摘要
主动脉瓣狭窄和动脉粥样硬化性疾病有很多共同的危险因素,尤其是高胆固醇血症。在组织学上,病变的瓣膜似乎具有与动脉粥样硬化斑块非常相似的炎症区域。降脂治疗对主动脉瓣狭窄(AS)进展的影响尚不清楚,而且尚没有相关的随机治疗试验评价这类患者中的心血管发病率和死亡率。SEAS(辛伐他汀和依泽替米贝应用于主动脉瓣狭窄)是一项随机、双盲、安慰剂对照的多中心研究,旨在在至少4年的研究期内观察辛伐他汀40m g/d或依泽替米贝10m g/d的降脂治疗对跨瓣射血峰值速度为2.5～4.0m/s的无症状AS患者的作用。主要的疗效指标为主动脉瓣手术和缺血性血管事件,包括心血管疾病死亡;次要终点为利用超声心动图观察的对AS进展的影响。
Aortic valve stenosis and atherosclerotic disease have several risk factors in common, in particular, hypercholesterolemia. Histologically, the diseased valves appear to have areas of inflammation much like atherosclerotic plaques. The effect of lipid-lowering therapy on the progression of aortic stenosis(AS) is unclear, and there are no randomized treatment trials evaluating cardiovascular morbidity and mortality in such patients. The Simvastatin and Ezetimibe in Aortic Stenosis(SEAS) Study is a randomized, double-blind, placebo-controlled, multicenter study of a minimum 4 years’ duration investigating the effect of lipid lowering with ezetimibe/simvastatin 10/40 mg/day in patients with asymptomatic AS with peak transvalvular jet velocity 2.5 to 4.0 m/s. Primary efficacy variables include aortic valve surgery and ischemic vascular events, including cardiovascular mortality, and second, the effect on echocardiographically evaluated progression of AS. The SEAS Study randomly assigned 1,873 patients(age 68± 10 years, 39% women, mean transaortic maximum velocity 3.1± 0.5 m/s) from 173 sites. Other baseline characteristics were mean blood pressure of 145± 20/82± 10 mm Hg(51% hypertensive); 55% were current or previous smokers; and most were overweight(mean body mass index 26.9 kg/m2). At baseline, mean total cholesterol was 5.7± 1.0 mmol/L(222 mg/dl), low-density lipoprotein cholesterol was 3.6± 0.9 mmol/L(139 mg/dl), high-density lipoprotein cholesterol was 1.5± 0.4 mmol/L(58 mg/dl), and triglycerides were 1.4± 0.7 mmol/L(126 mg/dl). The SEAS Study is the largest randomized trial to date in patients with AS and will allow determination of the prognostic value of aggressive lipid lowering in such patients.
