Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI.
Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI.
复制标题
研究者经常未能遵守心电图进入标准，并影响临床结果：APEX-AMI 的教训。
DOI：
10.1093/eurheartj/ehm453
复制
发表时间：
2007
影响因子：
39.3
通讯作者：
P. Armstrong
中科院分区：
文献类型：
--
作者：
M. Tjandrawidjaja;Yuling Fu;H. Al;Thomas G. Todaro;P. Adams;F. Van de Werf;C. Granger;P. Armstrong
旨在
在急性心肌梗死（APEX-AMI）试验中评估培塞珠单抗评估中，检查ST段抬高型心肌梗死患者遵守心电图（ECG）入选标准的程度及其对临床结局的影响。
方法和结果
我们检查了入组APEX-AMI试验但不符合试验ECG入选标准的患者的频率、特征和结局。在分析的5615例患者中，28.8%不符合ECG入选标准：高风险下壁心肌梗死患者的发生率是其他心肌梗死患者的两倍多（42.3% vs. 19.3%，P < 0.001）。无论梗死位置如何，不符合心电图入选标准的患者死亡率显着降低（30天时2.5 vs. 4.5%，90天时3.1 vs. 5.3%;均P < 0.001）和死亡、心源性休克或CHF的复合发生率（30天时5.8 vs. 10.3%，90天时6.9 vs. 11.4%;均P < 0.001）。
结论
在APEX-AMI中，超过四分之一的入组患者不符合ECG入选标准，并且结局优于合格患者。虽然试验的主要结果不受基线ECG标准的影响，但我们的发现可能对设计未来的试验具有重要意义。
AIMS
To examine the extent and impact on clinical outcomes of adherence to electrocardiogram (ECG) entry criteria in ST-elevation myocardial infarction patients in the assessment of pexelizumab in acute myocardial infarction (APEX-AMI) trial.
METHODS AND RESULTS
We examined the frequency, characteristics, and outcomes of patients enrolled in APEX-AMI trial who did not meet the trial ECG entry criteria. Among 5615 patients analysed, 28.8% did not meet ECG entry criteria: this occurred more than twice as frequently amongst those with high-risk inferior vs. those with other MI (42.3 vs. 19.3%, P < 0.001). Regardless of infarct location, patients who failed to meet ECG entry criteria had significantly lower mortality (2.5 vs. 4.5% at 30 days and 3.1 vs. 5.3% at 90 days; both P < 0.001) and the composite rate of death, cardiogenic shock, or CHF (5.8 vs. 10.3% at 30 days and 6.9 vs. 11.4% at 90 days; both P < 0.001) as compared to those who met criteria.
CONCLUSION
In APEX-AMI over one-quarter of enrolled patients did not meet ECG entry criteria and had better outcomes than eligible patients. Although the trial's primary result was unaffected by alignment with the baseline ECG criteria, our findings may have important implications in designing future trials.
DOI：
10.1016/s0002-9149(83)80069-1
发表时间：
1983-02
期刊：
The American journal of cardiology
影响因子：
--
作者：
R. Ward;R. White;R. Ideker;N. Hindman;D. Alonso;S. Bishop;C. Bloor;J. Fallon;G. Gottlieb;D. Hackel
通讯作者：
R. Ward;R. White;R. Ideker;N. Hindman;D. Alonso;S. Bishop;C. Bloor;J. Fallon;G. Gottlieb;D. Hackel
下壁急性心肌梗死时心前区 ST 段压低的预后意义。
DOI：
10.1016/0002-9149(85)90369-8
发表时间：
1985
期刊：
The American journal of cardiology
影响因子：
--
作者：
Hlatky,MA;Califf,RM;Lee,KL;Pryor,DB;Wagner,GS;Rosati,RA
通讯作者：
Rosati,RA