Population Health Research Institute, McMaster University, Hamilton, ON, Canada.
N Engl J Med. 2011 Mar 10;364(10):928-38. doi: 10.1056/NEJMoa1008816.
The risk of cardiovascular events among patients with atrial fibrillation is high. We evaluated whether irbesartan, an angiotensin-receptor blocker, would reduce this risk.
We randomly assigned patients with a history of risk factors for stroke and a systolic blood pressure of at least 110 mm Hg to receive either irbesartan at a target dose of 300 mg once daily or double-blind placebo. These patients were already enrolled in one of two trials (of clopidogrel plus aspirin versus aspirin alone or versus oral anticoagulants). The first coprimary outcome was stroke, myocardial infarction, or death from vascular causes; the second was this composite outcome plus hospitalization for heart failure.
A total of 9016 patients were enrolled and followed for a mean of 4.1 years. The mean reduction in systolic blood pressure was 2.9 mm Hg greater in the irbesartan group than in the placebo group, and the mean reduction in diastolic blood pressure was 1.9 mm Hg greater. The first coprimary outcome occurred at a rate of 5.4% per 100 person-years in both groups (hazard ratio with irbesartan, 0.99; 95% confidence interval [CI], 0.91 to 1.08; P=0.85). The second coprimary outcome occurred at a rate of 7.3% per 100 person-years among patients receiving irbesartan and 7.7% per 100 person-years among patients receiving placebo (hazard ratio, 0.94; 95% CI, 0.87 to 1.02; P=0.12). The rates of first hospitalization for heart failure (a prespecified secondary outcome) were 2.7% per 100 person-years among patients receiving irbesartan and 3.2% per 100 person-years among patients receiving placebo (hazard ratio, 0.86; 95% CI, 0.76 to 0.98). Among patients who were in sinus rhythm at baseline, there was no benefit of irbesartan in preventing hospitalization for atrial fibrillation or atrial fibrillation recorded on 12-lead electrocardiography, nor was there a benefit in a subgroup that underwent transtelephonic monitoring. More patients in the irbesartan group than in the placebo group had symptomatic hypotension (127 vs. 64) and renal dysfunction (43 vs. 24).
Irbesartan did not reduce cardiovascular events in patients with atrial fibrillation. (Funded by Bristol-Myers Squibb and Sanofi-Aventis; ClinicalTrials.gov number, NCT00249795.).
心房颤动患者发生心血管事件的风险较高。我们评估了血管紧张素受体阻滞剂厄贝沙坦是否会降低这种风险。
我们将有中风危险因素且收缩压至少为 110mmHg 的患者随机分配，接受目标剂量为 300mg 的厄贝沙坦或双盲安慰剂治疗。这些患者已经参加了两项试验中的一项（氯吡格雷加阿司匹林与阿司匹林或口服抗凝剂）。主要复合终点为卒中、心肌梗死或血管原因导致的死亡；次要复合终点为该复合终点加上心力衰竭住院。
共纳入 9016 例患者，平均随访 4.1 年。厄贝沙坦组的收缩压平均降低 2.9mmHg，舒张压平均降低 1.9mmHg，均优于安慰剂组。两组的主要复合终点发生率均为每 100 人年 5.4%（厄贝沙坦组的危险比为 0.99；95%置信区间为 0.91 至 1.08；P=0.85）。厄贝沙坦组和安慰剂组因心力衰竭首次住院的发生率分别为每 100 人年 7.3%和 7.7%（危险比为 0.94；95%置信区间为 0.87 至 1.02；P=0.12）。在预先设定的次要终点中，因心力衰竭首次住院的发生率分别为厄贝沙坦组每 100 人年 2.7%和安慰剂组每 100 人年 3.2%（危险比为 0.86；95%置信区间为 0.76 至 0.98）。在基线时窦性心律的患者中，厄贝沙坦组在预防心房颤动住院或 12 导联心电图记录的心房颤动方面没有获益，在接受远程心电图监测的亚组中也没有获益。厄贝沙坦组出现症状性低血压（127 例与 64 例）和肾功能不全（43 例与 24 例）的患者多于安慰剂组。
在心房颤动患者中，厄贝沙坦并未降低心血管事件的发生。（由 Bristol-Myers Squibb 和 Sanofi-Aventis 资助；ClinicalTrials.gov 编号，NCT00249795。）
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