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Antonio Marzocchi, Antonio Manari, Giancarlo Piovaccari, Cinzia Marrozzini, Sebastiano Marra, Paolo Magnavacchi, Pietro Sangiorgio, Lucia Marinucci, Nevio Taglieri, Giovanni Gordini, Nicola Binetti, Vincenzo Guiducci, Nicoletta Franco, Maria Letizia-Bacchi Reggiani, Francesco Saia, on behalf of the FATA Investigators, 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, European Heart Journal, Volume 29, Issue 24, December 2008, Pages 2972–2980, https://doi.org/10.1093/eurheartj/ehn467
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Abstract
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).
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 (≥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 (Δ −3.4%, 95% confidence interval −10.35 to +3.56), which falls beyond the predefined Δ ± 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups.
This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.