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New PLATINUM DIVERSITY Study Focuses on Women, Minorities
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Boston Scientific recently announced the launch of a trial that will evaluate the clinical performance of an everolimus-eluting stent in women and minority patients.
The PLATINUM Diversity study is an observational, prospective, multicenter, open-label, single-arm, postapproval study designed to enroll up to 1,500 patients. Those enrolled are from underserved populations, including women, black, Hispanics/Latinos, American Indians and Alaska Natives. All will receive the Promus Premier EES. The primary endpoint is a composite of death, MI and target vessel revascularization at 12 months, according to a press release.
Women represent less than one-third of patients enrolled in CV trials since 2006, and black Americans represent just 5% of patients enrolled in US clinical trials despite comprising 12% of the US population, according to the release.
Previous limitations
“One of the biggest — and most important — limitations to so many of the studies that we perform is that the African-American population, the Latino population and women are almost always underrepresented, and represent 25% or less of the population in our clinical trials,” principal investigator Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI, professor of medicine at Icahn School of Medicine at Mount Sinai, said in an interview. “To have a trial that is dedicated only to those patients … is unprecedented and incredibly important.”
Roxana
Mehran
The researchers will also collect demographic information such as educational background and socioeconomic status, ability to follow-up and adherence to medications after PCI, according to Mehran, who is Associate Medical Editor of Cardiology Today’s Intervention. Minority patients are more likely to be uninsured than white patients, which can mean that “their ability to follow-up is extremely hindered by the fact that they have not the funds nor the ability to adhere to their medications,” she said.
For Latino patients, the language barrier may be a factor in adherence to medication regimens and other instructions. So, every site participating in the PLATINUM Diversity trial is required to have a Spanish-speaking investigator, and every Spanish-speaking patient will receive consent forms, educational materials and instructions in Spanish, Mehran said.
The question is, “just by making these small changes, can we make an important impact on the follow-up of these patients?” she asked.
Understanding predictors
Researchers will also look to confirm previous findings detected in subgroup analyses. For example, “we have known for decades that women have more vascular complications in certain settings, especially in STEMI; they usually have higher mortality; they are usually older; and they usually have many more comorbidities by the time they present to the hospital. So whenever you compare them to men, they are not really comparable,” Mehran said. “In this way, we will be able to compare them to [other women] to understand what are some of the most important predictors amongst women and how we can improve outcomes.”
The first data from the study are expected to be available in 2016, according to the release. – by Erik Swain
Disclosure: Mehran reports financial ties with Abbott Laboratories, AstraZeneca, Boston Scientific, Bristol-Myers Squibb, CSL Behring, Covidien, Janssen Pharmaceuticals, Maya Medical, Merck, Sanofi Aventis and The Medicines Company.