Am Heart J. 2005 Jul;150(1):116-22. doi: 10.1016/j.ahj.2005.04.005.
Facilitated percutaneous coronary intervention (PCI)--simultaneous administration of glycoprotein IIb/IIIa inhibitors and reduced-dose fibrinolytics before primary PCI for ST-segment elevation myocardial infarction (STEMI)--may be a promising reperfusion strategy.
The ADVANCE MI trial was intended to evaluate facilitated PCI in 5640 STEMI patients but was prematurely terminated as a result of slow recruitment over 12 months at 30 centers in the United States. Patients with STEMI with planned primary PCI were randomly assigned to receive eptifibatide + 50% of standard-dose tenecteplase (which equated to 0.25 mg/kg intravenous bolus) or eptifibatide + placebo before PCI and randomized in a 2 x 2 factorial design to unfractionated heparin or enoxaparin.
A total of 148 patients were randomized (74 patients in each treatment arm) and formed the "as-randomized" intention-to-treat population. However, only 69 patients actually received eptifibatide + tenecteplase, and 77 actually received eptifibatide + placebo (2 patients did not receive eptifibatide and 4 patients randomized to tenecteplase did not receive this therapy)--these 146 patients formed the "as-treated" population. Among both populations, epicardial infarct artery patency and myocardial tissue perfusion on pre-PCI angiography were improved in the tenecteplase group, but ST-segment resolution at 60 minutes was similar. The frequency of the primary end point of death or new/worsening severe heart failure at 30 days was higher among patients treated with eptifibatide + tenecteplase in the "as-treated" (10% vs 3%, P = .09) and the "as-randomized" (11% vs 1%, P = .02) populations. Bleeding complications were 2-fold higher with eptifibatide + tenecteplase. Analysis of the results by treatment with unfractionated heparin versus enoxaparin demonstrated similar findings.
Although definitive conclusions cannot be made as a result of the small sample size and premature study termination, facilitated PCI with eptifibatide + reduced-dose tenecteplase was associated with improved angiographic flow patterns, increases in adverse clinical outcomes, and higher bleeding rates compared with eptifibatide + placebo administered before primary PCI for STEMI.
易化经皮冠状动脉介入治疗（PCI）——在ST段抬高型心肌梗死（STEMI）患者直接PCI前同时给予糖蛋白IIb/IIIa抑制剂和小剂量纤溶药物——可能是一种有前景的再灌注策略。
ADVANCE MI试验旨在评估5640例STEMI患者的易化PCI，但由于美国30个中心在12个月内入组缓慢而提前终止。计划直接PCI的STEMI患者被随机分配在PCI前接受依替巴肽+50%标准剂量的替奈普酶（相当于0.25mg/kg静脉推注）或依替巴肽+安慰剂，并采用2×2析因设计随机接受普通肝素或依诺肝素治疗。
共148例患者被随机分组（每个治疗组74例），形成“随机化”意向性治疗人群。然而，只有69例患者实际接受了依替巴肽+替奈普酶治疗，77例实际接受了依替巴肽+安慰剂治疗（2例未接受依替巴肽，4例随机接受替奈普酶治疗的患者未接受该治疗）——这146例患者形成“实际治疗”人群。在这两个人群中，替奈普酶组PCI前血管造影显示的心外膜梗死动脉通畅情况和心肌组织灌注均有改善，但60分钟时ST段回落情况相似。在“实际治疗”人群（10%对3%，P=0.09）和“随机化”人群（11%对1%，P=0.02）中，接受依替巴肽+替奈普酶治疗的患者30天时死亡或新发/加重严重心力衰竭的主要终点发生率更高。依替巴肽+替奈普酶治疗的出血并发症发生率高出2倍。对普通肝素与依诺肝素治疗结果的分析显示了相似的结果。
尽管由于样本量小和研究提前终止无法得出明确结论，但与STEMI直接PCI前给予依替巴肽+安慰剂相比，依替巴肽+小剂量替奈普酶的易化PCI与血管造影血流模式改善、不良临床结局增加和出血率升高相关。
