Triple Versus Dual Lipid-Lowering Therapy in Acute Coronary Syndrome: The ES-BempedACS Randomized Clinical Trial.

Earlier intensive strategies based on a combination of lipid-lowering therapies (LLTs) could be useful from the onset of ACS.

基于联合降脂治疗（LLTs）的早期强化策略可能从ACS发病初期就非常有用。

However, the role of bempedoic acid in ACS, particularly when combined with high-intensity statins and ezetimibe, remains uncertain.

然而，苯普酸在急性冠状动脉综合征（ACS）中的作用，特别是当与高强度他汀类药物和依泽替米布联合使用时，仍然不确定。

The aim of ES-BempedACS (Efficacy and Security of Bempedoic Acid in Acute Coronary Syndrome) was to compare the efficacy and safety of triple LLT (high-dose, high-intensity statin+ezetimibe+bempedoic acid) versus standard of care (high-dose, high-intensity statin+ezetimibe) after ACS.

ES-BempedACS（苯普酸在急性冠状动脉综合征中的疗效和安全性）旨在比较ACS后三重低密度脂蛋白治疗（高强度他汀类药物+依泽替米布+苯普酸）与标准治疗（高强度他汀类药物+依泽替米布）的有效性和安全性。

Methods

ES-BempedACS is a multicenter, independent, pragmatic, prospective, randomized, open, blinded end point controlled trial conducted in 12 Spanish hospitals between November 2023 and October 2024.

ES-BempedACS 是一项在 2023 年 11 月至 2024 年 10 月期间在 12 家西班牙医院进行的多中心、独立、实用、前瞻性、随机、开放、盲终点对照试验。

The primary end point was the proportion of patients achieving LDL-C <55 mg/dL (<1.4 mmol/L) at 8 weeks after ACS, comparing triple LLT with standard of care.

主要终点是 ACS 后 8 周内达到 LDL-C <55 mg/dL (<1.4 mmol/L) 的患者比例，比较三重低脂治疗与常规护理。

Results

A total of 206 patients (59.5±10.9 years of age [mean±SD]; 21.4% women) were randomized within the first 72 hours of ACS to triple LLT or standard therapy of high-intensity statin+ezetimibe (ie, dual LLT).

共有206名患者（平均年龄59.5±10.9岁[平均值±标准差]；21.4%为女性）在ACS发病后72小时内被随机分配至三联降脂治疗组或高强度他汀+依折麦布的标准治疗组（即双重降脂治疗）。

The baseline LDL-C level was 133.6±28.8 mg/dL.

基线低密度脂蛋白胆固醇（LDL-C）水平为133.6±28.8 mg/dL。

After 8 weeks, the LDL-C level was reduced to <55 mg/dL in 59.4% of patients in the triple LLT group compared with 53.1% in the control group (dual LLT; P=0.376).

8周后，三重降脂治疗组中有59.4%的患者的LDL-C水平降低至<55 mg/dL，而对照组（双重降脂治疗）中这一比例为53.1%（P=0.376）。

The percentage change in LDL-C level was 57.5±17.8% and 56.9±18.5% in the triple and dual LLT groups, respectively (P=0.823).

LDL-C水平的百分比变化分别为三重降脂治疗组的57.5±17.8%和双重降脂治疗组的56.9±18.5%（P=0.823）。

Triple versus dual LLT showed similar results in reduction of non-high-density lipoprotein cholesterol levels (49.0±25.4 in triple LLT versus 49.1±31.2 in dual LLT; P=0.970) and triglyceride levels (14.9±36.9 in triple LLT versus 16.8±36.0 in dual LLT;) P=0.718), without differences in adverse events.

三联与双联降脂治疗在降低非高密度脂蛋白胆固醇水平（三联降脂治疗组为49.0±25.4，双联降脂治疗组为49.1±31.2；P=0.970）和甘油三酯水平（三联降脂治疗组为14.9±36.9，双联降脂治疗组为16.8±36.0；P=0.718）方面显示出相似的结果，且不良事件无差异。

Conclusions

Both dual and triple LLT after ACS allow for high rates (>50%) of adequate LDL-C control (<55 mg/dL) at 8 weeks.

无论是双联还是三联降脂治疗，在急性冠脉综合征（ACS）后8周，均能实现高比例（>50%）的适宜低密度脂蛋白胆固醇（LDL-C）控制（<55 mg/dL）。

Adding bempedoic acid to statin-ezetimibe therapy in the setting of ACS is safe but failed to improve the percentage of patients achieving the LDL-C goal (<55 mg/dL) at 8 weeks.

在急性冠脉综合征背景下，将贝美多酸添加到他汀-依折麦布治疗中是安全的，但在8周时未能提高达到LDL-C目标（<55 mg/dL）的患者比例。

Larger, randomized studies are needed to confirm our findings.

需要更大规模的随机研究来确认我们的发现。

registration

URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2021-006550-31.

网址: https://www.clinicaltrialsregister.eu; 唯一标识符: 2021-006550-31.