Background: 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. Methods: 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 2×2 factorial design to unfractionated heparin or enoxaparin. Results: 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. Conclusions: 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.
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