或主要心脏不良或脑血管事件(包括血运重建)的无事件生存率有提高的趋势(P=0.11)。两组间功能状态或无心绞痛的生存率无差异(P>0.57)。阿司匹林-氯吡格雷组的大隐静脉移植物通畅率为 89.11%,阿司匹林-安慰剂组为 91.23%(P=0.79)。阿司匹林-氯吡格雷组观察到中度至重度原发性疾病进展的发生率较低,阿司匹林-安慰剂组为 13 例(7 个节段)[比值比,0.3±0.2;95%置信区间,0.1-0.8;P=0.02]。
在 8 年的随访中,在冠状动脉旁路移植术后的第一年中加用氯吡格雷对比阿司匹林可降低原发性冠状动脉疾病的中度至重度进展发生率,并在阿司匹林-氯吡格雷组中观察到较高的无主要心脏不良或脑血管事件(包括血运重建)或死亡发生率的趋势。