Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes:: a meta-analysis of all major randomised clinical trials
Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes:: a meta-analysis of all major randomised clinical trials
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DOI：
10.1016/s0140-6736(02)07442-1
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发表时间：
2002-01-19
期刊：
影响因子：
168.9
通讯作者：
Simoons, ML
中科院分区：
文献类型：
--
作者：
Boersma, E;Harrington, RA;Simoons, ML
背景 血小板糖蛋白 IIb/IIIa 抑制剂已被证明可以减少接受经皮冠状动脉介入治疗的患者的心脏并发症。然而，这些药物在急性冠状动脉综合征中的临床疗效仍不清楚。我们对所有大型随机试验进行了荟萃分析，旨在研究糖蛋白 IIb/IIIa 抑制剂对未常规安排接受早期冠状动脉血运重建的急性冠脉综合征患者的临床疗效和安全性。方法纳入标准为：随机分组但无持续 ST 抬高的急性冠脉综合征患者；比较 糖蛋白 IIb/IIIa 抑制剂联合安慰剂或对照治疗；不建议在研究药物输注期间进行早期冠状动脉血运重建；并招募至少 1000 名患者。从这些试验的所有参与者处获得了个体患者的数据。结果 六项试验纳入了 31402 名患者，符合纳入标准。随机分组后 30 天，3530 名患者 (11.2%) 死亡或发生心肌梗死。第 30 天，与安慰剂或对照相比，糖蛋白 IIb/IIIa 抑制剂的死亡或心肌梗塞几率降低了 9%（事件发生率为 10.8% [1980/18297] vs 11.8% [1550/13105]；比值比 0.91 [95% CI 0.84-0.98]；p=0.015）。根据重要的临床基线特征，患者亚组的相对治疗获益相似；因此，高危患者的绝对治疗获益最大。在性别和分配的治疗之间发现了意想不到的显着相互作用，男性有治疗获益（0.81 [0.75-0.89]，但女性没有治疗获益（1.15 [1.01-1.30]）。然而，一旦根据肌钙蛋白浓度对患者进行分层，就没有证据表明治疗反应存在性别差异，并且肌钙蛋白浓度升高的男性和女性风险降低。主要出血并发症增加 糖蛋白 IIb/IIIa 抑制剂（2.4% [445/18297] vs 1.4% [180/13105]；p
Background Platelet glycoprotein IIb/IIIa inhibitors have been shown to reduce cardiac complications in patients undergoing percutaneous coronary intervention. The clinical efficacy of these drugs in acute coronary syndromes, however, is still unclear. We did a meta-analysis of all large randomised trials designed to study the clinical efficacy and safety of glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes who were not routinely scheduled to undergo early coronary revascularisation.Methods Inclusion criteria were: randomisation of patients with acute coronary syndromes but without persistent ST elevation;l comparison of a glycoprotein IIb/IIIa inhibitor with placebo or control therapy; non-recommendation of early coronary revascularisation during study-drug infusion; and enrollment of at least 1000 patients. Data on individual patients were obtained from all participants in these trials.Findings Six trials, enrolling 31402 patients, fulfilled the inclusion criteria. 30 days after randomisation, 3530 (11.2%) patients died or developed a myocardial infarction. At:30 days, a 9% reduction in the odds of death or myocardial infarction was seen with glycoprotein IIb/IIIa inhibitors compared with placebo or control (10.8% [1980/18297] vs 11.8% [1550/13105] events; odds ratio 0.91 [95% CI 0.84-0.98]; p=0.015). The relative treatment benefit was similar in subgroups of patients according to important clinical baseline characteristics; hence, the absolute treatment benefit was largest in high-risk patients. An unexpected and significant interaction was seen between sex and allocated treatment, with a treatment benefit in men (0.81 [0.75-0.89] but not in women (1.15 [1.01-1.30]). However, once patients were stratified according to troponin concentration, there was no evidence of a sex difference in treatment response, and a risk reduction was seen in men and women with raised troponin concentrations. Major bleeding complications were increased by glycoprotein IIb/IIIa inhibitors (2.4% [445/18297] vs 1.4% [180/13105]; p