Cohen M, Parry G, Adams P C, Xiong J, Chamberlain D, Wieczorek I, Fox K A, Kronmal R, Fuster V
Department of Medicine, Hahnemann University Hospital, Philadelphia, Pennsylvania.
Eur Heart J. 1994 Sep;15(9):1196-203. doi: 10.1093/oxfordjournals.eurheartj.a060653.
The aim of this trial was to compare the efficacy of combination antithrombotic therapy with a prostacyclin-sparing aspirin plus anticoagulation versus conventional aspirin plus anticoagulation, when added to antianginal therapy, in patients with unstable angina or non-Q wave myocardial infarction already being treated with aspirin. In a double-blind (for the aspirin) study, 144 prior aspirin users were randomized; 72 patients received controlled-release, prostacyclin-sparing aspirin 75 mg daily plus anticoagulation (intravenous heparin followed by warfarin to maintain the international normalized ratio at 2-3), and 72 patients received conventional aspirin 75 mg daily plus the same anticoagulation. Controlled-release aspirin was formulated to preserve endothelial cell prostacyclin synthesis. Trial therapy was begun by 13.2 +/- 12.3 h of qualifying pain, and continued for 12 weeks. The frequency of recurrent angina with electrocardiographic changes, myocardial infarction, or death, was analysed by intention to treat. At 12 weeks, events were: [table: see text] Twenty-six of the 42 (62%) recurrent ischaemic events occurred within 7 days of presentation. Four of the 144 patients (3%) experienced a major bleeding complication. It is concluded that in spite of maximal antithrombotic therapy, there is a significant failure rate of medical therapy in aspirin users presenting with unstable angina or non-Q wave myocardial infarction while at rest. Prostacyclin-sparing aspirin offers no clinical benefit over conventional aspirin.
本试验的目的是比较在已接受阿司匹林治疗的不稳定型心绞痛或非Q波心肌梗死患者中，在抗心绞痛治疗基础上加用前列环素 sparing 阿司匹林联合抗凝治疗与传统阿司匹林联合抗凝治疗的疗效。在一项双盲（针对阿司匹林）研究中，144 名既往使用过阿司匹林的患者被随机分组；72 名患者接受每日 75 毫克控释、前列环素 sparing 阿司匹林加抗凝治疗（静脉注射肝素，随后使用华法林维持国际标准化比值在 2 - 3），72 名患者接受每日 75 毫克传统阿司匹林加相同的抗凝治疗。控释阿司匹林的配方旨在保留内皮细胞前列环素的合成。试验治疗在符合条件的疼痛出现后 13.2±12.3 小时开始，并持续 12 周。通过意向性分析复发性心绞痛伴心电图改变、心肌梗死或死亡的频率。在 12 周时，事件如下：[表格：见原文]42 例复发性缺血事件中有 26 例（62%）在就诊后 7 天内发生。144 名患者中有 4 名（3%）经历了严重出血并发症。得出的结论是，尽管进行了最大程度的抗血栓治疗，但在休息时出现不稳定型心绞痛或非Q波心肌梗死的阿司匹林使用者中，药物治疗仍有显著的失败率。前列环素 sparing 阿司匹林相较于传统阿司匹林并无临床益处。
