Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome The SECURE-PCI Randomized Clinical Trial
Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome The SECURE-PCI Randomized Clinical Trial
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DOI：
10.1001/jama.2018.2444
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发表时间：
2018-04-03
影响因子：
120.7
通讯作者：
Lopes, Renato Delascio
中科院分区：
文献类型：
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作者：
Berwanger, Otavio;Santucci, Eliana Vieira;Lopes, Renato Delascio
重要性负荷剂量的他汀类药物对急性冠脉综合征（ACS）和有计划的侵入性管理患者临床结局的影响尚不确定。目的确定围手术期负荷剂量的阿托伐他汀是否减少ACS和有计划的侵入性管理患者的30天主要不良心血管事件（MACE）。在巴西53家研究中心进行的随机临床试验，纳入4191例ACS患者，经冠状动脉造影评估，如果解剖学可行，则继续进行经皮冠状动脉介入治疗（PCI）。入组时间为2012年4月18日至2017年10月6日。干预患者在计划的PCI术前和术后24小时随机接受2种负荷剂量的80 mg阿托伐他汀（n = 2087）或匹配的安慰剂（n = 2104）。所有患者在第二剂研究药物后24小时开始接受40 mg阿托伐他汀治疗30天。主要结局和指标主要结局是MACE，定义为30天内全因死亡、心肌梗死、卒中和计划外冠状动脉血运重建的复合物。（平均年龄，61.8 [SD，11.5]岁; 1085例女性[25.9%]）入组，4163例（99.3%）完成了30天随访。共有2710例（64.7%）接受了PCI，333例（8%）接受了冠状动脉旁路移植术，1144例（27.3%）接受了专门的医疗管理。第30天时，阿托伐他汀组130例患者（6.2%）和安慰剂组149例患者（7.1%）发生MACE（绝对差异，0.85%[95% CI，-0.70%至2.41%];风险比，0.88; 95% CI，0.69-1.11; P = 0.27）。没有肝衰竭的情况下，报告了3例横纹肌溶解症在安慰剂组（0.1%）和0在阿托伐他汀group.CONCLUSIONS和RELEVANCE ACS患者和计划的侵入性管理与PCI，围手术期负荷剂量阿托伐他汀并没有减少30天的MACE率。这些发现不支持ACS患者中常规使用负荷剂量的阿托伐他汀和预期的侵入性治疗。
IMPORTANCE The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain.OBJECTIVE To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management.DESIGN, SETTING, AND PARTICIPANTS Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017.INTERVENTIONS Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication.MAIN OUTCOMES AND MEASURES The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 daysRESULTS Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85%[95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P =.27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group.CONCLUSIONS AND RELEVANCE Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management.