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 AMERICAN HEART JOURNAL Adgey, J., Ardissino, D., ARMSTRONG, P., Berger, P., Betriu, A., Beyar, R., Bode, C., Braunwald, E., Brindis, R., Brogan, G., Buller, C., Califf, R., CASTERELLA, P., Gibler, W. B., Giugliano, R., Goldstein, P., Granger, C., Guetta, V., Harrington, R., Herrmann, H., Hochman, J., Hoekstra, J., Kleiman, N., Labinaz, M., Langer, A., Montalescot, G., Ohman, E. M., O'Neill, W., Pollack, C., Roe, M., Satler, L., Schweiger, M., Simoons, M., Steg, G., Tanguay, J. F., Van de Werf, F., Wallentin, L., Zeymer, U. 2005; 150 (1): 116-122


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.

View details for DOI 10.1016/j.ahj.2005.04.005

View details for Web of Science ID 000232219900018

View details for PubMedID 16084157