European Heart Journal Advance Access published online on October 21, 2008
European Heart Journal, doi:10.1093/eurheartj/ehn467
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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
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.
* 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 (
–3.4%, 95% confidence interval –10.35 to +3.56), which falls beyond the predefined ± 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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