PLATINUM DIVERSITY Assesses Risks of PCI in Women and Minority Patients

November 1, 2016—PLATINUM DIVERSITY, a dedicated stent study conducted exclusively in women and minority patients, evaluated clinical outcomes within the era of contemporary percutaneous coronary intervention (PCI), comparing these results to a parallel cohort of white male patients. The findings from the PLATINUM DIVERSITY trial were presented as a First Report Investigation at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC.

The investigators found that although there were no significant differences in stent-related outcomes, both groups had higher rates of death and myocardial infarction (MI) in the first year following the procedure. The PLATINUM DIVERSITY trial was funded by Boston Scientific Corporation. 

As noted in the TCT press release, the background of the study is that although people of color are expected to represent more than half (52%) of the United States population by 2050, current “all-comers” clinical trial design do not result in a random selection of United States patients. As a result, women and minorities have been significantly underrepresented in most cardiology trials.

The announcement from TCT noted that this multicenter, single-arm, prospective, “enriched” cohort study enrolled 1,501 women and minorities at 52 sites in the United States. Patient information was pooled with data from the PROMUS ELEMENT PAS Study (N = 2,687) and each group was compared with white men enrolled in that study (n = 1,635).

The combined primary endpoint of death, MI, and target vessel revascularization (TVR) at 12 months was 7.6% for white men compared with 9.6% (P = .08) for minorities and 8.6% (P = .33) for women. Data from the individual components of the primary endpoint found that minorities had the highest rate of death and MI, whereas white men had the highest rate of TVR. The death rate was 3.7% in minorities (P = .03) and 3.4% in women (P = .04) compared with 2.2% in white men. The MI rate was 3.1% (P = .0002) in minorities and 1.9% in women (P = .06) compared with 1.1% in white men. The TVR rate was 5.4% (P = .97) in minorities and 4.6% in women (P = .27) compared with 5.5% in white men.

Wayne B. Batchelor, MD, who serves as a coprincipal investigator of the study, commented in the TCT press release, “This study draws important attention to differences in clinical outcomes after stent implantation in women and minorities. The adjusted risk of MI and death/MI was higher in minorities versus white men. In addition, the adjusted risk of death/MI was higher in women than white men with a trend towards higher rates of MI. The similar rates of TVR and stent thrombosis among all three groups suggest that ‘stent failure’ is unlikely to account for the observed differences in outcome. Further study into the cause of these observed gradients of risk is necessary to gain insight into the potential impact on clinical practice.”

Coprincipal investigator Roxana Mehran, MD, added, “The PLATINUM DIVERSITY trial represents an important example of how we can enrich our understanding of outcomes in the underrepresented population. This is the first trial exclusively enrolling women and minorities undergoing PCI and allows for further evaluation of patients who are usually not represented in clinical studies.”