Young women face higher ischemic risk after PCI than men

ORLANDO, Fla. — In a study of men and women younger than 55 years requiring PCI for ACS, women were at greater ischemic risk but less likely to receive prasugrel than men, according to data presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.

Usman Baber, MD , MS , from Mount Sinai Hospital, and colleagues conducted a post hoc analysis of the retrospective PROMETHEUS study comparing real-world use of prasugrel (Effient, Daiichi Sankyo/Eli Lilly) vs. clopidogrel for patients with ACS undergoing PCI.

Usman Baber

The researchers analyzed differences in prasugrel use by sex, compared ischemic and bleeding risks by sex and compared the efficacy and safety of prasugrel vs. clopidogrel by sex in the PROMETHEUS cohort younger than 55 years (men: n = 3,689; mean age, 49 years; 11% black; women: n = 1,162; mean age, 48 years; 23.6% black).

The primary efficacy endpoint was MACE, defined as death, MI, stroke or revascularization at 90 days and 1 year. The primary safety endpoint was overt bleeding requiring hospitalization.

Among the study population, compared with men, women were more likely to have diabetes, insulin-dependent diabetes, chronic kidney disease and prior peripheral artery disease (P < .001 for all), Baber said during a presentation.

Overall prevalence of prasugrel use was higher in men than women (P = .02). With men, use of prasugrel tended to increase with increasing thrombotic risk factors, but, in a case of treatment paradox, women with four or more risk factors were less likely to receive prasugrel than women with fewer risk factors (four or more, 14.7%; zero, 34.5%), Baber said.

“Increasing burden of ischemic risk was paradoxically associated with less prasugrel use in women,” Baber said.

For both men and women, those with four or more bleeding risk factors were less likely to be assigned prasugrel than those with fewer risk factors.

Unadjusted MACE at 1 year was higher in women (20.2%; 95% CI, 17.1-23.8) than in men (15.9%; 95% CI, 14.2-17.7), but the difference was attenuated after adjustment for baseline characteristics (HR = 1.06; 95% CI, 0.82-1.38), Baber said.

Clinically significant bleeding at 1 year did not differ between the sexes (women, 2.7%; men, 1.9%; adjusted HR = 1.31; 95% CI, 0.85-2.04).

After adjustment, no 90-day or 1-year outcomes differed by sex, but there was a trend toward lower risk for 90-day mortality in women (adjusted HR = 0.41; 95% CI, 0.14-1.15), Baber said.

Choice of antiplatelet agent had no effect on any outcome. “No apparent differential effect of prasugrel vs. clopidogrel by sex on MACE and bleeding outcomes was observed,” Baber said.

– by Erik Swain

Reference:

Baber U, et al. Late-Breaking Clinical Trials – Part 3. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 4-7, 2016; Orlando, Fla.

Disclosure: The study was funded by Eli Lilly and Daiichi Sankyo. Baber reports no relevant financial disclosures.