A Randomized Two-by-Two Comparison of High-Dose Bolus Tirofiban versus Abciximab and Unfractionated Heparin Versus Bivalirudin During Percutaneous Coronary Revascularization and Stent Placement: The Tirofiban Evaluation of Novel Dosing versus Abciximab with Clopidogrel and Inhibition of Thrombin (TENACITY) Study Trial
A Randomized Two-by-Two Comparison of High-Dose Bolus Tirofiban versus Abciximab and Unfractionated Heparin Versus Bivalirudin During Percutaneous Coronary Revascularization and Stent Placement: The Tirofiban Evaluation of Novel Dosing versus Abciximab with Clopidogrel and Inhibition of Thrombin (TENACITY) Study Trial
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DOI：
10.1002/ccd.22876
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发表时间：
2011-06-01
影响因子：
2.3
通讯作者：
Moliterno, David J.
中科院分区：
文献类型：
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作者：
Moliterno, David J.
背景资料：在不使用高剂量噻吩并吡啶类药物的情况下，安慰剂对照试验已证明经皮冠状动脉介入治疗（PCI）期间静脉注射糖蛋白IIb/IIIa拮抗剂可减少缺血事件。一项在PCI患者中比较阿昔单抗和替罗非班的头对头试验发现替罗非班较差，实验室证据证实，在该试验中测试的替罗非班的推注剂量不如阿昔单抗有效。在PCI期间，更高剂量的替罗非班是否与阿昔单抗一样有效尚不确定。方法和结果：接受PCI的患者随机分为阿昔单抗组和替罗非班组，两组均以高剂量推注（25 μ g/kg）加12小时输注（0.15 μ g/kg/min）的方式给药。所有患者均接受阿司匹林和氯吡格雷治疗，并随机接受普通肝素或比伐卢定治疗。大约有8,000名患者接受了研究，但在383名患者入组后，研究申办者因经济原因停止了试验。主要终点为30天死亡、心肌梗死或紧急靶血管血运重建，随机分配至阿昔单抗组的患者中有8.8%，随机分配至替罗非班组的患者中有6.9%。大出血的发生率分别为1.5%和1.6%。此外，8.1%的随机分配至普通肝素组的患者和7.6%的随机分配至比伐卢定组的患者发生了主要终点。大出血率分别为2.5%和0.5%。结论：在有限的评估下，这种高剂量推注替罗非班与阿昔单抗的直接比较产生了令人鼓舞的结果，并表明有必要对这种替罗非班剂量方案进行进一步研究。比较肝素和比伐卢定的有限评估与既往观察结果一致。(C)2011 Wiley-Liss，Inc.
Background: In the absence of high-dose thienopyridines, placebo-controlled trials have demonstrated a reduction in ischemic events with intravenous glycoprotein IIb/IIIa antagonists during percutaneous coronary intervention (PCI). One head-to-head trial comparing abciximab and tirofiban among PCI patients found tirofiban to be inferior, and laboratory evidence confirmed that the bolus dose of tirofiban tested in that trial to be less effective than abciximab. Whether a higher bolus dose of tirofiban would be as efficacious as abciximab during PCI is uncertain. Methods and Results: Patients undergoing PCI were randomized equally to abciximab or to tirofiban, given as high-dose bolus (25 mu g/kg) plus 12-hr infusion (0.15 mu g/kg/min). All patients received aspirin and clopidogrel and were additionally randomized to unfractionated heparin or bivalirudin. Approximately 8,000 patients were to be studied, but after 383 were enrolled, the study sponsor discontinued the trial for financial reasons. The primary endpoint of 30-day death, myocardial infarction, or urgent target vessel revascularization occurred in 8.8% of patients randomized to abciximab and 6.9% of those randomized to tirofiban. The respective rates of major bleeding were 1.5 and 1.6%. Additionally, the primary endpoint occurred in 8.1% of patients randomized to unfractionated heparin and 7.6% of those randomized to bivalirudin. The respective rates of major bleeding were 2.5% and 0.5%. Conclusion: With limited assessment, this direct comparison of high-dose bolus tirofiban versus abciximab produced encouraging results and suggests that further study of this tirofiban dose regimen is warranted. The limited assessments comparing heparin and bivalirudin are consistent with prior observations. (C) 2011 Wiley-Liss, Inc.