N Engl J Med. 1994 Apr 7;330(14):956-61. doi: 10.1056/NEJM199404073301402.
Platelets are believed to play a part in the ischemic complications of coronary angioplasty, such as abrupt closure of the coronary vessel during or soon after the procedure. Accordingly, we evaluated the effect of a chimeric monoclonal-antibody Fab fragment (c7E3 Fab) directed against the platelet glycoprotein IIb/IIIa receptor, in patients undergoing angioplasty who were at high risk for ischemic complications. This receptor is the final common pathway for platelet aggregation.
In a prospective, randomized, double-blind trial, 2099 patients treated at 56 centers received a bolus and an infusion of placebo, a bolus of c7E3 Fab and an infusion of placebo, or a bolus and an infusion of c7E3 Fab. They were scheduled to undergo coronary angioplasty or atherectomy in high-risk clinical situations involving severe unstable angina, evolving acute myocardial infarction, or high-risk coronary morphologic characteristics. The primary study end point consisted of any of the following: death, nonfatal myocardial infarction, unplanned surgical revascularization, unplanned repeat percutaneous procedure, unplanned implantation of a coronary stent, or insertion of an intraaortic balloon pump for refractory ischemia. The numbers of end-point events were tabulated for 30 days after randomization.
As compared with placebo, the c7E3 Fab bolus and infusion resulted in a 35 percent reduction in the rate of the primary end point (12.8 vs. 8.3 percent, P = 0.008), whereas a 10 percent reduction was observed with the c7E3 Fab bolus alone (12.8 vs. 11.5 percent, P = 0.43). The reduction in the number of events with the c7E3 Fab bolus and infusion was consistent across the end points of unplanned revascularization procedures and nonfatal myocardial infarction. Bleeding episodes and transfusions were more frequent in the group given the c7E3 Fab bolus and infusion than in the other two groups.
Ischemic complications of coronary angioplasty and atherectomy were reduced with a monoclonal antibody directed against the platelet IIb/IIIa glycoprotein receptor, although the risk of bleeding was increased.
血小板被认为在冠状动脉血管成形术的缺血性并发症中起作用，例如在手术期间或术后不久冠状动脉血管突然闭塞。因此，我们评估了一种针对血小板糖蛋白IIb/IIIa受体的嵌合单克隆抗体Fab片段（c7E3 Fab）对有缺血性并发症高风险的血管成形术患者的影响。该受体是血小板聚集的最终共同途径。
在一项前瞻性、随机、双盲试验中，56个中心的2099例患者接受了推注和输注安慰剂、推注c7E3 Fab和输注安慰剂，或推注和输注c7E3 Fab。他们计划在涉及严重不稳定型心绞痛、进展性急性心肌梗死或高危冠状动脉形态特征的高危临床情况下接受冠状动脉血管成形术或旋切术。主要研究终点包括以下任何一项：死亡、非致命性心肌梗死、非计划的外科血管重建、非计划的重复经皮手术、非计划的冠状动脉支架植入，或因难治性缺血而插入主动脉内球囊泵。随机分组后30天记录终点事件的数量。
与安慰剂相比，推注和输注c7E3 Fab使主要终点发生率降低了35%（12.8%对8.3%，P = 0.008），而单独推注c7E3 Fab仅使发生率降低了10%（12.8%对11.5%，P = 0.43）。推注和输注c7E3 Fab导致的事件数量减少在非计划血管重建手术和非致命性心肌梗死的终点中是一致的。接受推注和输注c7E3 Fab的组中出血事件和输血比其他两组更频繁。
尽管出血风险增加，但针对血小板IIb/IIIa糖蛋白受体的单克隆抗体可降低冠状动脉血管成形术和旋切术的缺血性并发症。
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