Atorvastatin and Aortic Stiffness During Anthracycline-Based Chemotherapy: A Secondary Analysis of a Randomized Clinical Trial.

There is no evidence-based intervention to prevent anthracycline-associated vascular dysfunction.

目前没有基于证据的干预措施可以预防与蒽环类药物相关的血管功能障碍。

Background

To investigate whether atorvastatin pretreatment is associated with attenuation of the anthracycline-induced increase in aortic stiffness.

研究阿托伐他汀预处理是否与减轻葱环类药物引起的主动脉僵硬度增加有关。

DESIGN, SETTING, AND PARTICIPANTS: This study is a secondary analysis of a double-blind, randomized clinical trial (Statins to Prevent the Cardiotoxicity From Anthracyclines [STOP-CA]).

设计、环境和参与者：本研究是对一项双盲、随机临床试验（他汀类药物预防葱环类药物心脏毒性[STOP-CA]）的次要分析。

Enrollment occurred between January 25, 2017, and September 10, 2021, with the last follow-up on October 10, 2022.

招募工作发生在2017年1月25日至2021年9月10日之间，最后一次随访是在2022年10月10日。

Primary analyses were reported on August 8, 2023.

主要分析结果于2023年8月8日报告。

STOP-CA was a multicenter trial across 9 academic centers in the US and Canada.

STOP-CA 是一项在美国和加拿大的9个学术中心进行的多中心试验。

Participants were patients with newly diagnosed lymphoma scheduled to undergo anthracycline-based chemotherapy with no clinical indication for a statin.

参与者是新诊断为淋巴瘤的患者，计划接受葱环类化疗，且没有使用他汀类药物的临床指征。

intervention

Atorvastatin (40 mg, once daily) or placebo for 12 months.

阿托伐他汀（每日一次40毫克）或安慰剂，持续12个月。

main_outcomes_and_measures

This subanalysis of the STOP-CA trial includes post hoc end points with cardiac magnetic resonance imaging-derived aortic arch pulse wave velocity (PWV) and aortic distensibility (AD).

这是STOP-CA试验的子分析，包括心脏磁共振成像导出的主动脉弓脉搏波速度（PWV）和主动脉顺应性（AD）的回顾性终点。

An intention-to-treatapproach was applied.

采用了意向治疗分析方法。

The proportions of participants with a 1 SD or more increase in PWV and a 1 SD or more decrease in ascending aortic distensibility (AAD) were calculated in each group over 12 months.

在12个月期间，计算了每组中脉搏波传导速度（PWV）增加1个标准差（SD）或以上以及升主动脉顺应性（AAD）减少1个标准差（SD）或以上的参与者比例。

An increase in PWV of 0.15 m per second or more, a previously defined annual rate in individuals of similar age, was also assessed as a secondary end point.

PWV每秒增加0.15米或以上，这是在类似年龄的个体中先前定义的年增长率，也被评估为次要终点。

Results

Of the 300 participants (150 randomized to atorvastatin and 150 randomized to placebo), 152 (mean [SD] age, 51 [17] years; 72 female [47%]; 82 treated with atorvastatin) had paired PWV data, and 168 had paired AD data.

在300名参与者中（150人被随机分配到阿托伐他汀组，150人被随机分配到安慰剂组），有152人（平均年龄[标准差]为51[17]岁；72名女性[47%]；82人接受阿托伐他汀治疗）有配对的PWV数据，168人有配对的AD数据。

The PWV values remained similar in the atorvastatin group (mean [SD], 6.5 [1.9] vs 6.5 [2.0] m per second) but increased in the placebo group (5.7 [1.8] vs 6.8 [2.0] m per second) over 12 months.

在阿托伐他汀组中，PWV值在12个月内保持相似（平均值[标准差]，6.5 [1.9] 对比 6.5 [2.0] 米/秒），但在安慰剂组中有所增加（5.7 [1.8] 对比 6.8 [2.0] 米/秒）。

A 1 SD or more increase (0.8 m per second) in PWV was observed among 4 of 82 patients (5%) with atorvastatin and 35 of 70 patients (50%) with placebo (odds ratio, 0.05; 95% CI, 0.02 to 0.16; P < .001) at 12 months.

在12个月时，观察到82名使用阿托伐他汀的患者中有4名（5%）和70名使用安慰剂的患者中有35名（50%）的PWV值增加了1个标准差或更多（0.8米/秒）（比值比为0.05；95%置信区间为0.02至0.16；P < .001）。

A 1 SD or more decrease (1.8 × 10-3 mm Hg-1) in AAD was observed among 6 of 88 patients (7%) with atorvastatin and in 14 of 80 patients (18%) with placebo.

在88名使用阿托伐他汀的患者中，有6名（7%）观察到主动脉脉搏波传导速度（AAD）下降1个标准差或更多（1.8 × 10^-3 mm Hg^-1），而在80名使用安慰剂的患者中，有14名（18%）观察到这一现象。

A 1 SD or more increase in PWV was associated with a mean left ventricular ejection fraction decline of 2.70% (95% CI, -4.65% to -0.81%; P = .006).

脉搏波传导速度（PWV）增加1个标准差或更多与左心室射血分数平均下降2.70%相关（95% 置信区间，-4.65% 至 -0.81%；P = .006）。

conclusions_and_relevance

Pretreatment with atorvastatin was associated with preservation of vascular function among patients with lymphoma undergoing anthracycline-based chemotherapy.

在使用葱环类药物化疗的淋巴瘤患者中，阿托伐他汀的预处理与血管功能的保护相关。

trial_registration

ClinicalTrials.gov Identifier: NCT02943590.

ClinicalTrials.gov 注册号：NCT02943590。