Bivalirudin Versus Heparin in Low and Non-Low Bleeding Risk Patients Undergoing Primary PCI for STEMI: The BRIGHT-4 Trial.

We sought to determine whether the benefits of bivalirudin apply principally to patients who are at low bleeding risk (LBR) as well as non-LBR.

我们试图确定比伐芦定的益处是否主要适用于低出血风险（LBR）患者以及非LBR患者。

Methods

In a prespecified analysis from BRIGHT-4, outcomes were examined by baseline bleeding risk, with LBR defined as a CRUSADE score <30.

在BRIGHT-4的预先指定分析中，通过基线出血风险来检查结果，将LBR定义为CRUSADE评分<30。

Results

At baseline, 4,581 patients (76.1%) were categorized as LBR.

在基线时，4581名患者（76.1%）被归类为LBR。

Non-LBR patients had higher rates of the 30-day primary endpoint (8.6% vs 2.2%; HR: 4.08 [95% CI: 3.14-5.31]; P < 0.0001), driven by both greater mortality and BARC types 3 to 5 bleeding.

非LBR患者的30天主要终点发生率更高（8.6% vs 2.2%；HR：4.08 [95% CI：3.14-5.31]；P < 0.0001），这是由于更高的死亡率和BARC 3至5级出血。

In non-LBR patients, the primary outcome occurred in 8.1% of patients randomized to bivalirudin vs 9.2% of those randomized to heparin (difference: -1.1% [95% CI: -4.0% to 1.8%]; HR: 0.88 [95% CI: 0.62-1.26]).

在非LBR患者中，随机分配到比伐芦定的患者有8.1%发生主要终点事件，而随机分配到肝素的患者为9.2%（差异：-1.1% [95% CI：-4.0%至1.8%]；HR：0.88 [95% CI：0.62-1.26]）。

In LBR patients, the primary outcome occurred in 1.4% of patients randomized to bivalirudin vs 2.9% of those randomized to heparin (difference: -1.5% [95% CI: -2.3% to -0.6%]; HR: 0.49 [95% CI: 0.32-0.75]) (Pabsolute interaction = 0.81; Prelative interaction = 0.04).

在LBR患者中，随机分配到比伐芦定的患者有1.4%发生主要终点事件，而随机分配到肝素的患者为2.9%（差异：-1.5% [95% CI：-2.3%至-0.6%]；HR：0.49 [95% CI：0.32-0.75]）（P绝对交互作用=0.81；P相对交互作用=0.04）。

The effects of bivalirudin compared with heparin in reducing all-cause death were as robust in LBR patients compared with non-LBR patients (Pabsolute interaction = 0.67; Prelative interaction = 0.06).

与非LBR患者相比，比伐芦定与肝素相比，在降低全因死亡方面的作用在LBR患者中同样稳健（P绝对交互作用=0.67；P相对交互作用=0.06）。

Conclusions

Among patients with STEMI undergoing primary PCI with radial artery access, procedural anticoagulation with bivalirudin plus a high-dose post-PCI infusion for 2 to 4 hours reduced the 30-day risk of all-cause death and major bleeding in patients at low bleeding risk as well as in patients at higher-risk of bleeding.

在接受首次经皮冠状动脉介入治疗（PCI）并采用桡动脉途径的ST段抬高型心肌梗死（STEMI）患者中，使用比伐芦定加高剂量PCI后输注2至4小时的程序性抗凝治疗，降低了低出血风险患者以及高出血风险患者30天内全因死亡和主要出血事件的风险。

(Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI [BRIGHT-4; NCT03822975]).

[比伐芦定与紧急PCI期间仅使用肝素的延长全剂量输注（BRIGHT-4; NCT03822975）]