Department of Cardiology, Lund University, Sweden.
Department of Cardiology, Sahlgrenska University Hospital, Sweden.
Eur Heart J Acute Cardiovasc Care. 2019 Sep;8(6):492-501. doi: 10.1177/2048872618805663. Epub 2018 Oct 3.
The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.
In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.
A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78-1.18, =0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68-1.94, =0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58-1.45, =0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77-1.24, =0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30-5.93, =0.82).
Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.
在当代经桡动脉入路和强效 P2Y12 抑制剂治疗非 ST 段抬高型心肌梗死（NSTE-ACS）的临床实践中，对于接受经皮冠状动脉介入治疗（PCI）的 NSTE-ACS 患者，最佳抗凝策略仍不明确。本研究旨在探讨对于未常规使用糖蛋白 IIb/IIIa 抑制剂的 NSTE-ACS 患者，比伐卢定是否优于肝素单药治疗。
在多中心、前瞻性、随机、基于注册的开放性 VALIDATE-SWEDEHEART 试验的一个大型预先指定亚组中，我们将接受替格瑞洛或普拉格雷治疗的 NSTE-ACS 患者随机分为比伐卢定或肝素单药组，且 PCI 期间未计划使用糖蛋白 IIb/IIIa 抑制剂。主要终点为 180 天内全因死亡、心肌梗死或大出血的复合发生率。
共纳入 3001 例 NSTE-ACS 患者。比伐卢定组和肝素组分别有 12.1%（182/1503）和 12.5%（187/1498）的患者发生主要终点事件（比伐卢定组与肝素组相比，风险比为 0.96，95%置信区间为 0.78-1.18，=0.69）。所有主要亚组的结果均一致。全因死亡发生率分别为 2.0%和 1.7%（风险比 1.15，0.68-1.94，=0.61），心肌梗死发生率分别为 2.3%和 2.5%（风险比 0.91，0.58-1.45，=0.70），大出血发生率分别为 8.9%和 9.1%（风险比 0.97，0.77-1.24，=0.82），明确的支架血栓形成发生率分别为 0.3%和 0.2%（风险比 1.33，0.30-5.93，=0.82）。
在接受当前推荐的使用新型 P2Y12 抑制剂和经桡动脉入路为主的治疗方案的 NSTE-ACS 患者中，与肝素相比，PCI 期间使用比伐卢定并未降低全因死亡、心肌梗死或大出血的复合发生率。
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