Bertrand Olivier F, Rodés-Cabau Josep, Larose Eric, Nguyen Can Manh, Déry Jean-Pierre, Proulx Guy, Roy Louis, Poirier Paul, Costerousse Olivier, De Larochellière Robert
Hôpital Laval, Institut Universitaire de Cardiologie et de Pneumologie, Canada.
Int J Cardiol. 2009 Aug 14;136(2):165-70. doi: 10.1016/j.ijcard.2008.04.073. Epub 2008 Jul 25.
In the EASY trial, we have shown the clinical equivalence between abciximab bolus-only and abciximab bolus followed by 12-h infusion in a wide spectrum of patients after percutaneous coronary intervention (PCI). Some reports have suggested better outcomes following intracoronary (IC) abciximab administration compared to intravenous (IV) delivery. We sought to compare cardiac biomarkers release and early and late clinical outcomes after IC or IV abciximab bolus delivery.
From 1005 patients randomized in the EASY trial and undergoing transradial coronary stent implantation, 208 received IC abciximab bolus and 797 received IV abciximab bolus. Route of administration was left to operators' discretion. Creatine Kinase-MB, and Troponin-T (Tn-T) were obtained immediately prior to angiography, 4-6 h after PCI and the next day. MACE (death, MI, TVR) rate was evaluated at 30 days, 6 months and 12 months.
There were more patients with acute coronary syndrome (75% vs 64%, P=0.004) and previous MI (53% vs 42%, P=0.005) in the IC group and more patients with >or=3 dilated sites in the IV group (2% IC vs 7% IV, P=0.03). After PCI, the extent of Tn-T and CK-MB release remained comparable in both groups. The MACE rate was 2% in both groups at 30 days, 9% in IC bolus vs 5% in IV bolus (P=0.04) at 6 months and 10% in IC bolus vs 9% in IV bolus (P=0.50) at 12 months. By multivariate analysis, IC abciximab bolus was not associated with better outcomes at 12 months compared to IV bolus (HR 1.07, 95% CI 0.82-1.35, P=0.62).
Compared to IV abciximab administration, IC abciximab was not associated with less cardiac biomarkers release or better clinical outcomes after uncomplicated transradial PCI. Further studies are required in clinical scenarios including patients with higher thrombotic burden and/or occluded vessels as in primary and rescue PCI.
在EASY试验中,我们已证实在经皮冠状动脉介入治疗(PCI)后的广泛患者群体中,仅使用阿昔单抗推注与阿昔单抗推注后再进行12小时输注在临床效果上相当。一些报告表明,与静脉内(IV)给药相比,冠状动脉内(IC)给予阿昔单抗后的结果更好。我们试图比较冠状动脉内或静脉内推注阿昔单抗后心脏生物标志物的释放情况以及早期和晚期临床结果。
在EASY试验中随机分组并接受经桡动脉冠状动脉支架植入的1005例患者中,208例接受冠状动脉内阿昔单抗推注,797例接受静脉内阿昔单抗推注。给药途径由操作者自行决定。在血管造影术前、PCI后4 - 6小时及次日获取肌酸激酶同工酶(CK - MB)和肌钙蛋白T(Tn - T)。在30天、6个月和12个月时评估主要不良心血管事件(MACE,包括死亡、心肌梗死、靶血管重建)发生率。
冠状动脉内组急性冠状动脉综合征患者更多(75%对64%,P = 0.004),既往有心肌梗死的患者更多(53%对42%,P = 0.005);静脉内组有≥3个扩张部位的患者更多(冠状动脉内组2%对静脉内组7%,P = 0.03)。PCI后,两组肌钙蛋白T和CK - MB的释放程度仍相当。30天时两组MACE发生率均为2%;6个月时,冠状动脉内推注组为9%,静脉内推注组为5%(P = 0.04);12个月时,冠状动脉内推注组为10%,静脉内推注组为9%(P = 0.50)。多因素分析显示,与静脉内推注相比,12个月时冠状动脉内推注阿昔单抗与更好的结果无关(风险比1.07,95%置信区间0.82 - 1.35,P = 0.62)。
与静脉内给予阿昔单抗相比,在无并发症的经桡动脉PCI后,冠状动脉内给予阿昔单抗与更少的心脏生物标志物释放或更好的临床结果无关。在包括血栓负荷较高和/或血管闭塞患者(如在直接PCI和补救性PCI中)的临床情况下,还需要进一步研究。