Increasing Diversity in Clinical Trials with PLATINUM Diversity: Outcomes with the Promus PREMIER™ Stent in Women and Minorities

PLATINUM Diversity is a first-of-its-kind study focused solely on women and minorities, groups that are less likely to be included in cardiology studies. The study will help health care providers understand how a variety of factors affect patient outcomes one year after a stent is implanted. These factors include income, marital status, education, living/working conditions, access to and use of health care, and language agreement.

The study found that women and minority men are at increased risk of cardiac events compared to white men. Risk factors for heart disease such as diabetes and hypertension were higher in women and minority men than in white men. Where income was reported, there appeared to be a relationship between higher incomes and lower risk of death, myocardial infarction (MI) and target vessel revascularization (TVR).

The PLATINUM Diversity Study is an example of Boston Scientific’s commitment to promoting health equity, raising awareness and increasing access to health care. It is aligned with Close the Gap’s mission to eliminate cardiovascular care disparities, and to improve health service access to all patients, regardless of age, gender, race, ethnicity or primary language.

Why Now? The Lack of Diversity in Data

The United States has always been a melting pot of cultures and ethnicities, and that diversity continues to grow at a rapid pace. However, there is very little clinical data that details the outcomes of medical devices in women and people of color.

According to the U.S. Centers for Disease Control and Prevention (CDC), cardiovascular disease is the leading cause of death for all Americans, including women and minorities.1 Despite this reality, women represent less than one-third of those in cardiovascular clinical trials conducted since 20062; while African Americans represent about 12 percent of the U.S. population, they comprise just five percent of patients in clinical trials.3

In an effort to lead the way in establishing best practices for collecting clinical data regarding medical devices in diverse patient populations, the PLATINUM Diversity study follows the guidance issued by the FDA for the collection of gender-specific data in clinical trials.

At Boston Scientific, we know that the more clinical evidence that is generated for patients who have historically been underrepresented in clinical trials, the better positioned we are to meet the needs of an ever-more diverse patient population.

About Close the Gap

Close the Gap is a Boston Scientific solution-oriented health equity initiative that aims to help everyone have access to the highest quality cardiovascular care regardless of race, ethnicity or gender. To learn more about Close the Gap, visit http://www.YourHeartHealth.com.