Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation
Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation
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DOI：
10.1001/jama.297.2.joc60179
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发表时间：
2007-01-10
影响因子：
120.7
通讯作者：
Califf, Robert M.
中科院分区：
文献类型：
--
作者：
Eisenstein, Eric L.;Anstrom, Kevin J.;Califf, Robert M.
最近对药物洗脱冠状动脉内支架的研究表明，目前的抗血小板方案可能不足以预防晚期支架血栓形成。目的探讨氯吡格雷的使用与接受药物洗脱支架（DES）和裸金属支架（BMS）治疗冠状动脉疾病患者长期临床结局的关系。设计、环境和患者：一项观察性研究，在2000年1月1日至2005年7月31日期间，在杜克心脏中心（位于北卡罗来纳州达勒姆的三级医疗中心）连续接受冠状动脉内支架的患者，并在6、12和24个月至2006年9月7日进行随访。研究人群包括4666例最初接受经皮冠状动脉介入治疗的BMS患者（n = 3165）或DES患者（n = 1501）。在6个月和12个月的随访中，对无事件（无死亡、心肌梗死[MI]或血运重建术）的患者进行了里程碑式的分析。此时，患者根据支架类型和自我报告的氯吡格雷使用情况分为4组：有氯吡格雷的DES组、没有氯吡格雷的DES组、有氯吡格雷的BMS组和没有氯吡格雷的BMS组。主要结局指标：24个月随访时死亡、非致死性心肌梗死以及死亡或心肌梗死的综合情况。结果在6个月无事件发生的DES患者中（637例使用氯吡格雷，579例不使用氯吡格雷），使用氯吡格雷是24个月调整死亡率（2.0%与5.3%，差异为-3.3%;95% CI, -6.3%至-0.3%,P = 0.03）和死亡或心肌梗死（3.1%对7.2%，差异为-4.1%;95% CI, -7.6%至-0.6%,P = 0.02）较低的显著预测因子。然而，在BMS患者（417例使用氯吡格雷和1976例不使用氯吡格雷）中，死亡（3.7% vs 4.5%；差异-0.7%;95% CI, -2.9%至1.4%;P = 0.50）和死亡或心肌梗死（5.5% vs 6.0%；差异-0.5%;95% CI, -3.2%至2.2%;P = 0.70）没有差异。在12个月无事件发生的DES患者中（252例使用氯吡格雷，276例不使用氯吡格雷），使用氯吡格雷继续预测24个月时较低的死亡率（0% vs 3.5%；差异-3.5%;95% CI, -5.9%至-1.1%;P = 0.004）和死亡或心肌梗死（0% vs 4.5%；差异-4.5%;95% CI, -7.1%至-1.9%;P < 0.001）。然而，在BMS患者（346例使用氯吡格雷，1644例不使用氯吡格雷）中，死亡（3.3% vs 2.7%；差异为0.6%;95% CI, -1.5%至2.8%;P = 0.57）和死亡或心肌梗死（4.7% vs 3.6%；差异为1.0%;95% CI, -1.6%至3.6%;P = 0.44）仍然没有差异。结论：在DES患者中延长氯吡格雷的使用可能与死亡、死亡或心肌梗死的风险降低有关。然而，氯吡格雷的适当使用时间只能在大规模随机临床试验的背景下确定。
Context Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis.Objective To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) and bare-metal stents (BMS) for treatment of coronary artery disease.Design, Setting, and Patients An observational study examining consecutive patients receiving intracoronary stents at Duke Heart Center, a tertiary care medical center in Durham, NC, between January 1, 2000, and July 31, 2005, with follow-up contact at 6, 12, and 24 months through September 7, 2006. Study population included 4666 patients undergoing initial percutaneous coronary intervention with BMS (n = 3165) or DES (n = 1501). Landmark analyses were performed among patients who were event-free (no death, myocardial infarction [MI], or revascularization) at 6- and 12-month follow-up. At these points, patients were divided into 4 groups based on stent type and self-reported clopidogrel use: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel.Main Outcome Measures Death, nonfatal MI, and the composite of death or MI at 24-month follow-up.Results Among patients with DES who were event-free at 6 months (637 with and 579 without clopidogrel), clopidogrel use was a significant predictor of lower adjusted rates of death (2.0% with vs 5.3% without; difference, -3.3%; 95% CI, -6.3% to -0.3%; P = .03) and death or MI (3.1% vs 7.2%; difference, -4.1%; 95% CI, -7.6% to -0.6%; P = .02) at 24 months. However, among patients with BMS (417 with and 1976 without clopidogrel), there were no differences in death (3.7% vs 4.5%; difference, -0.7%; 95% CI, -2.9% to 1.4%; P = .50) and death or MI (5.5% vs 6.0%; difference, -0.5%; 95% CI, -3.2% to 2.2%; P = .70). Among patients with DES who were event-free at 12 months (252 with and 276 without clopidogrel), clopidogrel use continued to predict lower rates of death (0% vs 3.5%; difference, -3.5%; 95% CI, -5.9% to -1.1%; P = .004) and death or MI (0% vs 4.5%; difference, -4.5%; 95% CI, -7.1% to -1.9%; P < .001) at 24 months. However, among patients with BMS (346 with and 1644 without clopidogrel), there continued to be no differences in death (3.3% vs 2.7%; difference, 0.6%; 95% CI, -1.5% to 2.8%; P = .57) and death or MI (4.7% vs 3.6%; difference, 1.0%; 95% CI, -1.6% to 3.6%; P = .44).Conclusions The extended use of clopidogrel in patients with DES may be associated with a reduced risk for death and death or MI. However, the appropriate duration for clopidogrel administration can only be determined within the context of a large-scale randomized clinical trial.