Bernardi Víctor, Szarfer Jorge, Summay Gabriel, Mendiz Oscar, Sarmiento Ricardo, Alemparte Máximo Rodriguez, Gabay José, Berger Peter B
Clínica del Sol, Buenos Aires, Argentina.
Am J Cardiol. 2007 Feb 1;99(3):349-52. doi: 10.1016/j.amjcard.2006.08.034. Epub 2006 Dec 1.
The optimal duration of treatment with clopidogrel after percutaneous coronary intervention (PCI) with stent placement remains controversial. The Randomized Argentine Clopidogrel Stent (RACS) trial was a prospective, randomized, nonblinded study of 1,004 patients undergoing PCI who were randomized after successful bare metal stent placement to 30 versus 180 days of clopidogrel; all patients also received aspirin. Patients were eligible regardless of whether they had presented with ST-elevation myocardial infarction (MI), acute coronary syndrome, or stable angina. The primary end point was a composite of death, MI, and stroke at 180 days. Baseline clinical characteristics showed no differences between groups in terms of age, gender, history, risk factors, or incidence of diabetes; 72% presented with an acute coronary syndrome and 15% had MI as the indication for PCI. At hospital discharge and 30 days, when the 2 groups received the same treatment, there were no significant differences between groups in frequency of death, MI, or stroke. However, from 30 days to 6 months, patients assigned to 6 months of clopidogrel reached the primary end point of death, MI, and stroke less frequently (4.99% vs 1.74%, p = 0.010, relative risk decrease 65%). No significant between-group differences were found in frequency of total bleeding (0.64% vs 1.52%, p = 0.34) for the control and study groups. In conclusion, after successful placement of a bare metal stent in a coronary artery, patients treated with 6 months of clopidogrel showed a trend toward fewer adverse events compared with those treated for 30 days.
经皮冠状动脉介入治疗(PCI)并植入支架后,氯吡格雷的最佳治疗时长仍存在争议。阿根廷氯吡格雷支架随机试验(RACS)是一项针对1004例接受PCI治疗患者的前瞻性、随机、非盲研究,这些患者在成功植入裸金属支架后被随机分为接受30天或180天氯吡格雷治疗组;所有患者均同时服用阿司匹林。无论患者表现为ST段抬高型心肌梗死(MI)、急性冠状动脉综合征还是稳定型心绞痛,均符合入选标准。主要终点是180天时的死亡、MI和卒中复合终点。基线临床特征显示,两组在年龄、性别、病史、危险因素或糖尿病发病率方面无差异;72%的患者表现为急性冠状动脉综合征,15%的患者以MI作为PCI的指征。在出院时及30天时,两组接受相同治疗,死亡、MI或卒中发生率在两组间无显著差异。然而,在30天至6个月期间,接受6个月氯吡格雷治疗的患者达到死亡、MI和卒中主要终点的频率较低(4.99%对1.74%,p = 0.010,相对风险降低65%)。对照组和研究组在总出血发生率方面未发现显著组间差异(0.64%对1.52%,p = 0.34)。总之,在冠状动脉成功植入裸金属支架后,与接受30天治疗的患者相比,接受6个月氯吡格雷治疗的患者不良事件有减少趋势。