Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial.

AIMS To test the equivalence of high-dose bolus (HDB) tirofiban vs. abciximab during primary percutaneous coronary intervention (PPCI) in terms of ST-segment resolution (STR). METHODS AND RESULTS The FATA trial (Facilitated Angioplasty with Tirofiban or Abciximab) was a prospective, multicentre, open-label trial that enrolled 692 patients with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were randomized 1:1 to receive abciximab (n = 341) or HDB tirofiban (n = 351). Primary endpoint was the rate of complete (> or =70%) STR 90 min after first balloon inflation. Thirty-day incidence of major bleedings, death, re-infarction and new revascularizations was also evaluated. Baseline characteristics of the two groups were well-balanced, with the exception of previous MI rates (tirofiban 6% vs. abciximab 2.6%, P = 0.03). The procedure was successful in 96.7% of the abciximab and in 96.6% of the tirofiban cohort (P = 0.94). Complete STR was obtained in 67.05% of the tirofiban and 70.45% of the abciximab group (Delta -3.4%, 95% confidence interval -10.35 to +3.56), which falls beyond the predefined Delta +/- 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups. CONCLUSION This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.