Statement Calls For More Inclusion of Older Patients in CV Clinical Trials
There is a critical need for more large, population-based studies and clinical trials that include adults older than 75 years with complex comorbidities and other issues, according to a scientific statement released April 11 by the ACC, in conjunction with the American Heart Association (AHA) and the American Geriatrics Society, and published in the Journal of the American College of Cardiology.
“The incidence and prevalence of most cardiovascular disorders increase with age, and cardiovascular disease is the leading cause of death and major disability in adults ≥75 years of age,” the statement’s authors explain, “however … patients aged ≥75 have been markedly underrepresented in most major cardiovascular trials.” In addition, nearly all trials fail to include older patients with complex comorbidities, significant cognitive or physical disabilities, frailty, or residence in a nursing home or assisted living facility. This exclusion has resulted in a lack of evidence-based recommendations for the diagnosis and treatment of older patients – patients who make up the majority of routine clinical practice.
In a review of the ACC, AHA, and American Stroke Association guidelines, the statement’s authors found “a pervasive lack of evidence to guide clinical decision making in older patients with cardiovascular disease.” The statement contains detailed recommendations to close knowledge gaps in current guidelines for coronary artery disease, stable ischemic heart disease, percutaneous coronary intervention, and coronary artery bypass surgery, ventricular arrhythmias and sudden cardiac death, heart rhythm disorders, heart failure and more.
“There is a fundamental shift in the balance of risk and benefit in older patients that has been inadequately addressed in clinical trials,” the authors said. To overcome these deficiencies in knowledge and evidence, moving forward, the statement recommends a multitude of large population-based studies and clinical trials that use novel study designs to include patient-centered outcomes relevant to older patients. These studies must include a “broad mix” of patients representative of those typically seen in clinical practice. According to the authors, increasing these studies will help transform care and improve outcomes for the growing population of older patients with cardiovascular disease.
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