Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention - A randomized controlled trial
Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention - A randomized controlled trial
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DOI：
10.1001/jama.287.24.3215
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发表时间：
2002-06-26
影响因子：
120.7
通讯作者：
Meier, B
中科院分区：
文献类型：
--
作者：
Serruys, PWJC;de Feyter, P;Meier, B
经皮冠状动脉介入治疗（PCI）与缺血性症状的极好短期改善相关，但只有五分之三的PCI患者在5年和三分之一的患者在10年没有主要不良心脏事件（MACE）。目的探讨氟伐他汀治疗是否能降低PCI患者的MACE。随机、双盲、安慰剂对照试验在欧洲、加拿大和巴西的77个转诊中心进行。在1996年4月至1998年10月期间招募的1677例患者（年龄18-80岁），在第一次PCI成功完成后出现稳定或不稳定心绞痛或无症状缺血，基线总胆固醇水平在135 - 270 mg/dL （3.5-7.0 mmol/L）之间，空腹甘油三酯水平低于400 mg/dL （4.5 mmol/L）。干预措施患者在出院时被随机分配接受氟伐他汀80mg /d （n = 844）或匹配安慰剂（n = 833）治疗3 - 4年。主要结局指标：治疗组和安慰剂组无MACE的生存时间，定义为心源性死亡、非致死性心肌梗死或再干预手术。结果PCI至首次给药的中位时间为2.0天，中位随访时间为3.9年。氟伐他汀组无mace生存时间明显延长（P= 0.01）。氟伐他汀组844例患者中有181例（21.4%）发生MACE，安慰剂组833例患者中有222例（26.7%）发生MACE（相对危险度[RR]， 0.78； 95%可信区间[CI]， 0.64-0.95； P= 0.01）。该结果与基线总胆固醇水平无关（高于[RR， 0.76; 95% CI, 0.56-1.041]，低于[RR， 0.77; 95% CI, 0.57-1.02]）。在亚组分析中，与安慰剂组相比，氟伐他汀组糖尿病患者（n=202； RR, 0.53; 95% CI, 0.29 -0.97； P= 0.04）和多血管疾病患者（n= 614； RR, 0.66; 95% CI, 0.48-0.91； P= 0.01）发生MACE的风险降低。氟伐他汀组中没有肌酸磷酸激酶升高超过正常或横纹肌溶解上限10倍的病例。结论氟伐他汀治疗首次成功行平均胆固醇水平PCI的患者可显著降低主要心脏不良事件的发生风险。
Context Percutaneous coronary intervention (PCI) is associated with excellent short-term improvements in ischemic symptoms, yet only three fifths of PCI patients at 5 years and one third of patients at 10 years remain free of major adverse cardiac events (MACE).Objective To determine whether treatment with fluvastatin reduces MACE in patients who have undergone PCI.Design and Setting Randomized, double-blind, placebo-controlled trial conducted at 77 referral centers in Europe, Canada, and Brazil.Patients A total of 1677 patients (aged 18-80 years) recruited between April 1996 and October 1998 with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL (3.5-7.0 mmol/L), with fasting triglyceride levels of less than 400 mg/dL (4.5 mmol/L).Interventions Patients were randomly assigned to receive treatment with fluvastatin, 80 mg/d (n = 844), or matching placebo (n = 833) at hospital discharge for 3 to 4 years.Main Outcome Measure Survival time free of MACE, defined as cardiac death, nonfatal myocardial infarction, or reintervention procedure, compared between the treatment and placebo groups.Results Median time between PCI and first dose of study medication was 2.0 days, and median follow-up was 3.9 years. MACE-free survival time was significantly longer in the fluvastatin group (P=.01). One hundred eighty-one (21.4%) of 844 patients in the fluvastatin group and 222 (26.7%) of 833 patients in the placebo group had at least 1 MACE (relative risk [RR], 0.78; 95% confidence interval [CI], 0.64-0.95; P=.01). This result was independent of baseline total cholesterol levels (above [RR, 0.76; 95% CI, 0.56-1.041 vs below [RR, 0.77; 95% CI, 0.57-1.02] the median). In subgroup analysis, the risk of MACE was reduced in patients with diabetes (n=202; RR, 0.53; 95% CI, 0,29-0.97; P=.04) and in those with multivessel disease (n = 614; RR, 0.66; 95% CI, 0.48-0.91; P=.01) who received fluvastatin compared with those who received placebo. There were no instances of creatine phosphokinase elevations 10 or more times the upper limit of normal or rhabdomyolysis in the fluvastatin group.Conclusion Fluvastatin treatment in patients with average cholesterol levels undergoing their first successful PCI significantly reduces the risk of major adverse cardiac events.