Am Heart J. 2001 Mar;141(3):402-9. doi: 10.1067/mhj.2001.113391.
This study examined the economics, pharmacodynamics, and clinical outcomes among patients randomly assigned to receive either abciximab (ReoPro, Centocor, Inc, Malvern, Pa, and Eli Lilly & Company, Indianapolis, Ind) or eptifibatide (Integrilin, COR Therapeutics, Inc, South San Francisco, Calif, and Key Pharmaceuticals, Inc, Kenilworth, NJ) therapy during elective percutaneous coronary intervention (PCI).
Clinical and safety outcomes after elective PCI with a high-dose eptifibatide treatment strategy have not previously been systematically evaluated. In addition, comparative economic and pharmacodynamic studies of platelet glycoprotein (GP) IIb/IIIa receptor antagonists during PCI are sparse.
This randomized, double-blind study assessed the 30-day economic and clinical outcomes of 320 consecutive patients undergoing elective coronary balloon angioplasty or stent implantation who were randomly assigned to receive adjunct abciximab (n = 163) or eptifibatide (n = 157) therapy. The primary study end point was total in-hospital costs based on an intention-to-treat analysis. A secondary end point included 30-day total hospital costs. A platelet aggregometry substudy was performed on 155 patients (abciximab: n = 74 and eptifibatide: n = 81) with use of the Ultegra Rapid Platelet Function Assay.
Baseline demographic, angiographic, and procedural variables were similar between the two treatment groups. The median and interquartile ranges of total in-hospital costs were $8268 ($6505, $9958) and $7207 ($5659, $9307), respectively, between the abciximab- and eptifibatide-treated patients (P =.009). Median total costs at 30 days were $8336 ($6505, $10,126) and $7207 ($5659, $9431), respectively, between the abciximab- and eptifibatide-treated groups (P =.009). The composite secondary clinical end points (death/nonfatal myocardial infarction/urgent revascularization) occurred in 4.9% versus 5.1% of patients, respectively, by hospital discharge (P =.84) and in 5.6% versus 6.3% of patients, respectively, at 30 days (P =.95) in the abciximab and eptifibatide groups. With the eptifibatide dose used, early and more durable platelet inhibition was achieved compared with abciximab (P <.00001).
In drug dosages and patients similar to those enrolled in the current study, eptifibatide achieved durable platelet inhibition throughout drug infusion and was associated with lower in-hospital and 30-day costs compared with abciximab in patients undergoing elective PCI.
本研究对在择期经皮冠状动脉介入治疗(PCI)期间随机接受阿昔单抗(ReoPro,Centocor公司,宾夕法尼亚州马尔伯勒市,以及礼来公司,印第安纳州印第安纳波利斯市)或依替巴肽(Integrilin,COR Therapeutics公司,加利福尼亚州南旧金山,以及Key Pharmaceuticals公司,新泽西州肯尼沃斯)治疗的患者的经济学、药效学及临床结局进行了研究。
此前尚未对采用高剂量依替巴肽治疗策略进行择期PCI后的临床及安全性结局进行系统评估。此外,关于PCI期间血小板糖蛋白(GP)IIb/IIIa受体拮抗剂的比较经济学及药效学研究较少。
本随机、双盲研究评估了320例连续接受择期冠状动脉球囊血管成形术或支架植入术的患者的30天经济学及临床结局,这些患者被随机分配接受辅助阿昔单抗治疗(n = 163)或依替巴肽治疗(n = 157)。主要研究终点为基于意向性分析的住院总费用。次要终点包括30天的总住院费用。对155例患者(阿昔单抗组:n = 74;依替巴肽组:n = 81)进行了血小板聚集试验亚研究,采用Ultegra快速血小板功能检测法。
两个治疗组之间的基线人口统计学、血管造影及手术变量相似。阿昔单抗治疗组和依替巴肽治疗组患者的住院总费用中位数及四分位数间距分别为8268美元(6505美元,9958美元)和7207美元(5659美元,9307美元)(P = 0.009)。阿昔单抗治疗组和依替巴肽治疗组在30天时的总费用中位数分别为8336美元(6505美元,10126美元)和7207美元(5659美元,9431美元)(P = 0.009)。复合次要临床终点(死亡/非致命性心肌梗死/紧急血运重建)在出院时分别发生于4.9%和5.1%的患者中(P = 0.84),在30天时分别发生于5.6%和6.3%的患者中(P = 0.95),阿昔单抗组和依替巴肽组。与阿昔单抗相比,使用依替巴肽剂量可实现更早且更持久的血小板抑制(P < 0.00001)。
在与本研究纳入的患者相似的药物剂量及患者中,依替巴肽在整个药物输注过程中实现了持久的血小板抑制,并且与接受择期PCI的患者使用阿昔单抗相比,住院及30天费用更低。