Intensive LDL Cholesterol Targeting in Atherosclerotic Cardiovascular Disease.

Methods

In this open-label superiority trial conducted in South Korea, we randomly assigned patients with atherosclerotic cardiovascular disease in a 1:1 ratio to a target LDL cholesterol level of less than 55 mg per deciliter (1.4 mmol per liter) (intensive-targeting group) or less than 70 mg per deciliter (1.8 mmol per liter) (conventional-targeting group).

在这项在韩国进行的开放标签优势试验中，我们以1:1的比例随机分配动脉粥样硬化心血管疾病患者，目标低密度脂蛋白(LDL)胆固醇水平设定为小于55毫克/分升（1.4毫摩尔/升）（强化目标组）或小于70毫克/分升（1.8毫摩尔/升）（常规目标组）。

The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, any revascularization, or hospitalization for unstable angina at 3 years.

主要终点是3年内因心血管原因死亡、非致命性心肌梗死、非致命性中风、任何血管重建术或因不稳定性心绞痛住院的复合终点。

Safety was also assessed.

安全性也得到了评估。

Results

Of 3048 patients who underwent randomization, 1526 were assigned to the intensive-targeting group and 1522 to the conventional-targeting group.

在3048名接受随机分组的患者中，1526名被分配到强化靶向治疗组，1522名被分配到常规靶向治疗组。

The median follow-up was 3.0 years.

中位随访时间为3.0年。

The median LDL cholesterol level during the trial was 56 mg per deciliter (1.4 mmol per liter) in the intensive-targeting group and 66 mg per deciliter (1.7 mmol per liter) in the conventional-targeting group.

试验期间，强化目标组的中位低密度脂蛋白胆固醇水平为每分升56毫克（每升1.4毫摩尔），而常规目标组为每分升66毫克（每升1.7毫摩尔）。

A primary end-point event occurred in 100 patients (Kaplan-Meier estimate of cumulative incidence, 6.6%) in the intensive-targeting group and in 147 patients (Kaplan-Meier estimate of cumulative incidence, 9.7%) in the conventional-targeting group (hazard ratio, 0.67; 95% confidence interval, 0.52 to 0.86; P = 0.002).

在强化目标组中，有100名患者发生了主要终点事件（Kaplan-Meier累积发生率估计为6.6%），而在常规目标组中，有147名患者发生了主要终点事件（Kaplan-Meier累积发生率估计为9.7%）（风险比，0.67；95%置信区间，0.52至0.86；P = 0.002）。

The incidenceof prespecified safety end points was similar in the two trial groups, except for a lower incidenceof creatinine elevation in the intensive-targeting group.

在两项试验组中，预定的安全终点发生率相似，除了强化目标组中肌酐升高的发生率较低。

Conclusions

Among patients with atherosclerotic cardiovascular disease, targeting an LDL cholesterol level of less than 55 mg per deciliter resulted in a lower risk of cardiovascular events at 3 years than targeting a level of less than 70 mg per deciliter.

在动脉粥样硬化性心血管疾病患者中，针对低密度脂蛋白胆固醇水平小于55毫克/分升的目标，与小于70毫克/分升的目标相比，3年内心血管事件的风险更低。

(Funded by the Cardiovascular Research Center and Yuhan; Ez-PAVE ClinicalTrials.gov number, NCT04626973.).

(由心血管研究中心和Yuhan资助; Ez-PAVE ClinicalTrials.gov编号, NCT04626973.)。