Kastrati Adnan, Mehilli Julinda, Schühlen Helmut, Dirschinger Josef, Dotzer Franz, ten Berg Jurriën M, Neumann Franz-Josef, Bollwein Hildegard, Volmer Christian, Gawaz Meinrad, Berger Peter B, Schömig Albert
Deutsches Herzzentrum, Munich, Germany.
N Engl J Med. 2004 Jan 15;350(3):232-8. doi: 10.1056/NEJMoa031859.
Whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention after pretreatment with clopidogrel is unknown.
We enrolled 2159 patients with coronary artery disease who underwent a percutaneous coronary intervention: 1079 patients were randomly assigned in a double-blind manner to receive abciximab and 1080 patients to receive placebo. All patients were pretreated with a 600-mg dose of clopidogrel at least two hours before the procedure. The primary end point of the trial was the composite of death, myocardial infarction, and urgent target-vessel revascularization within 30 days after randomization.
The incidence of the primary end point was 4 percent (45 patients) in the abciximab group, as compared with 4 percent (43 patients) in the placebo group (relative risk, 1.05; 95 percent confidence interval, 0.69 to 1.59; P=0.82). Most adverse events were myocardial infarctions: the incidence was 4 percent (40 patients) in the abciximab group and 4 percent (41 patients) in the placebo group (P=0.91). Twelve patients (1 percent) in the abciximab group and eight patients (1 percent) in the placebo group had major bleeding complications (P=0.37). Profound thrombocytopenia occurred in 10 patients (1 percent) in the abciximab group but in none in the placebo group (P=0.002).
Our data suggest that in patients at low-to-intermediate risk who undergo elective percutaneous coronary intervention after pretreatment with a high loading dose of clopidogrel, abciximab is associated with no clinically measurable benefit within the first 30 days.
在接受氯吡格雷预处理后行择期经皮冠状动脉介入治疗的患者中，糖蛋白IIb/IIIa抑制剂阿昔单抗是否有益尚不清楚。
我们纳入了2159例行经皮冠状动脉介入治疗的冠心病患者：1079例患者以双盲方式随机分配接受阿昔单抗治疗，1080例患者接受安慰剂治疗。所有患者在手术前至少两小时接受600mg剂量的氯吡格雷预处理。试验的主要终点是随机分组后30天内死亡、心肌梗死和紧急靶血管血运重建的复合终点。
阿昔单抗组主要终点的发生率为4%（45例患者），而安慰剂组为4%（43例患者）（相对风险，1.05；95%置信区间，0.69至1.59；P=0.82）。大多数不良事件为心肌梗死：阿昔单抗组的发生率为4%（40例患者），安慰剂组为4%（41例患者）（P=0.91）。阿昔单抗组有12例患者（1%）发生严重出血并发症，安慰剂组有8例患者（1%）发生严重出血并发症（P=0.37）。阿昔单抗组有10例患者（1%）发生严重血小板减少症，而安慰剂组无1例发生（P=0.002）。
我们的数据表明，在接受高负荷剂量氯吡格雷预处理后行择期经皮冠状动脉介入治疗的低至中度风险患者中，阿昔单抗在最初30天内未显示出可临床测量的益处。
