Deutsches Herzzentrum, Technische Universität, Munich, Germany.
N Engl J Med. 2011 Nov 24;365(21):1980-9. doi: 10.1056/NEJMoa1109596. Epub 2011 Nov 13.
The combination of glycoprotein IIb/IIIa inhibitors and heparin has not been compared with bivalirudin in studies specifically involving patients with non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). We compared the two treatments in this patient population.
Immediately before PCI, we randomly assigned, in a double-blind manner, 1721 patients with acute non-ST-segment elevation myocardial infarction to receive abciximab plus unfractionated heparin (861 patients) or bivalirudin (860 patients). The study tested the hypothesis that abciximab and heparin would be superior to bivalirudin with respect to the primary composite end point of death, large recurrent myocardial infarction, urgent target-vessel revascularization, or major bleeding within 30 days. Secondary end points included the composite of death, any recurrent myocardial infarction, or urgent target-vessel revascularization (efficacy end point) and major bleeding (safety end point) within 30 days.
The primary end point occurred in 10.9% of the patients in the abciximab group (94 patients) and in 11.0% in the bivalirudin group (95 patients) (relative risk with abciximab, 0.99; 95% confidence interval [CI], 0.74 to 1.32; P=0.94). Death, any recurrent myocardial infarction, or urgent target-vessel revascularization occurred in 12.8% of the patients in the abciximab group (110 patients) and in 13.4% in the bivalirudin group (115 patients) (relative risk, 0.96; 95% CI, 0.74 to 1.25; P=0.76). Major bleeding occurred in 4.6% of the patients in the abciximab group (40 patients) as compared with 2.6% in the bivalirudin group (22 patients) (relative risk, 1.84; 95% CI, 1.10 to 3.07; P=0.02).
Abciximab and unfractionated heparin, as compared with bivalirudin, failed to reduce the rate of the primary end point and increased the risk of bleeding among patients with non-ST-segment elevation myocardial infarction who were undergoing PCI. (Funded by Nycomed Pharma and others; ISAR-REACT 4 ClinicalTrials.gov number, NCT00373451.).
在专门涉及接受经皮冠状动脉介入治疗（PCI）的非 ST 段抬高型心肌梗死患者的研究中，尚未比较糖蛋白 IIb/IIIa 抑制剂联合肝素与比伐卢定的疗效。我们在该患者人群中对这两种治疗方法进行了比较。
在 PCI 前，我们采用双盲法将 1721 例急性非 ST 段抬高型心肌梗死患者随机分为两组，分别接受阿昔单抗加普通肝素（861 例）或比伐卢定（860 例）治疗。该研究检验了阿昔单抗加肝素与比伐卢定相比在主要复合终点（30 天内死亡、大的复发性心肌梗死、紧急靶血管血运重建或大出血）方面更优的假设。次要终点包括 30 天内死亡、任何复发性心肌梗死或紧急靶血管血运重建（疗效终点）和大出血（安全性终点）的复合终点。
阿昔单抗组有 10.9%（94 例）的患者发生主要终点事件，比伐卢定组有 11.0%（95 例）（阿昔单抗组的相对风险，0.99；95%置信区间[CI]，0.74 至 1.32；P=0.94）。阿昔单抗组有 12.8%（110 例）的患者发生死亡、任何复发性心肌梗死或紧急靶血管血运重建，比伐卢定组有 13.4%（115 例）（相对风险，0.96；95%CI，0.74 至 1.25；P=0.76）。阿昔单抗组有 4.6%（40 例）的患者发生大出血，比伐卢定组有 2.6%（22 例）（相对风险，1.84；95%CI，1.10 至 3.07；P=0.02）。
与比伐卢定相比，阿昔单抗加普通肝素并未降低非 ST 段抬高型心肌梗死患者 PCI 后的主要终点发生率，反而增加了出血风险。（由 Nycomed Pharma 等资助；ISAR-REACT 4 ClinicalTrials.gov 编号，NCT00373451。）
