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PLATINUM Diversity: Race, sex, socioeconomic factors impact PCI outcomes
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NEW ORLEANS — Women and minorities who undergo PCI with a drug-eluting stent appear to have greater risk for mortality and recurrent cardiac events within the first year of the procedure compared with white men, researchers reported at the Society for Cardiovascular Angiography and Interventions Annual Meeting.
These outcomes may be attributable to their race/ethnicity, sex and socioeconomic status, rather than the PCI procedure, according to the researchers.
“The United States is becoming an increasingly diverse country. Currently, minorities represent approximately one-third of the U.S. population, and this is expected to increase to over 50% by the year 2050,” Wayne Batchelor, MD, MHS, FSCAI, interventional cardiologist at Southern Medical Group in Tallahassee, Florida, said during a presentation.
Coronary stent trials, however, tend to lack adequate enrollment of women and minorities, he said.
The PLATINUM Diversity study was designed to prospectively enroll only women and minorities. The researchers’ goal was to find a novel way to enroll enough women and minorities to compare outcomes among different sexes and races, where results would be statistically valid.
The study enrolled U.S. patients who underwent PCI with an everolimus-eluting platinum chromium coronary stent system (Promus Premier, Boston Scientific) and self-identified as being female, black, Hispanic/Latino, American Indian or Alaskan Native. The researchers pooled data on women and minorities enrolled in PLATINUM Diversity (n = 1,501) with patient data from the PROMUS Element Plus post-approval study (n = 2,687) to allow for comparisons to white men, increasing the total number of patients to 4,188.
The large cohort comprised 1,417 white women, 427 minority women, 1,635 white men and 632 minority men. The subgroup analysis evaluated 1-year outcomes in women and minorities, compared with white men. Follow-up was “robust” in all groups, he said.
The main findings included:
Severe clinical and angiographic risk factors, including diabetes, renal disease, hypertension and coronary calcification were more prevalent in nonwhite individuals and women vs. men, whereas white men were more likely to present with thrombus.
Unadjusted rates of combined death, MI and target vessel revascularization were higher in minority women vs. white men: 11.4% vs. 7.6% (P = .02).
Unadjusted rates of death were higher in white women and minority men and women vs. white men (3.5%, 3.7% and 3.6%, respectively, vs. 2.2%).
Unadjusted rates of combined death and MI were higher in minority men and women vs. white men (5.9% and 7.6% vs. 3%).
After accounting for differences in baseline clinical and angiographic risk factors, minority women still showed a higher rate of combined death, MI and TVR (OR = 1.49; 95% CI, 1.01-2.17), combined death and MI (OR = 2.86; 95% CI, 1.7-4.76) and MI alone (OR = 3.7; 95% CI, 1.82-7.69) vs. white men. This finding was driven by a nearly fourfold increased risk for MI.
After accounting for differences in baseline clinical and angiographic risk factors, rates of repeat hospitalization for TVR and stent thrombosis were similar across all four groups included in the analysis.
Important to note, Batchelor said, “minority women showed a 50% increased risk of death/MI and a nearly threefold increase in MI.”
During a discussion of the trial, he said the incremental risks in this study appear related to the progression of a patient’s CVD rather than failure of the stent. Further, he said “there’s some hint that there may be differences in biology” between the groups, which will be a point of further investigation.
Batchelor also presented findings from an initial look at socioeconomic disparities in PLATINUM Diversity. Among patients who disclosed annual household income, the primary composite endpoint of death, MI and TVR at 1 year was highest among those with an annual income less than $25,000 (9.8%), and increased slightly with rising income (8.1% for annual income of $25,000 to $49,999; 4.1% for annual income greater than $50,000). After adjustment for other clinical and angiographic variables, annual income remained an independent predictor of death (OR = 1,82; 95% CI, 1.03-3.13) and combined death and MI (OR = 1.67; 95% CI, 1.08-2.56). Batchelor said socioeconomic disparities are an area of ongoing research in this study.
“We wanted to design a study to prospectively examine outcomes 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,” Batchelor said in a press release. “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 statistically valid data.”
He concluded that “these results highlight the heterogeneity conferred by sex and race and suggest further study into the biologic, social, behavioral and economic factors that impact CV risk after [DES].”
PLATINUM Diversity is part of the Boston Scientific Close the Gap initiative, which aims to promote health equity by reducing barriers to care for all patients. – by Katie Kalvaitis
Reference:
Batchelor WB, et al. Late-Breaking Clinical Trials II. Presented at: Society for Cardiovascular Angiography and Interventions Annual Meeting; May 10-13, 2017; New Orleans.
Disclosure: Batchelor reports receiving consultant/speaker honoraria from Abbott Medical, Boston Scientific and Medtronic.