Clinical investigationIs there evidence of implicit exclusion criteria for elderly subjects in randomized trials? Evidence from the GUSTO-1 study☆
Section snippets
GUSTO
The GUSTO trial compared thrombolytic strategies for the treatment of AMI; all 4 treatment arms included at least 1 thrombolytic agent. The trial's eligibility criteria required that patients come to a participating hospital <6 hours after the onset of symptoms, with chest pain lasting at least 20 minutes and accompanied by electrocardiographic signs of ≥l 0.1 mV of ST-segment elevation in ≥2 limb leads or ≥l 0.2 mV in ≥2 contiguous precordial leads. The criteria for exclusion were previous
Patient characteristics
When we applied the GUSTO selection criteria as aforementioned, we found that 20,647 of the NRMI patients and 17,157 of the CCP patients would have been eligible for participation in GUSTO (Table I). The most common reasons why patients in CCP and NRMI would have been excluded from GUSTO were presentation >6 hours after symptom onset and the absence of chest pain or ST-segment elevation on admission.
Of the 41,021 patients who participated in GUSTO, many were <65 years of age (60%) or were
Discussion
Our comparison of patients in GUSTO with those in 2 large, national observational studies demonstrates several important findings. First, the proportion of elderly patients in the community setting who would have been eligible for the GUSTO trial is relatively small (10%–15% of potentially eligible patients), primarily because of 2 exclusion criteria: delayed presentation and the absence of suitable electrocardiographic findings. Among the subgroup of patients in NRMI and CCP who would have met
Acknowledgements
We thank the patients, investigators, and hospitals that participated in GUSTO, NRMI, and CCP.
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Dr Gross was supported by a Cancer Prevention, Control and Population Sciences Career Development Award (1K078CA-90402) and the Claude D. Pepper Older Americans Independence Center at Yale (P30AG21342).
The analyses on which this publication is based were performed under contract number 500-99-CT01, titled “Utilization and Quality Control Peer Review Organization for the State of Connecticut,” sponsored by the Centers for Medicare and Medicaid Services, Department of Health and Human Services. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does the mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. The author assumes full responsibility for the accuracy and completeness of the ideas presented. This article is a direct result of the Health Care Quality Improvement Program initiated by the Centers for Medicare and Medicaid Services, which has encouraged identification of quality improvement projects derived from analysis of patterns of care, and therefore required no special funding on the part of this contractor. Ideas and contributions to the author concerning experience in engaging with issues presented are welcomed.
Guest editor for this manuscript was A. Michael Lincoff, MD, Cleveland Clinic Foundation, Cleveland, Ohio.