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European Heart Journal Advance Access originally published online on October 21, 2008
European Heart Journal 2008 29(24):2972-2980; doi:10.1093/eurheartj/ehn467
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org

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

Antonio Marzocchi1, Antonio Manari2, Giancarlo Piovaccari3, Cinzia Marrozzini1, Sebastiano Marra4, Paolo Magnavacchi5, Pietro Sangiorgio6, Lucia Marinucci7, Nevio Taglieri1, Giovanni Gordini8, Nicola Binetti9, Vincenzo Guiducci2, Nicoletta Franco3, Maria Letizia-Bacchi Reggiani1, Francesco Saia1,* on behalf of the FATA Investigators

1 Istituto di Cardiologia, Università di Bologna, Policlinico S Orsola-Malpighi (Pad 21), Via Massarenti, 9, Bologna 40138, Italy
2 Unità Operativa di Cardiologia Interventistica, Ospedale S Maria Nuova, Reggio Emilia, Italy
3 Unità Operativa di Cardiologia, Ospedale degli Infermi, Rimini, Italy
4 Unità Operativa di Cardiologia, Azienda Ospedaliera S, Giovanni Battista, Torino, Italy
5 Unità Operativa di Cardiologia, Ospedale di Baggiovara, Modena, Italy
6 Unità Operativa di Cardiologia, Ospedale Maggiore, Bologna, Italy
7 Servizio di Cardiologia Invasiva, Ospedale di Pesaro, Italy
8 Servizio Emergenza territoriale 118 di Bologna, Ospedale Maggiore, Bologna, Italy
9 U.O. di Pronto Soccorso ed Emergenza Territoriale, Azienda USL Bologna ‘Area Nord’, Bologna, Italy

Received 9 June 2008; revised 4 September 2008; accepted 29 September 2008; online publish-ahead-of-print 21 October 2008.

* Corresponding author. Tel: +39 (0) 51 6364477, Fax: +39 (0) 51 344859, Email: francescosaia{at}hotmail.com

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 (≥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.

Key Words: Angioplasty • Acute myocardial infarction • Reperfusion • Glycoprotein IIb/IIIa inhibitors • ST-resolution

ClinicalTrials.gov Identifier: NCT00383136 [ClinicalTrials.gov]


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