Rajagopal Vivek, Lincoff A Michael, Cohen David J, Gurm Hitinder S, Hu Tingfei, Desmet Walter J, Kleiman Neal S, Bittl John A, Feit Frederick, Topol Eric J
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
Am Heart J. 2006 Jul;152(1):149-54. doi: 10.1016/j.ahj.2005.09.007.
The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GPIIb/IIIa) inhibition is not inferior to heparin plus GPIIb/IIIa inhibition in patients undergoing percutaneous coronary intervention. The extent to which this applies to patients with acute coronary syndromes (ACS) is unclear. Therefore, we sought to determine if bivalirudin has similar efficacy in ACS patients as compared with "stable" patients in the REPLACE-2 trial.
We analyzed the outcomes of ACS patients compared with stable patients and the outcomes of ACS patients according to whether or not they had received bivalirudin, including the economic costs. The trial enrolled 1351 ACS patients (myocardial infarction within 7 days or unstable angina within 48 hours, but not on ongoing GPIIb/IIIa or heparin therapy) and 4554 stable patients.
Patients with ACS had a similar rate of death or myocardial infarction at 30 days compared to stable patients (7.2% vs 6.7%, P = .51) and death at 1 year (1.6% vs 2.2%, P = .169), but a higher rate of urgent coronary artery bypass graft at 30 days (1.0% vs 0.3%, P = .002). Patients with ACS treated with bivalirudin had a similar rate of 30-day death, myocardial infarction, or urgent revascularization compared with ACS patients treated with heparin and GPIIb/IIIa inhibitors (8.7% vs 8.0%, P = .616) and death at 1 year (1.5% vs 1.8%, P = .701), but a higher rate of revascularization at 6 months (12% vs 8.4%, P = .04). Patients with ACS treated with bivalirudin had less major bleeding than ACS patients treated with heparin and GPIIb/IIIa inhibitors, although this was not statistically significant (2.7% vs 4.5%, P = .07). Mean 30-day costs for patients with ACS were dollar 12415 for those treated with bivalirudin and dollar 12806 for those treated with heparin plus GPIIb/IIIa inhibitors (P = .022).
Bivalirudin with provisional GPIIb/IIIa inhibitor use in low-risk ACS patients (not receiving preprocedural GPIIb/IIIa blockade) appears to provide similar protection against death and myocardial infarction as the combination of heparin and GPIIb/IIIa inhibitors, although we observed a higher rate of revascularization at 6 months.
REPLACE-2试验表明，在接受经皮冠状动脉介入治疗的患者中，使用比伐卢定临时抑制糖蛋白IIb/IIIa（GPIIb/IIIa）并不逊于肝素加GPIIb/IIIa抑制。这一结论在急性冠状动脉综合征（ACS）患者中的适用程度尚不清楚。因此，我们试图确定在REPLACE-2试验中，与“稳定”患者相比，比伐卢定在ACS患者中是否具有相似的疗效。
我们分析了ACS患者与稳定患者的结局，以及ACS患者根据是否接受比伐卢定治疗的结局，包括经济成本。该试验纳入了1351例ACS患者（7天内发生心肌梗死或48小时内发生不稳定型心绞痛，但未接受正在进行的GPIIb/IIIa或肝素治疗）和4554例稳定患者。
与稳定患者相比，ACS患者30天时的死亡或心肌梗死发生率相似（7.2%对6.7%，P = 0.51），1年时的死亡率相似（1.6%对2.2%，P = 0.169），但30天时紧急冠状动脉搭桥术的发生率更高（1.0%对0.3%，P = 0.002）。与接受肝素和GPIIb/IIIa抑制剂治疗的ACS患者相比，接受比伐卢定治疗的ACS患者30天时死亡、心肌梗死或紧急血运重建的发生率相似（8.7%对8.0%，P = 0.616），1年时的死亡率相似（1.5%对1.8%，P = 0.701），但6个月时血运重建的发生率更高（12%对8.4%，P = 0.04）。与接受肝素和GPIIb/IIIa抑制剂治疗的ACS患者相比，接受比伐卢定治疗的ACS患者严重出血较少，尽管这在统计学上无显著差异（2.7%对4.5%，P = 0.07）。ACS患者中，接受比伐卢定治疗的患者30天平均费用为12415美元，接受肝素加GPIIb/IIIa抑制剂治疗的患者为12806美元（P = 0.022）。
在低风险ACS患者（未接受术前GPIIb/IIIa阻断）中使用比伐卢定临时抑制GPIIb/IIIa，似乎与肝素和GPIIb/IIIa抑制剂联合使用一样，能为预防死亡和心肌梗死提供相似的保护，尽管我们观察到6个月时血运重建的发生率较高。
