Low-dose aspirin versus placebo in postpartum venous thromboembolism: a multi-national, pilot, randomised, placebo-controlled trial.

We aimed to assess the feasibility of conducting a double-blind, randomised trial of aspirin versus placebo in postpartum individuals with two or more venous thromboembolism risk factors, mild-to-moderate thrombophilia, or both.

我们旨在评估在有两项或两项以上静脉血栓栓塞症风险因素、轻度至中度血栓倾向或两者兼有的产后个体中，进行阿司匹林与安慰剂双盲随机试验的可行性。

Methods

The pilot PARTUM trial, a multi-national, randomised, double-blind, placebo-controlledtrial, was conducted in seven centres across Canada, France, Ireland, and the Netherlands.

试点 PARTUM 试验是一项跨国的、随机的、双盲的、安慰剂对照试验，在加拿大、法国、爱尔兰和荷兰的七个中心进行。

Postpartum individuals aged 18 years or older with venous thromboembolism risk factors, including mild-moderate inherited thrombophilia, antepartum immobilisation, pre-pregnancy BMI of 30 kg/m2 or higher, pre-pregnancy smoking, previous superficial vein thrombosis, and other pregnancy-related conditions, were eligible.

年龄在18岁或以上的产后个体，具有静脉血栓栓塞风险因素，包括轻度至中度的遗传性血栓倾向、产前固定、孕前BMI为30 kg/m2或更高、孕前吸烟、既往浅表静脉血栓形成以及其他与妊娠相关的状况，均符合入选条件。

Participants were randomly assigned (1:1) within 48 h of delivery to aspirin 81 mg (80 mg in Europe) orally daily (low-dose aspirin group) or placebo orally once daily (placebo group) for 42 days.

参与者在分娩后48小时内按1:1的比例随机分配，接受每日口服81毫克阿司匹林（欧洲为80毫克）（低剂量阿司匹林组）或每日口服安慰剂一次（安慰剂组），持续42天。

Follow-up visits occurred at 6 weeks and 90 days postpartum.

产后随访访问分别在6周和90天进行。

The primary outcome was the mean recruitment rate (participants per site per month).

主要结果是平均招募率（每站点每月参与者数）。

Additional feasibility metrics were reported, and clinical outcomes were analysed by intention to treat.

还报告了其他可行性指标，并按治疗意向分析了临床结果。

This study is registered with ClinicalTrials.gov, NCT04153760, and EudraCT, 2020-000619-58, and is completed.

该研究已在ClinicalTrials.gov注册，编号为NCT04153760，在EudraCT注册，编号为2020-000619-58，并已完成。

Results

Between Nov 2, 2020, and June 19, 2023, 10 040 patients were assessed for eligibility and 808 met all eligibility criteria, of whom 257 (32%) provided consent and were enrolled. 127 were randomly assigned to the low-dose aspirin group and 130 to the placebo group.

在2020年11月2日至2023年6月19日期间，共有10,040名患者接受了资格评估，其中808名符合所有资格标准，有257名（占32%）同意并被纳入研究。其中127名被随机分配到低剂量阿司匹林组，130名被分配到安慰剂组。

The median follow-up was 91 days (IQR 89-96).

中位随访时间为91天（四分位数间距89-96天）。

The median age was 34·0 years (IQR 30·0-37·0), and 161 (63%) of participants were White.

中位年龄为34.0岁（四分位数间距30.0-37.0岁），且161名（63%）参与者为白人。

The mean recruitment rate was 6·3 (95% CI 5·5 to 7·2) patients per site per month.

平均每个站点每月的招募率为6.3（95% CI 5.5至7.2）名患者。

No venous thromboembolism events occurred in the low-dose aspirin group, and one participant had distal deep vein thrombosis in the placebo group (-0·82 [95% CI -2·42 to 0·78]).

低剂量阿司匹林组未发生任何静脉血栓栓塞事件，而在安慰剂组中，有一名参与者发生了远端深静脉血栓（-0.82 [95% CI -2.42至0.78]）。

No major bleeds occurred.

未发生主要出血事件。

Three (2%) participants in the low-dose aspirin group versus one (1%) in the placebo group had clinically relevant non-major bleeds (absolute risk difference 1·66 [95% CI -1·54 to 4·86]).

低剂量阿司匹林组有三名（2%）参与者与安慰剂组的一名（1%）参与者出现了临床上相关的非主要出血事件（绝对风险差异1·66 [95% 置信区间 -1·54 至 4·86]）。

Ten serious adverse events occurred in nine (4%) of 257 participants, and 11 serious adverse events occurred in ten (4%) of 271 infants of participants.

在257名参与者中，有9人（占4%）发生了10起严重不良事件；在271名参与者的婴儿中，有10人（占4%）发生了11起严重不良事件。

No treatment-related death occurred.

未发生与治疗相关的死亡事件。

interpretation

A global postpartum thromboprophylaxis trial evaluating low-dose aspirin is possible and needed to provide high-quality data.

开展一项评估低剂量阿司匹林的全球产后血栓预防试验是可能的，也是必要的，以提供高质量的数据。

funding

Canadian Institutes of Health Research and the INVENT-VTE Network.

加拿大健康研究院和INVENT-VTE网络。