As part of the commitment to support health equity for all patients, Boston Scientific Corporation sponsored the PLATINUM Diversity study to evaluate the clinical outcomes of the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System in women and minorities. The clinical endpoints were presented today at the 28th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
In this study, there were no significant outcome differences between white men and women or minorities for the composite primary endpoint of death, myocardial infarction (MI) or target vessel revascularization (TVR) at 12 months. The composite death/MI/TVR rate was 7.6 percent for white men compared to 8.6 percent for women (p=0.33), and 9.6 percent for minorities (p=0.08). Additionally, secondary endpoint results were as follows (differences with p<0.05 were statistically significant):
* All-cause death: 2.2 percent for white men compared to 3.4 percent for women (p=0.04), and 3.7 percent for minorities (p=0.03).
* MI: 1.1 percent for white men compared to 1.9 percent for women (p=0.06), and 3.1 percent for minorities (p=0.0002).
* TVR: 5.5 percent for white men compared to 4.6 percent for women (p=0.27), and 5.4 percent for minorities (p=0.97)
* Definite or probable stent thrombosis: 0.7 percent for white men compared to 0.9 percent for women (p=0.55), and 1.2 percent for minorities (p=0.22).
"Most clinical trials examine how any given treatment impacts patient outcomes; however, given that much of an individual's health is determined by non-clinical factors, we thought it important to design the PLATINUM Diversity study in order to better understand the nature and magnitude of outcome disparities that exist for under-represented groups after contemporary coronary stent procedures," said Wayne Batchelor, M.D., co-principal investigator and chair of the Interventional Cardiology Council at Tallahassee Memorial Hospital, Tallahassee, Florida.
"The initial evaluation of the primary endpoint is the first of many analyses that we believe will provide invaluable insights into the social, behavioral and economic determinants of health in women and minorities who undergo coronary stent procedures," said Roxana Mehran, M.D., co-principal investigator and director of the Office of Interventional Cardiovascular Research and Clinical Trials of Mount Sinai Heart and professor of Cardiology and Population Health Science and Policy at Icahn School of Medicine at Mount Sinai in New York City.
Heart disease takes a greater toll on certain racial and ethnic groups yet historically, large-scale clinical trials in cardiology have had a disproportionately low inclusion of women and minorities. As a result, physicians have had little data on which to base their clinical decisions when treating these patients. The PLATINUM Diversity study was initiated in October 2014 to provide important insights that can ultimately help physicians customize treatment plans for patient-specific demographics and socioeconomic status.
"The PLATINUM Diversity study is tangible evidence of the commitment by Boston Scientific to raise awareness of the needs of underserved patient communities across the country, and is a critical first step in advancing care for all patients," says Paul Underwood, M.D., medical director of clinical interventional cardiology at Boston Scientific. "Our hope is that these 'real-world' results from the PLATINUM Diversity study will help clinicians, researchers and advocates understand the existing challenges so that we can work collaboratively to close the gender, race and ethnicity gap when treating cardiovascular disease."
The PLATINUM Diversity study is an observational, prospective, multicenter, open-label, single-arm, post-approval study that enrolled 1,501 patients at 52 sites in the U.S. from understudied populations, specifically women, African Americans, Latinos/Hispanics, American Indians or Alaska Natives. All patients in this single arm study received at least one Promus PREMIER drug-eluting stent. Patient data from the PROMUS Element Plus Stent System post-approval study will be included in the full analysis to allow for comparisons to white men, increasing the total number of patients to 4,188. The Promus PREMIER stent system received CE Mark approval in February 2013 and has been available in the U.S. since November 2013. The PROMUS Element Plus stent system received CE Mark approval in 2009 and FDA approval in 2011.