In a randomized controlled trial, published in Contemporary Clinical Trials, researchers assessed whether the characteristics in cohorts of patients with peripheral artery disease (PAD) among randomized clinical trials (RCTs) are representative of real-world populations of patients with PAD. According to the study’s primary author, Lindsey E. Scierka, from the Vascular Medicine Outcomes Program of the Section of Cardiovascular Medicine in the Department of Internal Medicine at Yale University in Connecticut, USA, “real-world patients with PAD were older and sicker when compared to an RCT with similar indications.”
These findings were based on a comparison of 879 patients’ baseline characteristics and health statuses, assessed via the Peripheral Artery Questionnaire (PAQ), from the CLEVER clinical trial cohort (n = 119) or the PORTRAIT real-world registry (n = 760).
According to the article, “while CLEVER enrolled patients with aortoiliac disease, only 16.0% of the PORTRAIT cohort had isolated aortoiliac disease.” Both cohorts of patients had similar disease-specific health statuses based on PAQ scores. Notably, patients from PORTRAIT were older, had more severe disease, and had a higher incidence of cardiovascular risk factors, “including hyperlipidemia and diabetes,” when compared to CLEVER trial participants.
Ultimately, the authors presented their data as evidence of a gap in characteristics between clinical trial and real-world patients with PAD. In their conclusion, they suggested that “this gap may be bridged by improving enrollment of underrepresented high-risk patients in PAD trials testing strategies for PAD symptom relief.”
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