Kjekshus John, Dunselman Peter, Blideskog Malin, Eskilson Christina, Hjalmarson Ake, McMurray John V, Waagstein Finn, Wedel Hans, Wessman Peter, Wikstrand John
Department of Cardiology, Rikshospitalet University Hospital, University of Oslo, Sognsvannsveien 20, Oslo 0027, Norway.
Eur J Heart Fail. 2005 Oct;7(6):1059-69. doi: 10.1016/j.ejheart.2005.09.005.
Previous prospective outcome studies of statins have not provided any guidance on benefit-risk in patients with heart failure.
The primary objective is to determine whether rosuvastatin (10 mg) reduces the combined endpoint of cardiovascular mortality, non-fatal myocardial infarction or non-fatal stroke (time to first event). The first secondary endpoint is all-cause mortality.
CORONA is a randomized, double-blind, placebo-controlled trial. Briefly, men and women, aged > or =60 years with chronic symptomatic systolic heart failure of ischemic aetiology and ejection fraction < or =0.40 (NYHA class III and IV) or < or =0.35 (NYHA class II) were eligible if they were not using or in need of cholesterol lowering drugs.
Mean age was 73 years (n=5016; 24% women), with 37% in NYHA II and 62% in NYHA III, ejection fraction 0.31, total cholesterol 5.2 mmol/L. Sixty percent have a history of myocardial infarction, 63% hypertension, and 30% diabetes. Patients are well treated for heart failure with 90% on loop or thiazide diuretics, 42% aldosterone antagonists, 91% ACE inhibitor or AT-I blocker, 75% beta-blockers, and 32% digitalis.
CORONA is important for three main reasons: (1) A positive result is very important because of the high risk of the population studied, the increasing prevalence of elderly patients with chronic symptomatic systolic heart failure in our society, and the health economic issues involved. (2) If negative, new mechanistic questions about heart failure have to be raised. (3) If neutral we can avoid unnecessary polypharmacy.
先前关于他汀类药物的前瞻性结局研究未就心力衰竭患者的获益风险提供任何指导。
主要目标是确定瑞舒伐他汀（10毫克）是否能降低心血管死亡、非致死性心肌梗死或非致死性卒中的联合终点（首次事件发生时间）。首个次要终点是全因死亡率。
CORONA是一项随机、双盲、安慰剂对照试验。简而言之，年龄≥60岁、患有缺血性病因的慢性症状性收缩性心力衰竭且射血分数≤0.40（纽约心脏病协会III级和IV级）或≤0.35（纽约心脏病协会II级）的男性和女性，如果他们未使用或不需要降胆固醇药物，则符合入选标准。
平均年龄为73岁（n = 5016；24%为女性），纽约心脏病协会II级患者占37%，纽约心脏病协会III级患者占62%，射血分数为0.31，总胆固醇为5.2毫摩尔/升。60%的患者有心肌梗死病史，63%有高血压，30%有糖尿病。心力衰竭患者得到了良好治疗，90%的患者使用袢利尿剂或噻嗪类利尿剂，42%使用醛固酮拮抗剂，91%使用血管紧张素转换酶抑制剂或血管紧张素II受体拮抗剂，75%使用β受体阻滞剂，32%使用洋地黄。
CORONA试验具有重要意义，主要有三个原因：（1）鉴于所研究人群的高风险、我们社会中患有慢性症状性收缩性心力衰竭的老年患者患病率不断上升以及所涉及的卫生经济问题，阳性结果非常重要。（2）如果结果为阴性，则必须提出有关心力衰竭的新机制问题。（3）如果结果为中性，我们可以避免不必要的联合用药。
