Race, Gender and Socioeconomic Factors
Impact PCI Outcomes
Afirst-of-its-kind study discovered that women and minorities who underwent a percutaneous coronary intervention (PCI)
are at a greater risk of experiencing recurrent cardiac events within
the first year after their procedure compared to Caucasian men.
Those outcomes may be attributable to their race, gender and
socioeconomic status rather than the PCI procedure itself, according
to a late-breaker study titled “Interaction Effects of Race/Ethnicity
and Sex on Outcomes after PCI: A Subanalysis of the PLATINUM
The trial is the first prospective study that enrolled solely women
and minorities, a group that historically has been under-represented
in cardiovascular clinical trials. The purpose of the PLATINUM
Diversity trial was to come up with a novel way to enroll enough
women and minorities to compare outcomes among different gen-
ders and race where results would be statistically valid.
Wayne Batchelor, MD, MHS, FSCAI, an interventional cardiologist at Southern Medical Group in Tallahassee, Fla., along with
Roxana Mehran, MD, MSCAI, director of interventional cardiovascular
research and clinical trials at the Icahn School of Medicine at Mount
Sinai, who served as the study’s co-Principal Investigator. Batchelor
said the impetus for PLATINUM Diversity stemmed in part from past
studies that showed a higher rate of stent thrombosis in African Americans, but noted there were severe limitations of those studies.
“We wanted to design a study to prospectively examine out-
comes across a large sample of women and minorities and compare
that with the same stent used in recent studies of large numbers of
Caucasian men,” said Batchelor. “What is unique about our study is
that, counter to prevailing assumptions, it shows that you can rapidly
enroll women and minorities into a prospective registry and collect
PLATINUM Diversity enrolled U.S. patients who received one
( 1) Promus PREMIER stent and self-identified as being female,
black (of African heritage), Hispanic/Latino, or American Indian/
Alaskan Native. To enrich the study with women and minorities
and allow for comparisons to white men, PLATINUM Diversity
(N= 1,501) patients were pooled with the Promus-Element Plus Post
Approval Study (PE PAS) patients (N= 2,687) for a total study sample
of 4,188 patients.
Within this large cohort, there were 1,417 white and 427 minority
women and 1,635 white and 632 minority men available for analysis.
The subgroup analysis evaluated one-year outcomes in both minority
and white men and women and the inter-related effects of sex and
“What we found was that there were significant differences in adjusted outcomes between these groups, with especially higher risks of
cardiac events in minority women at one year,” Batchelor continued.
“However, these incremental risks appeared to be related to progres-
sion of the patient’s ischemic heart disease more than failure of the
stent due to stent thrombosis or restenosis.”
Dr. Batchelor reported consulting/speaker honoraria from Boston
Scientific, Abbott Medical and Medtronic.
Dr. Mehran’s reported research grants and support from The
Medicines Company, BMS, Astra Zeneca, Lilly/Daiichi Sankyo, Abbott Vascular, Boston Scientific, CSL Behring, Janssen (J+J), Claret
Consulting fees: Advisory board for Janssen (J+J), Medscape and
Wayne Batchelor, MD, FSCAI, presents the results of the PLATINUM Diversity study at the
SCAI 2017 Scientific Sessions in New Orleans.