Department of Cardiology, Bern University Hospital, Bern, Switzerland; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
Advice Pharma Group S.r.l., Milan, Italy.
J Am Coll Cardiol. 2018 Mar 20;71(11):1231-1242. doi: 10.1016/j.jacc.2018.01.033.
Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs).
This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management.
In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding).
Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site.
In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).
关于计划使用糖蛋白 IIb/IIIa 抑制剂（GPI）时比伐卢定和普通肝素（UFH）的相对疗效和安全性，存在相互矛盾的证据。
本研究评估了比伐卢定与 UFH 加或不加 GPI 用于接受有创治疗的急性冠状动脉综合征（ACS）患者的疗效和安全性。
在 MATRIX（通过桡动脉入路和系统实施 AngioX 减少出血不良事件）研究中，7213 例患者被随机分配接受比伐卢定或 UFH 加或不加 GPI，具体用药由术者决定。30 天的主要复合终点为主要不良心血管事件（MACEs）（死亡、心肌梗死或卒中的复合终点）和净不良临床事件（NACEs）（MACEs 或主要出血的复合终点）。
在接受 UFH 的 3603 例患者中，781 例（21.7%）在冠状动脉介入治疗前接受了计划的 GPI 治疗。比伐卢定组和 UFH 组的 GPI 挽救性使用率相似（4.5%和 5.4%）（p=0.11）。在 30 天时，在调整后，3 组之间 2 个主要复合终点 MACEs 和 NACEs 以及死亡率、心肌梗死、支架血栓形成或卒中的各个终点均无差异。与 UFH 和 UFH+GPI 组相比，比伐卢定减少了出血，主要是最严重的出血，包括致死性和非入路部位相关事件，以及输血率和需要手术入路修复。这些发现不受术中给予的 UFH 剂量的影响，并在包括随机分配的入路部位的多次敏感性分析中得到证实。
在 ACS 患者中，与 UFH 相比，比伐卢定并未显著降低 MACEs 和 NACEs 的发生率，无论是否计划使用 GPI。然而，比伐卢定显著减少了出血并发症，主要是与入路无关的出血并发症，无论是否计划使用 GPI。（通过桡动脉入路和系统实施 AngioX 减少出血不良事件[MATRIX]；NCT01433627）。
