Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia.

The PREVAPIX-ALL trial was an open-label, randomized, controlled trial assessing the safety and efficacy of apixaban for VTE prevention in pediatric patients with ALL/LL.

PREVAPIX-ALL试验是一项开放标签、随机、对照试验，评估了阿哌沙班预防ALL/LL儿童患者VTE的安全性和有效性。

An a priori subgroup analysis of patients with obesity in the PREVAPIX-ALL trial was planned because of increased VTE risk in this group.

在PREVAPIX-ALL试验中，由于肥胖患者群体中静脉血栓栓塞（VTE）风险增加，因此计划进行了预先设定的肥胖患者亚组分析。

Patients with obesity, aged ≥2 to <18 years, central venous catheter, and chemotherapy containing asparaginase were randomized to apixaban (prophylactic dose) vs standard of care (SOC; no anticoagulation) during induction chemotherapy.

肥胖患者，年龄≥2岁至<18岁，中心静脉导管，以及含有门冬酰胺酶的化疗患者，在诱导化疗期间被随机分配至阿哌沙班（预防剂量）与标准治疗（SOC；无抗凝治疗）进行比较。

The primary efficacy end point was a composite of nonfatal symptomatic and asymptomatic VTE and VTE-related death.

主要疗效终点是包括非致命性症状性和无症状性静脉血栓栓塞症(VTE)以及与VTE相关的死亡的复合终点。

The primary and secondary safety outcomes were major bleeding and a composite of major and clinically relevant nonmajor (CRNM) bleeding, respectively.

主要和次要安全性结果分别是主要出血和包括主要出血和临床相关的非主要出血(CRNM)的复合终点。

A total of 82 PREVAPIX-ALL participants presented with obesity, of whom 42 were randomized to apixaban.

共有82名PREVAPIX-ALL参与者出现肥胖，其中42人被随机分配到阿哌沙班组。

For the primary efficacy end point, a significant decrease in VTE events was present in the apixaban arm (1/42 [2.4%]) as compared with the SOC arm (10/40 [25%]; relative risk [RR], 0.09; 95% confidence interval[CI], 0.01-0.97; P = .007).

对于主要疗效终点，阿哌沙班组（1/42 [2.4%]）与标准治疗组（10/40 [25%]）相比，VTE事件显著减少（相对风险[RR]，0.09；95%置信区间[CI]，0.01-0.97；P = .007）。

There was a statistically significant treatment obesity interaction, P = .03.

存在统计学上显著的治疗肥胖相互作用，P = .03。

No statistically significant difference was observed for the primary efficacy end point among the nonobese group (RR, 0.85; 95% CI, 0.53-1.37; P = .50).

在非肥胖组中，未观察到主要疗效终点的统计学显著差异（RR, 0.85; 95% 置信区间, 0.53-1.37; P = .50）。

No statistically significant difference in major or CRNM bleeding was observed.

在主要或CRNM出血方面未观察到统计学上的显著差异。

Apixaban prophylaxis in patients with obesity and ALL/LL resulted in a statistically significant VTE risk reduction with no increase bleeding.

在肥胖及ALL/LL患者中，阿哌沙班预防治疗显著降低了VTE风险，且未增加出血事件。

This trial was registered at www.clinicaltrials.gov as #NCT02369653.

该试验已在www.clinicaltrials.gov上注册，注册号为#NCT02369653。