PROMETHEUS Compares Women and Men Treated With PCI for ACS

May 6, 2016—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the presentation of the PROMETHEUS study, showing that women younger than 55 years of age who undergo percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) are more likely to experience 1-year adverse cardiovascular events due to risk factors such as diabetes and chronic kidney disease. However, they are less likely than men to receive the more-potent antiplatelet therapy prasugrel as opposed to clopidogrel. Additionally, the study found that outcomes for both men and women post-PCI are dependent on their baseline risk factors, not their sex.

The PROMETHEUS results were presented as a late-breaking clinical trial at the SCAI 2016 scientific sessions in Orlando, Florida. The study was accepted for publication and is available online in Catheterization and Cardiovascular Interventions.

According to SCAI, PROMETHEUS was a retrospective, multicenter observational study comparing outcomes in patients treated with clopidogrel versus patients treated with the more potent prasugrel after ACS PCI. The study looked at outcomes up to 1 year and tracked major adverse cardiac events (MACE; defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization at 1 year) and bleeding risks. Clinically significant bleeding was defined as bleeding that required a transfusion or hospitalization.

As summarized by SCAI, the PROMETHEUS study cohort included 4,851 patients (1,162 women [24%] and 3,689 men [76%]). The prevalence of diabetes (41% vs 27.9%) and chronic kidney disease (12.7% vs 7.2%) was higher among women than men.

Irrespective of sex, prasugrel was used in fewer than one-third of patients (31.8% in men vs 28.1% in women; P = .01). Unadjusted, MACE at 1 year was significantly higher in women than in men (21.1% vs 16.2%). After multivariable adjustment (hazard ratio, 1.13; 95% confidence interval, 0.93–1.36), results were no longer significant. Women also had more bleeding than men (3.6% vs 2.2%; P = .01), without differences in adjusted risk (hazard ratio, 1.23; 95% confidence interval, 0.78–1.95).

“Taking into account all risk factors, we wanted to find out if there was a difference in treatment between men and women,” commented the study's Coprincipal Investigator, Usman Baber, MD, and postdoctoral research fellow Jaya Chandrasekhar, MBBS, in the SCAI announcement. The investigators, who are with the Icahn School of Medicine at Mount Sinai in New York, New York, added, “What this study demonstrated is that it is important to objectively assess all the risk factors when considering which therapy to administer. In the real world, physicians are more likely to consider thrombotic risk in men but bleeding risk in women for prescription of prasugrel or clopidogrel.”

Last year at the SCAI 2015 scientific sessions, Dr. Baber presented the initial, 90-day findings from the PROMETHEUS study.