本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2400969

摘要内容如下：

背景

急性心肌梗死后心血管事件频繁复发，低胆固醇流出（由载脂蛋白A1介导的过程，载脂蛋白A1是高密度脂蛋白中的主要蛋白）与心血管事件风险增加相关。CSL112是来源于血浆的人载脂蛋白A1，其增加胆固醇流出能力。输注CSL112是否可以降低急性心肌梗死后心血管事件复发的风险尚不清楚。

方法

我们进行了一项国际性、双盲、安慰剂对照试验，纳入了具有急性心肌梗死、多支冠状动脉疾病和其他心血管危险因素的患者。患者被随机分配接受每周4次的6克CSL112或匹配的安慰剂输注，第一次输注在急性心肌梗死的第一次医疗接触后5天内进行。主要终点是通过90天随访随机分组的心肌梗死、卒中或心血管原因死亡的复合终点。

结果

试验共纳入18，219名患者（CSL112组9112名，安慰剂组9107名）。在90天的随访中，两组的主要终点事件风险无显著差异（CSL112组439例[4.8%]，安慰剂组472例[5.2%]；风险比为0.93；95%置信区间[CI]，0.81至1.05；P=0.24），在180天的随访中（622名患者[6.9%]对683名患者[7.6%]；风险比为0.91；95%CI，0.81至1.01），或在365天随访时（885例患者[9.8%]对944例患者[10.5%]；风险比为0.93；95%置信区间，0.85至1.02）。两组患者发生不良事件的百分比相似；CSL112组报告的超敏事件数量较高。

结论

在患有急性心肌梗死、多支冠状动脉疾病和其他心血管危险因素的患者中，在90天内，与安慰剂相比，每周4次输注CSL112并不能降低心肌梗死、中风或心血管原因死亡的风险。（由CSL Behring资助；AEGIS-II ClinicalTrials.gov编号，NCT03473223。）

英文原文如下：

Abstracts

BACKGROUND  Cardiovascular events frequently recur after acute myocardial infarction, and low cholesterol efflux - a process mediated by apolipoprotein A1, which is the main protein in high-density lipoprotein - has been associated with an increased risk of cardiovascular events. CSL112 is human apolipoprotein A1 derived from plasma that increases cholesterol efflux capacity. Whether infusions of CSL112 can reduce the risk of recurrent cardiovascular events after acute myocardial infarction is unclear.

METHODS  We conducted an international, double-blind, placebo-controlled trial involving patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors. Patients were randomly assigned to receive either four weekly infusions of 6 g of CSL112 or matching placebo, with the first infusion administered within 5 days after the first medical contact for the acute myocardial infarction. The primary end point was a composite of myocardial infarction, stroke, or death from cardiovascular causes from randomization through 90 days of follow-up.

RESULTS  A total of 18,219 patients were included in the trial (9112 in the CSL112 group and 9107 in the placebo group). There was no significant difference between the groups in the risk of a primary end-point event at 90 days of follow-up (439 patients [4.8%] in the CSL112 group vs. 472 patients [5.2%] in the placebo group; hazard ratio, 0.93; 95% confidence interval [CI], 0.81 to 1.05; P = 0.24), at 180 days of follow-up (622 patients [6.9%] vs. 683 patients [7.6%]; hazard ratio, 0.91; 95% CI, 0.81 to 1.01), or at 365 days of follow-up (885 patients [9.8%] vs. 944 patients [10.5%]; hazard ratio, 0.93; 95% CI, 0.85 to 1.02). The percentage of patients with adverse events was similar in the two groups; a higher number of hypersensitivity events was reported in the CSL112 group.

CONCLUSIONS  Among patients with acute myocardial infarction, multivessel coronary artery disease, and additional cardiovascular risk factors, four weekly infusions of CSL112 did not result in a lower risk of myocardial infarction, stroke, or death from cardiovascular causes than placebo through 90 days. (Funded by CSL Behring; AEGIS-II ClinicalTrials.gov number, NCT03473223.).

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