van den Brand M J, Simoons M L, de Boer M J, van Miltenburg A, van der Wieken L R, de Feyter P J
Thoraxcenter, Erasmus University and University Hospital Dijkzigt, Rotterdam, NL.
Eur Heart J. 1995 Nov;16 Suppl L:36-42. doi: 10.1093/eurheartj/16.suppl_l.36.
Patients with unstable angina, refractory to intensive medical therapy, are at high risk of developing thrombotic complications, such as myocardial infarction and coronary occlusion during coronary angioplasty. As platelet aggregation and thrombus formation play an important role in this ongoing ischaemic process, a monoclonal platelet GPIIb/IIIa receptor antibody (c7E3) has been designed to modify the clinical course and underlying coronary lesion morphology. To evaluate whether c7E3 could influence the incidence of complications, we randomized 60 patients to c7E3 or placebo after initial angiography had demonstrated a culprit lesion amenable for angioplasty. All patients exhibited dynamic ECG changes and recurrent pain attacks, despite intensive medical therapy. After study drug bolus and infusion, angiography was repeated and angioplasty performed. Recurrent ischaemia during study drug infusion occurred in nine and 16 patients from the c7E3 and placebo groups, respectively (P = 0.06). Major events defined as death, myocardial infarction or urgent intervention occurred in one and seven patients, respectively (P = 0.03). One patient from the placebo group died as a result of recurrent infarction. Resolution of clots was only observed in the c7E3 group, combined with improvement in TIMI flow grade in 20% of patients. Quantitative angiography showed an improvement in percentage diameter stenosis in the c7E3 group, which was not observed in the placebo group, although the difference between the two treatment groups was not significant. No excess bleeding was observed in the treatment group. Thus, c7E3 bolus and infusion, combined with heparin and aspirin improved the clinical course, the coronary lesion morphology and rheology in patients with unstable angina, refractory to medical treatment.
强化药物治疗无效的不稳定型心绞痛患者发生血栓并发症的风险很高，如在冠状动脉血管成形术期间发生心肌梗死和冠状动脉闭塞。由于血小板聚集和血栓形成在这一持续的缺血过程中起重要作用，一种单克隆血小板糖蛋白IIb/IIIa受体抗体（c7E3）已被设计用于改变临床病程和潜在的冠状动脉病变形态。为了评估c7E3是否会影响并发症的发生率，在初始血管造影显示有适合血管成形术的罪犯病变后，我们将60例患者随机分为c7E3组或安慰剂组。尽管进行了强化药物治疗，但所有患者均出现动态心电图变化和反复疼痛发作。在给予研究药物推注和输注后，重复进行血管造影并实施血管成形术。c7E3组和安慰剂组分别有9例和16例患者在研究药物输注期间出现反复缺血（P = 0.06）。定义为死亡、心肌梗死或紧急干预的主要事件分别发生在1例和7例患者中（P = 0.03）。安慰剂组有1例患者因反复梗死死亡。仅在c7E3组观察到血栓溶解，20%的患者TIMI血流分级有所改善。定量血管造影显示c7E3组的直径狭窄百分比有所改善，安慰剂组未观察到这种情况，尽管两个治疗组之间的差异不显著。治疗组未观察到额外出血。因此，c7E3推注和输注联合肝素和阿司匹林改善了药物治疗无效的不稳定型心绞痛患者的临床病程、冠状动脉病变形态和流变学。
