Marzocchi Antonio, Manari Antonio, Piovaccari Giancarlo, Marrozzini Cinzia, Marra Sebastiano, Magnavacchi Paolo, Sangiorgio Pietro, Marinucci Lucia, Taglieri Nevio, Gordini Giovanni, Binetti Nicola, Guiducci Vincenzo, Franco Nicoletta, Reggiani Maria Letizia-Bacchi, Saia Francesco
Istituto di Cardiologia, Università di Bologna, Policlinico S Orsola-Malpighi, Via Massarenti, 9, Bologna 40138, Italy.
Eur Heart J. 2008 Dec;29(24):2972-80. doi: 10.1093/eurheartj/ehn467. Epub 2008 Oct 21.
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 (> 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.
This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.
在直接经皮冠状动脉介入治疗（PPCI）期间，就ST段回落（STR）情况测试大剂量推注（HDB）替罗非班与阿昔单抗的等效性。
FATA试验（替罗非班或阿昔单抗辅助血管成形术）是一项前瞻性、多中心、开放标签试验，纳入了692例接受PPCI的ST段抬高型心肌梗死（STEMI）患者。患者按1:1随机分组，分别接受阿昔单抗（n = 341）或HDB替罗非班（n = 351）。主要终点是首次球囊扩张后90分钟时完全（≥70%）STR的发生率。还评估了30天内大出血、死亡、再梗死和新的血管重建的发生率。两组的基线特征均衡良好，但既往心肌梗死发生率除外（替罗非班组为6%，阿昔单抗组为2.6%，P = 0.03）。阿昔单抗组96.7%的患者手术成功，替罗非班组96.6%的患者手术成功（P = 0.94）。替罗非班组67.05%的患者和阿昔单抗组70.45%的患者实现了完全STR（差异为-3.4%，95%置信区间为-10.35至+3.56），超出了预先定义的差异±10%的等效界限。两组的次要终点发生率相似。
本研究未能显示替罗非班的HBD与阿昔单抗作为PPCI辅助治疗的等效性。
