Representation of older adults in the late-breaking clinical trials American Heart Association 2011 Scientific Sessions.

R To the Editor: Increasingly, the practice of medicine has relied on pplicable and available evidence to deliver quality care. Cardioascular medicine has led the way using numerous clinical trials as he basis of clinical practice guidelines. However, despite the strong ssociation of aging with the development of cardiovascular disease, andomized clinical trials rarely enroll a substantial proportion of older dults, leading experts to question the applicability of the evidence ase to the typical patient with cardiovascular disease (1). We sought to document the inclusion of older adults in contemporary highprofile, recently conducted clinical trial populations in cardiovascular disease and compare the age characteristics of the clinical trials with the age characteristics of the diseases being studied. All late-breaking clinical trials (LBCTs) at the 2011 American Heart Association (AHA) Scientific Sessions were included in this study (2). For each LBCT, a brief summary of the important results, with all available age information, was extracted. This represented inclusion or exclusion characteristics on the basis of age and the age information of the baseline characteristic (means, medians, and proportions above and below age cut points). The LBCTs were divided into disease-based categories, and results were tabulated by category. When available, the published report for each LBCT was used. In cases in which the reports were not published, information was obtained from the LBCT slide set on the AHA Web site (2) and supplemented with information from ClinicalTrials.gov as needed. To compare the clinical trial cohort with the community population, the prevalence of older adults in each disease category was ascertained. The 22 LBCTs at the 2011 AHA Scientific Sessions were divided by category: coronary artery disease (5 trials), acute coronary syndromes (5), chronic heart failure (3), atrial fibrillation (3), cardiac surgery and intervention (4), peripheral artery disease (1), and venous thromboembolism (1). Among those trials, 8 did not include older adults (age 60 to 80 years, depending on the study). In trials in which the percents of older adults were available, adults age 75 years constituted 9% to 55% of the enrolled subjects. In the remaining trials, the mean age was 54 to 66 years. This contrasts with the prevalence of older age among those with cardiovascular diseases in the general population, in which older adults represent one-third to one-half of patients with the cardiovascular diseases studied in these trials. See Table 1 (3–25) for details. With aging of the United States population and the evolving emographics of cardiovascular disease, we reviewed the LBCTs at he 2011 AHA Scientific Sessions to determine the ages of enrolled ubjects and, when available, the percent of older adults included each rial. Our findings show that in the current era of clinical cardiovasular research, the demographics of those enrolled in the LBCTs are nconsistent with those of the community population and inadeuately represent older adults with cardiovascular disease.