PRODIGY Analysis Shows Men and Women Have Similar Outcomes in DAPT Duration

August 22, 2016—A prespecified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study) trial was conducted to assess the impact of sex on 2-year outcomes after percutaneous coronary intervention (PCI) in patients randomly allocated to 24-month versus 6-month dual-antiplatelet therapy (DAPT). Giuseppe Gargiulo, MD, et al published the findings online ahead of print in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.

The investigators concluded that the findings suggest that men and women undergoing PCI have similar adjusted 2-year ischemic and bleeding outcomes, despite being characterized by different clinical presentations. They advised that sex failed to emerge as a treatment modifier with respect to DAPT duration, suggesting that decision making in regard to DAPT duration in women should weigh ischemic versus bleeding risks.

According to the investigators, the primary efficacy endpoint of was the composite of death, myocardial infarction, or cerebrovascular accident at 24-month follow-up. The key safety endpoint was type 2, 3, or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria.

As summarized in JACC: Cardiovascular Interventions, women (n = 459; 23.3%) in the analysis of the PRODIGY trial were older and more likely to have hypertension, lower creatinine clearance, and acute coronary syndrome but had a lower severity of coronary artery disease. 

The investigators reported that after adjustment, prolonged DAPT, compared with 6-month treatment, did not reduce the primary endpoint in both men (adjusted hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.766–1.522; P = .661) and women (adjusted HR, 1.013; 95% CI, 0.588–1.748; P = .962) (interaction P = .785). No sex disparity was identified across multiple secondary ischemic endpoints, including overall or cardiovascular mortality, myocardial infarction, and stent thrombosis. There was also no clear sex-related effect on clinically relevant bleeding, including BARC type 3 or 5, TIMI, and GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales, advised the investigators in JACC: Cardiovascular Interventions.