FATA研究入选患者680例，年龄相差在18岁或者更多，所有患者均在出现STEMI后6小时内接受直接PCI，患者平均分成两组，其中阿昔单抗组患者首剂是0.25 mg/kg，随后12小时内剂量为0.125 μg/kg/min，替罗非班组首剂是5 μg/kg，随后18小时内剂量为0.15 μg/kg/min。该研究的主要终点是球囊扩张后90分钟ST段回落水平，通过检测3个时间段（即90分钟前，90分钟和90分钟之后）的ECG。

      该研究的目的是比较在行直接PCI的SREMI患者中，弹丸注射替罗非班是否能够达到与阿昔单抗辅助疗法相同的心肌再灌注水平。

      结果显示：与阿昔单抗标准治疗患者相比，接受替罗非班治疗的患者并不能达到与之等效的临床结果。阿昔单抗治疗组中患者ST段完全回落比例比替罗非班治疗组高约3.4%。由意大利的Francesco Saia医生汇报了这一结果。

      “尽管3.4%的比例并不是很大，但是这种危险差别能够直接影响最终临床结果却是不容质疑的。先前已有研究证实阿昔单抗能够有助于提高直接PCI患者的血流灌注和左室功能，进而直接影响患者短期和长期预后，与阿昔单抗相比，替罗非班在大剂量(25 μg/kg)条件下，在注入之后10分钟，也能抑制90%以上的血小板聚集。”

尚待研究来证实……
      Saia说，我们还需要进一步研究来对比阿昔单抗和GP IIb/IIIa阻滞剂，来观察两类药物是否在不同类型患者中表现也不一样。进行这样的研究非常有必要，因为按照现在市场价格来算，即使是应用大剂量的替罗非班，它的花费也只是阿昔单抗的1/3。

(医心评论：马秀芹 译  陆卫 校）

Key Points:

• Patients treated with tirofiban were less likely to achieve ST resolution than those treated with abciximab.

By TCT Daily Staff

Tirofiban did not achieve equivalent efficacy vs. standard-therapy abciximab for the treatment of patients with STEMI, according to results from the FATA trial. The trial was designed to examine the equivalence between a high-dose bolus of tirofiban and abciximab as adjunctive therapy in patients with STEMI undergoing primary PCI in terms of achieving effective myocardial reperfusion.

About 3.4% more patients treated with abciximab (ReoPro, Eli Lilly) achieved complete ST resolution than those treated with tirofiban (Aggrastat, Medicure), said Francesco Saia, MD, PhD, from the University of Bologna in Italy (see Figure).

"The absolute difference in rates of complete ST resolution observed between abciximab and tirofiban was small – 3.4% – and the question whether this could translate into a different clinical benefit is legitimate," Saia said.

Previous research has demonstrated that abciximab can improve myocardial perfusion and left ventricular recovery after primary PCI, thus improving both early and late clinical outcome in these patients.

Tirofiban, when administered at a high dose (25 µg/kg), has been shown to achieve more than 90% platelet aggregation inhibition 10 minutes after infusion, comparable to inhibition of aggregation obtained with the standard dose of abciximab.

More research needed

Saia said further studies are needed to determine if there is a clinical difference between abciximab and other IIb/IIIa inhibitors, and whether these drugs have different profiles of efficacy in different patients. The study is important, he said, because at current market prices, treatment with a high-dose bolus of tirofiban costs about one-third of the cost of treatment with abciximab.

FATA included 680 patients aged 18 years or older who presented within six hours of STEMI onset and were undergoing primary PCI. Patients were randomized to two groups of equivalent sizes. The first group received abciximab at 0.25 mg/kg, followed by a 12-hr infusion of 0.125 µg/kg/min. The second group received tirofiban at 25 µg/kg, followed by an 18-hr infusion of 0.15 µg/kg/min.

The primary endpoint was the rate of complete ST-segment resolution at 90 minutes after first balloon inflation. ST resolution was calculated as the percent reduction in the summed ST elevation score between pre- and 90-min post-procedure ECG, and defined as complete at 70% reduction in score.

Disclosures:

（source：www.tctmd.com）