Boston Scientific has initiated a new study of its second-generation everolimus-eluting coronary stent (Promus Premier) to evaluate its use in the management of coronary artery disease in in under-served patient populations, including women, African Americans, Latinos/Hispanics, Native Americans and Alaska Natives.
A company press release reports that historically, large-scale clinical trials in cardiology have had a disproportionately low inclusion of women and non-white patients. As a result, physicians have had little data on which to base their clinical decisions when treating these patients. It adds that the new PLATINUM Diversity trial is aligned with recent actions taken by the FDA, (including implementation of FDASIA 907: Inclusion of Demographic Subgroups in Clinical Trials) and with the Boston Scientific Close the Gap education initiative, which aims to promote health equity and ensure all patients receive optimal health care regardless of age, gender, race, ethnicity or primary language.
The trial is an observational, prospective, multicentre, open-label, single-arm, post-approval study that will enroll up to 1,500 patients from understudied populations, specifically women, black Americans, Latinos/Hispanics, American Indians or Alaska Natives, at up to 65 sites in the U.S. The primary study endpoint is the rate of the composite of death, myocardial infarction and target vessel revascularization through 12 months. Initial data are expected to be available in 2016.
Principal investigator Roxana Mehran (director of Interventional Cardiovascular Research and Clinical Trials, Icahn School of Medicine at Mount Sinai Medical Center, New York, USA) says: “Creating a treatment plan specifically tailored to underrepresented populations has long been a challenge in clinical practice due to the lack of specific outcomes data from cardiovascular clinical trials. I am excited to be part of a trial that aims to fill the data demographic gap in the stent space and provides physicians with additional knowledge to make the best treatment decisions possible for their patients.”