Department of Cardiology, Bern University Hospital, Bern, Switzerland and Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
EuroIntervention. 2019 Jun 12;15(3):e269-e278. doi: 10.4244/EIJ-D-18-00247.
Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management.
In the MATRIX programme, 7,213 patients were randomised to bivalirudin or UFH. Patients in the bivalirudin group were subsequently randomly assigned to receive or not a post-PCI bivalirudin infusion. The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding. The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target vessel revascularisation (TVR), definite stent thrombosis (ST), or NACE. The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio [RR] 0.90, 95% confidence interval [CI]: 0.75-1.07; p=0.22) and female patients (RR 1.06, 95% CI: 0.80-1.40; p=0.67) without significant interaction (pint=0.31), nor was the rate of NACE (males: RR 0.85, 95% CI: 0.72-1.01; p=0.07; females: RR 0.98, 95% CI: 0.76-1.28; p=0.91; pint=0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: RR 0.84, 95% CI: 0.66-1.07; p=0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; pint=0.28).
In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes. The rate of the composite of urgent TVR, definite ST, or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.
本研究旨在评估在接受介入治疗的急性冠脉综合征（ACS）男性和女性患者中，与普通肝素（UFH）相比，比伐卢定是否具有一致的临床结局。
在 MATRIX 研究中，7213 例患者被随机分至比伐卢定组或 UFH 组。比伐卢定组患者随后被随机分为接受或不接受 PCI 后比伐卢定输注。30 天的主要复合终点事件（MACE）定义为死亡、心肌梗死或卒中，净临床不良事件（NACE）定义为 MACE 或主要出血。PCI 后比伐卢定输注与无 PCI 后比伐卢定输注的主要比较终点为紧急靶血管血运重建（TVR）、明确支架血栓形成（ST）或 NACE 的复合终点。与肝素相比，比伐卢定并未显著降低男性（比值比 [RR] 0.90，95%置信区间 [CI]：0.75-1.07；p=0.22）和女性患者（RR 1.06，95%CI：0.80-1.40；p=0.67）的 MACE 发生率（无显著交互作用，pint=0.31），NACE 发生率也无显著差异（男性：RR 0.85，95%CI：0.72-1.01；p=0.07；女性：RR 0.98，95%CI：0.76-1.28；p=0.91；pint=0.38）。与无输注相比，PCI 后比伐卢定输注并未显著降低紧急 TVR、明确 ST 或 NACE 的发生率（男性：RR 0.84，95%CI：0.66-1.07；p=0.15；女性：RR 1.06，95%CI：0.74-1.53；p=0.74；pint=0.28）。
在 ACS 患者中，比伐卢定在两性中的 MACE 和 NACE 发生率均不比 UFH 低。在两性中，与无 PCI 后比伐卢定输注相比，PCI 后比伐卢定输注并未显著降低紧急 TVR、明确 ST 或 NACE 的复合发生率。
