Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis
Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis
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DOI：
10.1056/nejmoa0804602
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发表时间：
2008-09-25
影响因子：
158.5
通讯作者：
Willenheimer, Ronnie
中科院分区：
文献类型：
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作者：
Rossebo, Anne B.;Pedersen, Terje R.;Willenheimer, Ronnie
背景：高脂血症被认为是主动脉瓣狭窄的危险因素，但降脂研究的结果相互矛盾。方法：我们进行了一项随机、双盲试验，纳入了 1873 名轻至中度、无症状主动脉瓣狭窄患者。患者每天接受 40 毫克辛伐他汀加 10 毫克依折麦布或安慰剂。主要结局是主要心血管事件的综合，包括心血管原因死亡、主动脉瓣置换术、非致命性心肌梗死、不稳定心绞痛住院、心力衰竭、冠状动脉旁路移植术、经皮冠状动脉介入治疗和非出血性中风。次要结局是与主动脉瓣狭窄和缺血性心血管事件相关的事件。 结果：在中位随访 52.2 个月期间，主要结局发生在辛伐他汀-依折麦布组的 333 名患者（35.3%）和安慰剂组的 355 名患者（38.2%）（辛伐他汀-依折麦布组的风险比为 0.96；95%）置信区间 [CI]，0.83 至 1.12；P=0.59）。辛伐他汀-依折麦布组的 267 名患者（28.3%）和安慰剂组的 278 名患者（29.9%）进行了主动脉瓣置换术（风险比，1.00；95% CI，0.84 至 1.18；P=0.97）。辛伐他汀-依折麦布组（148 名患者）发生缺血性心血管事件的患者数量少于安慰剂组（187 名患者）（风险比为 0.78；95% CI，0.63 至 0.97；P=0.02），主要是因为接受冠状动脉旁路移植术的患者数量较少。辛伐他汀-依折麦布组的癌症发生率更高（105 vs. 70，P=0.01）。结论：辛伐他汀和依折麦布并没有减少主动脉瓣狭窄患者主动脉瓣事件和缺血事件的复合结果。这种治疗降低了缺血性心血管事件的发生率，但没有降低与主动脉瓣狭窄相关的事件的发生率。 （ClinicalTrials.gov 编号，NCT00092677。）。
Background: Hyperlipidemia has been suggested as a risk factor for stenosis of the aortic valve, but lipid-lowering studies have had conflicting results.Methods: We conducted a randomized, double-blind trial involving 1873 patients with mild-to-moderate, asymptomatic aortic stenosis. The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily. The primary outcome was a composite of major cardiovascular events, including death from cardiovascular causes, aortic-valve replacement, nonfatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary-artery bypass grafting, percutaneous coronary intervention, and nonhemorrhagic stroke. Secondary outcomes were events related to aortic-valve stenosis and ischemic cardiovascular events.Results: During a median follow-up of 52.2 months, the primary outcome occurred in 333 patients (35.3%) in the simvastatin-ezetimibe group and in 355 patients (38.2%) in the placebo group (hazard ratio in the simvastatin-ezetimibe group, 0.96; 95% confidence interval [CI], 0.83 to 1.12; P=0.59). Aortic-valve replacement was performed in 267 patients (28.3%) in the simvastatin-ezetimibe group and in 278 patients (29.9%) in the placebo group (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; P=0.97). Fewer patients had ischemic cardiovascular events in the simvastatin-ezetimibe group (148 patients) than in the placebo group (187 patients) (hazard ratio, 0.78; 95% CI, 0.63 to 0.97; P=0.02), mainly because of the smaller number of patients who underwent coronary-artery bypass grafting. Cancer occurred more frequently in the simvastatin-ezetimibe group (105 vs. 70, P=0.01).Conclusions: Simvastatin and ezetimibe did not reduce the composite outcome of combined aortic-valve events and ischemic events in patients with aortic stenosis. Such therapy reduced the incidence of ischemic cardiovascular events but not events related to aortic-valve stenosis. (ClinicalTrials.gov number, NCT00092677.).