Men and women who undergo percutaneous coronary intervention (PCI) have similar clinical outcomes, according to a sub-analysis of the PRODIGY (Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study) trial recently published in JACC: Cardiovascular Interventions.
Giuseppe Gargiulo, MD, of Bern University Hospital in Bern, Switzerland, and colleagues explored whether gender should play a role in dual antiplatelet therapy (DAPT) after PCI. “Gender impacts age, cardiovascular risk factors, clinical presentation, and angiographic features including extension of disease and vessel size,” they wrote. “However, the impact of gender on clinical outcomes after PCI still remains debated.”
In the original PRODIGY study, PCI patients (n=2013) were randomly assigned to 4 types of stents (bare-metal, zotarolimus-eluting, paclitaxel-eluting, or everolimus-eluting stent) and at 30 days, were randomly assigned to either 6 or 24 months of DAPT. All patients received an aspirin and clopidogrel regimen determined by the DAPT treatment arm they were assigned.
The primary end point was a composite of death, MI, or cerebrovascular accident, with a safety end point of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.
In this sub-analysis, women had higher rates of death, MI, and composite of ischemic events or ischemic and bleeding events at 2 years based on crude events and unadjusted hazard ratios (HR). They were also older, more likely to have hypertension, lower creatinine clearance, and acute coronary syndrome (ACS), but lower severity of coronary artery disease (CAD).
The primary end point occurred in 58 women and 140 men (HR: 0.716; 95% confidence interval [CI]: 0.527-0.972; P=.032), but after multivariate adjustment for baseline imbalances, researchers found no significant differences between genders (adjusted HR: 0.912; 95% CI: 0.658-1.262; P=.577). Major adverse cardiac events and net adverse cardiac events were also not affected by gender (all interaction P values >.05) nor stent type.
Between the 2 DAPT groups, the primary end point was also similar in both genders after adjustment (24-month DAPT adjusted HR: 0.923; 95% CI: 0.586-1.453; P=.729 and 6-month DAPT adjusted HR: 0.828; 95% CI: 0.515-1.331; P=.436; P for interaction=.785). Event rates also did not differ by DAPT duration in either male or female patients (male adjusted HR: 1.080; 95% CI: 0.766-1.522; P=.661 and female adjusted HR: 1.013; 95% CI: 0.588-1.748; P=.962).
BARC type 2, 3, or 5 bleeding occurred in 30 female and 77 male patients, and in this case, male patients treated with DAPT for longer periods experienced higher rates of bleeding whereas female patients did not (male adjusted HR: 3.506; 95% CI: 2.013-6.104; P<.0001 vs female adjusted HR: 0.827; 95% CI: 0.382-1.794; P=.631, with positive interaction testing; P for interaction=.002).
“Although this is a pre-specified analysis of the PRODIGY trial, gender was not used for stratification at the time of randomization,” the authors cautioned. “This study should be regarded as exploratory and hypothesis-generating.”
Both female and male patients had similar rate of long-term ischemic and bleeding events, and prolonged DAPT did not reduce these events in either gender.
They concluded that gender should not be considered a “primary covariate” in determining DAPT durations for patients after PCI.
Gargiulo G, Ariotti S, Santucci A, et al. Impact of sex on 2-year clinical outcomes in patients treated with 6-month or 24-month dual-antiplatelet therapy duration. A pre-specified analysis from the PRODIGY trial. JACC Cardiovasc Interv. 2016. doi:10.1016/j.jcin.2016.05.046.