Bempedoic Acid and Venous Thromboembolism Risk Among Statin-Intolerant Patients: A Post Hoc Analysis of the CLEAR Outcomes Randomized Clinical Trial.

The effect of bempedoic acid on VTE risk is unknown.

苯甲酸酸对VTE风险的影响尚不清楚。

Background

To determine whether bempedoic acid is associated with a reduced risk of VTE.

确定贝美多酸是否与降低静脉血栓栓塞（VTE）风险相关。

DESIGN, SETTING, AND PARTICIPANTS: CLEAR Outcomes was a randomized, double-blind, placebo-controlled, cardiovascular outcomes clinical trial. Statin-intolerant individuals at high risk for or with established atherosclerotic cardiovascular disease who were aged 18 to 85 years were enrolled between December 22, 2016, and August 14, 2019, in 1250 centers across 32 countries.

设计、设置和参与者：CLEAR Outcomes是一项随机、双盲、安慰剂对照的心血管结果临床试验。招募了年龄在18至85岁之间，对他汀类药物不耐受且有高风险或已确诊动脉粥样硬化性心血管疾病的个体。这些参与者在2016年12月22日至2019年8月14日期间，在32个国家的1250个中心进行了登记。

The statistical analysis for the present study was conducted between March 10, 2025, and February 19, 2026.

本研究的统计分析是在2025年3月10日至2026年2月19日之间进行的。

Methods

Participants were randomized to oral bempedoic acid, 180 mg, or placebo daily.

参与者被随机分配到每日口服180毫克的贝美多酸或安慰剂。

main_outcomes_and_measures

The main outcome for this analysis was the time to first occurrence of VTE (composite of deep vein thrombosis or pulmonary embolism).

此次分析的主要结果是首次发生静脉血栓栓塞事件（深静脉血栓形成或肺栓塞的复合结果）的时间。

The occurrences of deep vein thrombosis and pulmonary embolism were also assessed.

同时评估了深静脉血栓形成和肺栓塞的发生情况。

Results

A total of 13 970 participants (mean [SD] age, 65.5 [9.0] years; 6740 [48.2%] female) were randomized, 6992 to bempedoic acid and 6978 to placebo.

共有13970名参与者（平均年龄[标准差]为65.5[9.0]岁；6740名[48.2%]为女性）被随机分配，6992人接受苯佩多酸治疗，6978人接受安慰剂。

At the time of randomization, 275 participants (2.0%) had a history of VTE, and 1219 (8.7%) were receiving systemic anticoagulation.

随机分组时，275名参与者（2.0%）有静脉血栓栓塞症（VTE）病史，1219名（8.7%）正在接受全身抗凝治疗。

The participants were followed up for a median (IQR) of 40.6 (37.1-46.2) months.

参与者被随访了中位数（四分位数间距）40.6（37.1-46.2）个月。

A total of 106 VTE events occurred (39 in the bempedoic acid group and 67 in the placebo group; hazard ratio[HR], 0.58; 95% CI, 0.39-0.86; P = .006).

共有106起VTE事件发生（贝美多酸组39起，安慰剂组67起；风险比[HR]，0.58；95%置信区间，0.39-0.86；P = .006）。

Findings were consistent for deep vein thrombosis (HR, 0.56; 95% CI, 0.31-0.996; P = .045) and pulmonary embolism (HR, 0.61; 95% CI, 0.37-0.996; P = .046).

研究结果对于深静脉血栓形成（HR，0.56；95% CI，0.31-0.996；P = .045）和肺栓塞（HR，0.61；95% CI，0.37-0.996；P = .046）是一致的。

conclusions_and_relevance

Treatment with bempedoic acid among participants with statin intolerance at high risk for or with established cardiovascular disease was associated with a reduced risk of VTE.

在对他汀类药物不耐受且有心血管疾病高风险或已确诊的参与者中，使用苯普酸治疗与降低静脉血栓栓塞（VTE）风险相关。

trial_registration

ClinicalTrials.gov Identifier: NCT02993406.

临床试验注册号：NCT02993406。