Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism.

However, uncertainty remains about the difference in bleeding risk between the two medications.

然而，关于这两种药物出血风险差异的不确定性仍然存在。

Methods

In an international trial with a prospective, randomized, open-label, blinded end-point design, we assigned, in a 1:1 ratio, eligible patients with acute symptomatic pulmonary embolism or proximal deep-vein thrombosis to receive apixaban or rivaroxaban for 3 months.

在一项国际试验中，我们采用前瞻性、随机、开放标签、盲终点设计，按1:1的比例，将符合条件的急性症状性肺栓塞或近端深静脉血栓形成患者分配接受阿哌沙班或利伐沙班治疗3个月。

Apixaban was given at a dose of 10 mg twice daily for 7 days followed by 5 mg twice daily, and rivaroxaban was given at a dose of 15 mg twice daily for 21 days followed by 20 mg daily.

阿哌沙班的剂量为每日两次，前7天为10毫克，之后为每日两次5毫克；利伐沙班的剂量为每日两次，前21天为15毫克，之后为每日20毫克。

The primary outcome was clinically relevant bleeding, a composite of major bleeding or clinically relevant nonmajor bleeding, as defined according to the International Society on Thrombosis and Haemostasis, during the 3-month trial period.

主要结果是临床相关出血，这是在3个月试验期间根据国际血栓与止血学会定义的主要出血或临床相关非主要出血的复合指标。

Secondary outcomes included death from any cause.

次要结果包括任何原因导致的死亡。

Results

A total of 2760 patients underwent randomization: 1370 to the apixaban group and 1390 to the rivaroxaban group.

共有2760名患者进行了随机分组：1370名患者分入阿哌沙班组，1390名患者分入利伐沙班组。

A primary-outcome event occurred in 44 of 1345 patients (3.3%) in the apixaban group and 96 of 1355 patients (7.1%) in the rivaroxaban group (relative risk, 0.46; 95% confidence interval[CI], 0.33 to 0.65; P<0.001).

在阿哌沙班组的1345名患者中，有44名（3.3%）发生了主要结果事件，在利伐沙班组的1355名患者中，有96名（7.1%）发生了主要结果事件（相对风险，0.46；95%置信区间[CI]，0.33至0.65；P<0.001）。

Death from any cause occurred in 1 patient (0.1%) in the apixaban group and in 4 patients (0.3%) in the rivaroxaban group (relative risk, 0.25; 95% CI, 0.03 to 2.26).

在阿哌沙班组中，有1名患者（0.1%）因任何原因死亡，在利伐沙班组中，有4名患者（0.3%）因任何原因死亡（相对风险为0.25；95%置信区间为0.03至2.26）。

Serious adverse events unrelated to bleeding or venous thrombosis occurred in 36 patients (2.7%) in the apixaban group and in 30 patients (2.2%) in the rivaroxaban group.

与出血或静脉血栓无关的严重不良事件发生在阿哌沙班组的36名患者（2.7%）和利伐沙班组的30名患者（2.2%）中。

Conclusions

Among patients with acute venous thromboembolism, the risk of clinically relevant bleeding was significantly lower with apixaban than with rivaroxaban during the 3-month treatment period.

在急性静脉血栓栓塞患者中，与利伐沙班相比，阿哌沙班在3个月治疗期间的临床相关出血风险显著降低。

(Funded by the Canadian Institutes of Health Research and others; COBRRA ClinicalTrials.gov number, NCT03266783.).

(由加拿大卫生研究院等资助；COBRRA临床试验注册号，NCT03266783。)