Facilitated percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: results from the prematurely terminated ADdressing the Value of facilitated ANgioplasty after Combination therapy or Eptifibatide monotherapy in acute Myocardial Infarction (ADVANCE MI) trial.
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 x 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.
ADVANCE MI Investigators,
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